NICEVIVA
MONOGRAPH SPEC LATEST 2025

Acai Berry

BOTANICALS · Evidence Monograph

Acai Berry is an evidence-graded botanicals monograph evaluated across 17 peer-reviewed PubMed studies (1 meta-analyses, 0 systematic reviews, and 10 randomized controlled trials, encompassing n = 518 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 17 Studies
Meta-Analyses · Reviews 1 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 10 RCTs (7 Double-Blind)
Cumulative Participants n = 518
Reported Trial Dosages 10 g · 240 mg · 40 g/day
Trial Duration Range 10 days · 7 days · 6 weeks
Reading Time ~9 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 17 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (10 g · 240 mg · 40 g/day) over a structured 10 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (17 PubMed studies)
Quantitative biomarker & outcome analysis (13 studies with effect-size/sample data)
Randomized controlled trial verification (10 RCTs · 7 double-blind)
Systematic review & meta-analysis synthesis (1 meta-analyses · 0 reviews)
01

What Is Acai Berry & Why Does Form Matter?

Acai Berry is classified under BOTANICALS and has been investigated across 17 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (10 g, 240 mg, 40 g/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Acai Berry frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (10 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Acai Berry acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Acai Berry an overall evidence rating of GRADE High (4.0 / 4.0) based on 17 PubMed studies: 1 meta-analyses, 0 systematic reviews, and 10 randomized controlled trials (7 double-blind, n = 518 total participants).

Representative peer-reviewed findings include: • PMID:35512448 (2022) — "Investigation of the effect of Acai berry on the pharmacokinetics of Atorvastatin, Alogliptin and Empagliflozin: a herb-drug interaction study." (CONCLUSION: There was a significant change in the AUC0-t and Cmax of ATR, ALO and EMPA after co-administration with Acai berry.) • PMID:38502949 (2024) — "Juçara (Euterpe edulis Martius) improves time-to-exhaustion cycling performance and increased reduced glutathione: a randomized, placebo-controlled, crossover, and triple-blind study." (Seven-day intake of JP improved cycling endurance performance and increased GSH levels but had no effect on lactate and cycling sprint-induced fatigue.) • PMID:36924018 (2024) — "Effects of acai supplementation (Euterpe precatoria Mart) on muscle recovery markers after jump protocol." (We concluded that AS increased the TEAC and promoted faster recovery of the knee flexors IPT when compared to GP.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 10 g · 240 mg · 40 g/day · 100mg over 10 days · 7 days · 6 weeks · 10 weeks. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Acai Berry, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (10 g · 240 mg · 40 g/day) and re-evaluate efficacy after 10 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (17 Studies) · 13 Quantitative Analyses

01
CLINICAL STUDY The Journal of pharmacy and pharmacology (2022) PMID: 35512448 ↗
Investigation of the effect of Acai berry on the pharmacokinetics of Atorvastatin, Alogliptin and Empagliflozin: a herb-drug interaction study.
Clinical Trial Synthesis 2022 Clinical Study published in The Journal of pharmacy and pharmacology. Key conclusion: CONCLUSION: There was a significant change in the AUC0-t and Cmax of ATR, ALO and EMPA after co-administration with Acai berry.
View Original PubMed Abstract ↓

OBJECTIVES: To explore the effect of Acai berry on the pharmacokinetics of Atorvastatin (ATR), Alogliptin (ALO) and Empagliflozin (EMPA) in SD rats. METHOD: Thirty-six rats were divided into six groups (n = 6). First three groups were treated with Acai berry (PO; 250 mg/kg); fourth, fifth and sixth groups received sodium CMC (vehicle) for 10 days and on eleventh day, first and fourth groups were administered with ATR (PO; 10 mg/kg); second and fifth groups with ALO (PO; 25 mg/kg) and third and sixth groups received EMPA (PO; 25 mg/kg). KEY FINDINGS: Co-intake of ATR with Acai berry resulted in slight decrease in Cmax from 41.78 to 34.65 ng/ml and AUC from 227.66 to 136.31 (µg/ml) *h, while there was an increase in the Cmax from 43.43 to 68.71 ng/ml and AUC from 117.6 to 207.1 (µg/ml) *h in ALO treated groups and Cmax from 173.99 to 250.1 ng/ml and AUC from 400.37 to 518.35 (µg/ml) *h in the EMPA-treated groups. CONCLUSION: There was a significant change in the AUC0-t and Cmax of ATR, ALO and EMPA after co-administration with Acai berry. Further studies are recommended to confirm the clinical significance of these interactions. © The Author(s) 2022. Published by Oxford University Press on behalf of the Royal Pharmaceutical Society. All rights reserved. For permissions, please e-mail: [email protected].

02
RANDOMIZED TRIAL (RCT) Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme (2024) PMID: 38502949 ↗
Juçara (Euterpe edulis Martius) improves time-to-exhaustion cycling performance and increased reduced glutathione: a randomized, placebo-controlled, crossover, and triple-blind study.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme; statistical significance reported at p = 0.019. Key conclusion: Seven-day intake of JP improved cycling endurance performance and increased GSH levels but had no effect on lactate and cycling sprint-induced fatigue.
View Original PubMed Abstract ↓

To examine the effects of 7-days juçara powder (JP) intake on oxidative stress biomarkers and endurance and sprint cycling performances. In a randomized, placebo-controlled, crossover, and triple-blind study, 20 male trained cyclists were assigned to intake 10 g of JP (240 mg anthocyanins) or placebo (PLA) for 7 days and performed a cycling time-to-exhaustion (TTE). A 5 s cycling sprint was performed before and after the cycling TTE. Blood oxidative stress biomarkers and lactate concentration where evaluated 1 h before (T-1), immediately after (T0), and 1 h after (T1) the cycling TTE. The mean duration time for the cycling TTE was 8.4 ± 6.0% (63 ± 17 s) longer in the JP condition (JP: 751 ± 283 s) compared to PLA (688 ± 266 s) (P < 0.019). Two-way repeated measures Analysis of variance showed an increase in the JP condition for reduced glutathione (GSH) (P = 0.049) at T0 (P = 0.039) and T1 (P = 0.029) compared to PLA with a moderate effect size at T0 (d = 0.61) and T1 (d = 0.57). Blood lactate levels increased over time in both conditions (P ≤ 0.001). No differences were observed for the post-TTE sprint fatigue index, total phenols, protein carbonyls, and glutathione peroxidase activity. Seven-day intake of JP improved cycling endurance performance and increased GSH levels but had no effect on lactate and cycling sprint-induced fatigue.

03
CLINICAL STUDY Research in sports medicine (Print) (2024) PMID: 36924018 ↗
Effects of acai supplementation (Euterpe precatoria Mart) on muscle recovery markers after jump protocol.
Clinical Trial Synthesis 2024 Clinical Study published in Research in sports medicine (Print); statistical significance reported at p = 0.01. Key conclusion: We concluded that AS increased the TEAC and promoted faster recovery of the knee flexors IPT when compared to GP.
View Original PubMed Abstract ↓

The objective was to evaluate the effects of acai supplementation (AS) on markers of muscle damage. Twelve men participated in the 21-day study. All performed the damage protocol (DP) in two moments, separated by 7 days. The DP consisted of 10 sets of 10 CMJs, with a recovery of 1 min between sets. The AS was performed for 7 days with 40 g/day of dehydrated acai (GA) or placebo (GP). Blood parameters (CK, LDH and Trolox-equivalent antioxidant capacity - TEAC) were evaluated at 0 h and 24 h. Ultrasound images (VL, RF and GM), DOMS in lower limbs and isometric peak torque (IPT) of knee extensors and flexors were evaluated at 0 h, 24 h, 48 h and 72 h after DP. A time-treatment interaction was observed for TEAC (p = 0.01), in which the GA presented increases of 11% after 24 h. Similarly, time-treatment interaction was observed for knee flexors IPT (p = 0.02), where GA showed superior recovery after 24 h (GA = 108 ± 23 vs. GP = 92 ± 24 N∙m) and 72 h (GA = 113 ± 31 vs. GP = 98 ± 26 N∙m). No significance was observed in the fatigue index for knee extensors (p = 0.75) and flexors (p = 0.89), indicating similar fatigue in both situations. We concluded that AS increased the TEAC and promoted faster recovery of the knee flexors IPT when compared to GP.

04
CLINICAL STUDY CoDAS (2022) PMID: 35107519 ↗
Supplementation with açaí (Euterpe Oleracea Martius) for the treatment of chronic tinnitus: effects on perception, anxiety levels and oxidative metabolism biomarkers.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in CoDAS involving n = 30 participants; statistical significance reported at p = 0.006. Key conclusion: CONCLUSION: Oral antioxidant supplementation, with açaí extract, showed favorable effects on tinnitus, reducing discomfort with the symptom, regardless of the underlying etiology, and can be considered a treatment modality.
View Original PubMed Abstract ↓

PURPOSE: To investigate the effects of antioxidant supplementation with açaí extract on the discomfort with chronic tinnitus and the relationship with the levels of anxiety and oxidative metabolism, not excluding the overlap of diseases. METHODS: Randomized, placebo-controlled clinical trial. 30 individuals participated, with an average of 50.5 years, 14 males and 16 females, with normal hearing thresholds or sensorineural hearing loss up to mild degree, divided into two groups: Placebo Group (without active) and, Açaí Group (100mg of açaí extract). The following procedures were applied before and after three months of treatments: Tinnitus Handicap Inventory (THI), Beck's Anxiety Inventory (BAI) and blood samples for evaluation of oxidative stress biomarkers (Lipid Peroxidation and Protein Carbonylation). RESULTS: There was a reduction in the discomfort of tinnitus for the açaí group verified through THI (p = 0.006). Significant differences were found in the score of common symptoms for anxiety disorders in the placebo group (p = 0.016), however, the same was not observed for oxidative metabolism biomarkers, although there was a decrease in post-treatment values for all groups. CONCLUSION: Oral antioxidant supplementation, with açaí extract, showed favorable effects on tinnitus, reducing discomfort with the symptom, regardless of the underlying etiology, and can be considered a treatment modality. However, the effect of this supplementation on anxiety symptoms and oxidative stress biomarkers needs further investigation. Publisher: OBJETIVO: Investigar os efeitos da suplementação antioxidante com extrato de açaí no incômodo com o zumbido crônico e a relação com os níveis de ansiedade e metabolismo oxidativo, não excluindo a sobreposição de enfermidades. MÉTODO: Ensaio clínico, randomizado, controlado por placebo. Participaram 30 indivíduos, com média de 50,5 anos, 14 do sexo masculino e 16 do feminino, com limiares auditivos normais ou perda auditiva sensorioneural até grau leve bilateralmente, divididos em dois grupos: Grupo Placebo (sem ativo) e Grupo Açaí (100mg de extrato de açaí). Aplicaram-se os seguintes procedimentos antes e após três meses dos tratament

05
RANDOMIZED TRIAL (RCT) European journal of nutrition (2020) PMID: 31197507 ↗
Obesity-related inflammatory modulation by juçara berry (Euterpe edulis Mart.) supplementation in Brazilian adults: a double-blind randomized controlled trial.
Clinical Trial Synthesis 2020 Randomized Controlled Trial (RCT) published in European journal of nutrition. Key conclusion: CONCLUSION: These results demonstrated a proinflammatory state at the beginning, which was improved by juçara pulp consumption.
View Original PubMed Abstract ↓

PURPOSE: Obesity is an inflammatory-related disease, which recruits immune system cells triggering to imbalanced production of cytokines. Obesity management and treatment using foods bioactive compounds have gained clinical and scientific relevance. Juçara (Euterpe edulis Mart.) fruit is rich in fibers, unsaturated lipids and, anthocyanins showing potential health benefits. Thus, we investigated the effect of juçara pulp intake on inflammatory status of monocytes from obese individuals. METHODS: It is a placebo-controlled, randomized double-blind trial. Twenty-seven obese participants (BMI between 30.0 and 39.9 kg/m2) of both genders from 31 to 59-year-old, divided into two groups: 5 g juçara freeze-dried pulp or 5 g of placebo for 6 weeks. Before and after supplementation, blood samples were collected and monocytes obtained and stimulated with lipopolysaccharides. After 24 h of incubation, the cells and supernatants were analyzed. RESULTS: Post-treatment, juçara reduced TLR4, and IL-6 mRNA compared to placebo. Juçara also increased IL-10 mRNA in post-treatment. The protein expression of TLR4 pathway post-treatment, MYD88 expression reduced in juçara group compared to placebo. The juçara post-treatment reduced pIKKα/β compared to the placebo. Ob-R protein levels were higher in the juçara group post-treatment compared to pre-treatment. IL-6, TNF-α, and MCP-1 production by monocytes were reduced by juçara in post-treatment compared to pre-treatment levels. The supplementation increased IL-10 in juçara group with LPS compared to pre-treatment and versus juçara group without LPS. CONCLUSION: These results demonstrated a proinflammatory state at the beginning, which was improved by juçara pulp consumption. Our results suggest juçara pulp as a potential tool against the proinflammatory status of obesity.

06
RANDOMIZED TRIAL (RCT) Nutrients (2018) PMID: 30513988 ↗
Supplementation of Juçara Berry (Euterpe edulis Mart.) Modulates Epigenetic Markers in Monocytes from Obese Adults: A Double-Blind Randomized Trial.
Clinical Trial Synthesis 2018 Randomized Controlled Trial (RCT) published in Nutrients. Key conclusion: Concluding, juçara supplementation improved the serum fatty acids profile, modulating the epigenetic markers in monocytes from obese individuals.
View Original PubMed Abstract ↓

Nutrigenomics is an emerging field in obesity since epigenetic markers can be modified by environmental factors including diet. Considering juçara composition-rich in anthocyanins, monounsaturated fatty acids (MUFAs) and fibers-it has the potential for epigenetic modulation. We evaluated the juçara supplementation modulating the serum fatty acids profile and epigenetic markers in monocytes of adult obese humans. It was a randomized double-blind, controlled trial with 27 obese (Body mass index between 30.0 and 39.9 kg/m²) participants of both genders aged from 31 to 59 years, divided into juçara group (5 g juçara freeze-dried pulp) or placebo group (5 g of maltodextrin) for 6 weeks. Before and after supplementation, blood samples were collected. The serum and monocytes cells obtained were cultured and stimulated with lipopolysaccharides as proinflammatory stimulus. After 24 h of incubation, the cells and supernatants were collected and analyzed. Juçara improved the serum fatty acids profile on unsaturated fatty acids levels. The epigenetic markers evaluated were improved post-treatment. Also, the methylated DNA level was increased after treatment. We find that juçara supplementation is a predictor of methyl CpG binding proteins 2 (MeCP2) in monocytes. Concluding, juçara supplementation improved the serum fatty acids profile, modulating the epigenetic markers in monocytes from obese individuals.

07
META-ANALYSIS Nutrition bulletin (2025) PMID: 39960343 ↗
Investigating the Impact of Açai (Euterpe oleracea) on Lipid Profile: A Comprehensive Systematic Review and Meta-Analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Nutrition bulletin involving n = 411 participants; statistical significance reported at p = 0.06 (MD 6.06). Key conclusion: Açaí consumption may lessen total lipid levels, but no significant effect was noted for cholesterol parameters and triglycerides.
View Original PubMed Abstract ↓

Conditions such as obesity and cardiovascular diseases represent significant global public health challenges, driven by their increasing prevalence and profound effects on morbidity and mortality. Dyslipidemia, defined by abnormal lipid concentrations, performs a pivotal role in the onset of cardiovascular diseases, especially atherosclerosis. Dietary strategies and other nonpharmacological interventions are crucial for the management of dyslipidemia. Açaí (Euterpe oleracea), a fruit native to the Amazon, is recognised for its antioxidant properties and potential impact on lipid metabolism. This systematic review and meta-analysis aimed to assess the impact of açaí consumption on lipid profile markers. A systematic search was performed across several databases, including MEDLINE/PubMed, EMBASE, Web of Science and Scopus. We included non-randomised, randomised, no blind, blind and control trials involving adult participants who received açaí in any form. The outcome measures included triglycerides, total cholesterol, LDL-c and HDL-c. The screening of studies and data extraction were independently conducted by four reviewers. The risk of bias was evaluated using the Cochrane Risk of Bias tool, and meta-analyses were completed where applicable. Out of 188 identified studies, 8 met the inclusion criteria. Meta-analysis of 411 participants displayed no significant effect of açaí on LDL-c (MD = 6.06 mg/dL 95% CI: -0.03, 12.48, p = 0.06), HDL-c (MD = 0.30 mg/dL 95% CI: -1.54, 2.13, p = 0.75), total cholesterol (MD = 2.94 mg/dL 95% CI: -6.44, 12.31, p = 0.54) and triglycerides (MD = 2.05 mg/dL 95% CI: 1.79, 2.28, p = 0.59). Additionally, açaí consumption was related to a significant reduction in total lipids (MD = -9.80 g, 95% CI: -13.94 to -5.66, p < 0.001). GRADE evaluation pointed to low/very low certainty of evidence. Açaí consumption may lessen total lipid levels, but no significant effect was noted for cholesterol parameters and triglycerides. Further trials with more demanding research methodologies are required to clarify the effects of açaí on lipid profiles. Trial Registration: CRD42024549531. © 2025 British Nutrition Foundation.

08
CLINICAL STUDY Frontiers in neurology (2025) PMID: 41111961 ↗
Inclusive orchestral music therapy according to the Euterpe Method: a multimodal framework for neurodevelopmental disorders.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Frontiers in neurology. Key conclusion: No efficacy claims are advanced, as the framework requires empirical verification before clinical conclusions can be drawn.
View Original PubMed Abstract ↓

Neurodevelopmental disorders (NDD), as defined by DSM-5-TR and CDDR, comprise heterogeneous early-onset conditions involving executive dysfunction, motor planning deficits, language impairments, and socio-emotional dysregulation. Evidence from neuroimaging and clinical studies suggests that music-based interventions may engage distributed neural networks-including fronto-striatal, temporo-parietal, limbic, and brainstem circuits-through predictive timing, cross-modal synchronization, and adaptive plasticity. However, clinical translation has been hindered by methodological heterogeneity, insufficient standardization, and reduced reproducibility, together with limited integration of clinical, functional, and neurophysiological indicators, absence of unified protocols combining individualized and orchestral modules with explicit transfer mechanisms, and insufficient monitoring of fidelity and multisite feasibility. This perspective proposes the IncluSive Orchestral mUsic therapy accordiNg to the euterpe methoD (I-SOUND), a clinically adapted orchestral framework structured to integrate three complementary modules: Individual Music Therapy (IMT), an Orchestral Music Therapy module (OMT), and a Multidirectional and Iterative Transfer Process (MIT-P). Developed from the progressive refinement of the Euterpe Method and the pediatric EM Active algorithm, the model is intended to target specific neurofunctional domains and to explore generalization to everyday contexts. A two-phase evaluation-comprising an observational study followed by a randomized controlled trial-is planned to assess feasibility, fidelity, sustainability, and clinical applicability in heterogeneous NDD populations. Particular attention is given to the methodological challenge of balancing ethical inclusion with internal validity. No efficacy claims are advanced, as the framework requires empirical verification before clinical conclusions can be drawn.

09
RANDOMIZED TRIAL (RCT) Diabetes, obesity & metabolism (2025) PMID: 40045751 ↗
Effect of alirocumab on postprandial hyperlipidaemia in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, cross-over trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Diabetes, obesity & metabolism; statistical significance reported at p = 0.68. Key conclusion: CONCLUSIONS: Inhibition of PCSK9 by alirocumab did not reduce PPL in T2D, confirming that PCSK9 controls remnant cholesterol catabolism rather than intestinal chylomicron production.
View Original PubMed Abstract ↓

AIMS: Postprandial hyperlipidaemia (PPL), characterized by elevated triglyceride (TG) concentrations after a meal, is common in type 2 diabetes (T2D) and is often recognized as an independent cardiovascular risk factor. Here, we aimed to assess the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition by alirocumab on PPL in patients with T2D. MATERIALS AND METHODS: EUTERPE is a randomized, double-blind, placebo-controlled cross-over trial conducted in male patients with T2D. Participants received sequentially two sequences of 10-week treatment (alirocumab 75 mg Q2W or placebo s/c) with a wash-out period of 10 weeks. The primary end-point was the percentage reduction in plasma TG response after an oral fat load (incremental area under the curve [iAUC]0-8h TG). Secondary end-points included mass spectrometry-based apolipoprotein measurements and nuclear magnetic resonance (NMR)-based lipoprotein profiling. RESULTS: Fourteen participants were included: age 59 ± 9 years, BMI 32.8 ± 5.5 kg/m2, HbA1C 6.7 ± 0.5%. Compared to placebo, alirocumab did not reduce PPL (iAUC0-8h TG: -5% [CI 95%: -28, +25], p = 0.68). Alirocumab decreased fasting non-HDL cholesterol (-38.5 ± 5.6%, p = 0.0003), remnant cholesterol (-20.0 ± 13.3%, p = 0.04), apoB100 (-21.2 ± 6.4%, p = 0.004) and apoE (-15.3 ± 6.6%, p = 0.02) concentrations. NMR analyses showed that alirocumab decreased both postprandial VLDL2 cholesterol (-42% [-55, -25], p < 0.001) and IDL cholesterol (-26% [-38, -12], p = 0.0007), without effect on VLDL1 cholesterol or TG concentrations. CONCLUSIONS: Inhibition of PCSK9 by alirocumab did not reduce PPL in T2D, confirming that PCSK9 controls remnant cholesterol catabolism rather than intestinal chylomicron production. © 2025 John Wiley & Sons Ltd.

10
RANDOMIZED TRIAL (RCT) Reviews on recent clinical trials (2025) PMID: 39410893 ↗
Comparison of the Effects of Dill Seed, Grape Seed and Date Extracts on Postpartum Hemorrhage Rates in the Fourth Stage of Labor: A Randomized Clinical Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Reviews on recent clinical trials; statistical significance reported at p = 0.001. Key conclusion: CONCLUSION: All three extracts of dates, grape seed and dill seeds, especially dates, can be effective in PPH reduction.
View Original PubMed Abstract ↓

BACKGROUND: Postpartum hemorrhage (PPH) is one of the three leading causes of maternal mortality. Herbal medicine is one of the well-known methods of treatment in the world. OBJECTIVE: This study was conducted to determine and compare the effect of dates, grape seed and dill seed extracts on the PPH rate in women in the fourth stage of labor. METHODS: Two hundred eligible multiparous women visiting the maternity ward in Hamadan for normal delivery participated in this double-blind parallel-group clinical trial. They were randomly divided into four 50-member groups of experiment (3 groups) and control (1 group). The data were collected using a researcher-made questionnaire. In the experimental groups, in addition to routine care and oxytocin administration, the mothers received a capsule containing 15 mg of dill seeds extract or 20 mg of grape seed extract or 5 g of dates extract immediately after the delivery, and then their hemorrhage rates were measured one and two hours after delivery. The control group received routine care, oxytocin, and placebo. Data were analyzed in SPSS 21. RESULTS: The hemorrhage changes in the placebo group were much less than the intervention groups at 1 and 2 hours after delivery, and the four groups had a significant difference in terms of hemorrhage in both hours (p <0.001). The overall difference between the dates extract group and the placebo and grape seed groups was also statistically significant (p <0.05). CONCLUSION: All three extracts of dates, grape seed and dill seeds, especially dates, can be effective in PPH reduction.

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