NICEVIVA
MONOGRAPH SPEC LATEST 2026

Vitamin B2 (Riboflavin)

VITAMINS · Evidence Monograph

Vitamin B2 (Riboflavin) is an evidence-graded vitamins monograph evaluated across 64 peer-reviewed PubMed studies (4 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials, encompassing n = 1,612,792 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 64 Studies
Meta-Analyses · Reviews 4 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (6 Double-Blind)
Cumulative Participants n = 1,612,792
Reported Trial Dosages 10 mg · 2 mg · 100 g
Trial Duration Range 4 months · 6 months · 2 months
Reading Time ~32 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis (supported by 64 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (10 mg · 2 mg · 100 g) over a structured 4 months evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Bioactive Coenzyme or Standardized Vitamin Form
Prioritize bioactive coenzyme forms (such as methylated B-vitamins or cholecalciferol D3) matched to water- or fat-soluble absorption pathways.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Steady daytime energy and correction of subclinical deficiency markers over 4–8 weeks.
Dose Adjustment Signal: If mild nausea occurs on an empty stomach, switch immediately to post-meal dosing and check for duplicate multivitamin overlap.
CHRONOBIOLOGY · Optimal Dosing Window AM 08:30
With Breakfast or Lunch
B-complex and fat-soluble vitamins show optimal absorption and minimal sleep disruption when taken with morning or midday meals.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary vitamins clinical efficacy (64 PubMed studies)
Quantitative biomarker & outcome analysis (21 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 6 double-blind)
Systematic review & meta-analysis synthesis (4 meta-analyses · 0 reviews)
01

What Is Vitamin B2 (Riboflavin) & Why Does Form Matter?

Vitamin B2 (Riboflavin) is classified under VITAMINS and has been investigated across 64 peer-reviewed PubMed publications for its role in cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis.

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 mg, 2 mg, 100 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Vitamin B2 (Riboflavin) 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 (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Vitamin B2 (Riboflavin) acts on pathways governing cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Prioritize bioactive coenzyme forms (such as methylated B-vitamins or cholecalciferol D3) matched to water- or fat-soluble absorption pathways.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Vitamin B2 (Riboflavin) an overall evidence rating of GRADE High (4.0 / 4.0) based on 64 PubMed studies: 4 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials (6 double-blind, n = 1,612,792 total participants).

Representative peer-reviewed findings include: • PMID:15736448 (2004) — "Vitamin B2 (riboflavin) and a mixture of vitamin B2 and C affects MMC efficiency in aerated media under irradiation." (This effect opens a new pathway for specific protection of normal mammalian cells (with a high O2-content) under treatment with ionizing radiation.) • PMID:15189780 (2004) — "Potentiation by amino acid of the therapeutic effect of highly purified vitamin B2 in mice with lipopolysaccharide-induced shock." (Clinical trials of vitamin B2 plus amino acids for the treatment of patients with sepsis would appear to be warranted.) • PMID:9989479 (1999) — "Is thallium-induced nephrotoxicity in rats connected with riboflavin and/or GSH?--reconsideration of hypotheses on the mechanism of thallium toxicity." (From our investigations we conclude that there is no relation between thallium-induced nephrotoxicity and riboflavin and/or GSH.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)MD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 41123035-1.94 (-5.74–1.86)PMID 38999805-1.26 (-2.23–-0.29)-6.9Null (0)3Metric: MD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Bioactive Coenzyme or Standardized Vitamin Form. Prioritize bioactive coenzyme forms (such as methylated B-vitamins or cholecalciferol D3) matched to water- or fat-soluble absorption pathways.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 10 mg · 2 mg · 100 g · 82 µg over 4 months · 6 months · 2 months · 12 weeks. Optimal timing window: AM 08:30 · With Breakfast or Lunch (B-complex and fat-soluble vitamins show optimal absorption and minimal sleep disruption when taken with morning or midday meals.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Steady daytime energy and correction of subclinical deficiency markers over 4–8 weeks.

Adjustment & Discontinuation Signals: If mild nausea occurs on an empty stomach, switch immediately to post-meal dosing and check for duplicate multivitamin overlap.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Vitamin B2 (Riboflavin), 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 (AM 08:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (10 mg · 2 mg · 100 g) and re-evaluate efficacy after 4 months.
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 (64 Studies) · 21 Quantitative Analyses

01
CLINICAL STUDY Anticancer research (2004) PMID: 15736448 ↗
Vitamin B2 (riboflavin) and a mixture of vitamin B2 and C affects MMC efficiency in aerated media under irradiation.
Clinical Trial Synthesis 2004 Clinical Study published in Anticancer research. Key conclusion: This effect opens a new pathway for specific protection of normal mammalian cells (with a high O2-content) under treatment with ionizing radiation.
View Original PubMed Abstract ↓

Vitamin B2 (Riboflavin) acts as a strong radiation protecting agent in Escherichia coli bacteria (AB1157) in aerated media. This ability is reinforced by the addition of vitamin C. Under the influence of gamma-radiation, vitamin B2 completely suppresses the cytostatic activity of mitomycin C (MMC). In the presence of both vitamins, B2 and C, MMC is converted from an efficient cytostatic to a rather strong radiation protecting agent. This effect opens a new pathway for specific protection of normal mammalian cells (with a high O2-content) under treatment with ionizing radiation.

02
CLINICAL STUDY European journal of pharmacology (2004) PMID: 15189780 ↗
Potentiation by amino acid of the therapeutic effect of highly purified vitamin B2 in mice with lipopolysaccharide-induced shock.
Clinical Trial Synthesis 2004 Clinical Study published in European journal of pharmacology; statistical significance reported at p = 0.05. Key conclusion: Clinical trials of vitamin B2 plus amino acids for the treatment of patients with sepsis would appear to be warranted.
View Original PubMed Abstract ↓

The aim of this experiment was to clarify whether an amino acid supplement could enhance the therapeutic effect of vitamin B2 (riboflavin 5'-sodium phosphate; purity > 97%) in mice with lipopolysaccharide-induced shock. Six hours after injection of a lethal dose of lipopolysaccharide, treatment (6-h i.v. infusion) was commenced. All mice died in the groups treated with saline or aminolevane (an amino acids mixture used to treat hepatopathy); however, the survival rates in the vitamin B2 (10 mg/kg/6 h) and vitamin B2 plus aminolevane groups were 45% (P < 0.05) and 80% (P < 0.05), respectively. Valine (200 mg/kg/6 h) alone had little effect on the survival rate (10%), but the combination of vitamin B2 (10 mg/k/g/6 h) and valine was highly effective (80%, P < 0.05). Clinical trials of vitamin B2 plus amino acids for the treatment of patients with sepsis would appear to be warranted. Copyright 2004 Elsevier B.V.

03
CLINICAL STUDY Journal of applied toxicology (1999) PMID: 9989479 ↗
Is thallium-induced nephrotoxicity in rats connected with riboflavin and/or GSH?--reconsideration of hypotheses on the mechanism of thallium toxicity.
Clinical Trial Synthesis 1999 Clinical Study published in Journal of applied toxicology. Key conclusion: From our investigations we conclude that there is no relation between thallium-induced nephrotoxicity and riboflavin and/or GSH.
View Original PubMed Abstract ↓

Adult female Wistar rats (Han:Wist) were injected with 2 mg of Tl2SO4 per 100 g body weight. Parameters of nephrotoxicity were urinary volume and protein excretion as well as blood urea nitrogen concentration. Thallium concentrations were determined in renal cortex and medulla. There was no effect of different schedules of vitamin B2 (riboflavin) treatment on thallium nephrotoxicity. Glutathione (GSH) concentration was not decreased by thallium in renal cortex or in medulla. The increase of GSH concentration in renal tissue by N-acetylcysteine pretreatment did not influence thallium nephrotoxicity. Buthionine sulphoximine diminished thallium nephrotoxicity by a significant decrease of thallium concentration in renal medulla, which was caused by enhanced urinary excretion of thallium. From our investigations we conclude that there is no relation between thallium-induced nephrotoxicity and riboflavin and/or GSH.

04
CLINICAL STUDY Mutation research (1992) PMID: 1383790 ↗
Potentiation of sodium chromate(VI)-induced chromosomal aberrations and mutation by vitamin B2 in Chinese hamster V79 cells.
Clinical Trial Synthesis 1992 Clinical Study published in Mutation research. Key conclusion: These and other previous studies suggest that vitamin B2 enhances the clastogenic and mutagenic action of chromate compounds, through its ability to directly reduce chromium(VI) in cells.
View Original PubMed Abstract ↓

The effect of vitamin B2, which is capable of reducing chromium(VI) to chromium(V), on chromosomal aberrations and mutation caused by Na2CrO4 was investigated in Chinese hamster V79 cells. Pretreatment with 200 microM vitamin B2 (riboflavin) for 24 h prior to exposure to Na2CrO4 (2.5-5 microM) resulted in an increase of metal-induced chromosomal aberrations and mutation at the HGPRT locus. These and other previous studies suggest that vitamin B2 enhances the clastogenic and mutagenic action of chromate compounds, through its ability to directly reduce chromium(VI) in cells.

05
RANDOMIZED TRIAL (RCT) European journal of nutrition (2025) PMID: 41417236 ↗
Assessment of vitamin A, vitamin B(2), vitamin B(12), vitamin K, folate, and choline status following 4 months of multinutrient supplementation in healthy vegans: a randomised, double-blind, placebo-controlled trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in European journal of nutrition. Key conclusion: CONCLUSION: A multinutrient supplement containing 82 µg of vitamin B12 per day significantly positively affected vitamin B12 blood biomarkers in healthy vegans.
View Original PubMed Abstract ↓

PURPOSE: The aim of the MultiVeg study, a double-blind, randomised controlled trial (RCT), was to investigate the nutritional status of healthy vegans following 4 months of multinutrient supplementation. METHODS: A double-blind, RCT was conducted with 72 vegan adults (19-57 years) in Germany. Data on anthropometric parameters, dietary nutrient intake, and nutritional status were collected. The nutritional status of the participants was assessed at baseline and after 4 months. The results were compared between groups using ANCOVA. The results for vitamins and choline are presented here. RESULTS: After adjustment for baseline values, age, sex, and multiple testing, no significant between-group differences in biomarker concentration changes from baseline to 4 months were observed for vitamin A, retinol-binding protein, transthyretin, beta-carotene, methylmalonic acid, homocysteine, choline, total osteocalcin, carboxylated and undercarboxylated osteocalcin, and folate. In contrast, significant between-group differences in changes were observed for flavin adenine dinucleotide (FAD), serum vitamin B12, holotranscobalamin, and the combined vitamin B12 status indicator (cB12) after adjustment. CONCLUSION: A multinutrient supplement containing 82 µg of vitamin B12 per day significantly positively affected vitamin B12 blood biomarkers in healthy vegans. REGISTRATION: This study was registered in the German Clinical Trials Register (DRKS00028151). © 2025. The Author(s).

06
CLINICAL STUDY The Cochrane database of systematic reviews (2025) PMID: 41123035 ↗
Riboflavin supplements for blood pressure lowering in adults.
Clinical Trial Synthesis 2025 Meta-Analysis published in The Cochrane database of systematic reviews involving n = 320 participants; statistical significance reported at p = 0.32 (MD -1.94). Key conclusion: There has been interest in riboflavin (vitamin B2) as a potential intervention to lower blood pressure, particularly for those with a common genetic polymorphism in the methylene tetrahydrofolate reductase enzyme (MTHFR).
View Original PubMed Abstract ↓

Update of doi: 10.1002/14651858.CD015464. RATIONALE: Higher blood pressure is strongly related to an increased risk of cardiovascular disease. There has been interest in riboflavin (vitamin B2) as a potential intervention to lower blood pressure, particularly for those with a common genetic polymorphism in the methylene tetrahydrofolate reductase enzyme (MTHFR). OBJECTIVES: To assess the benefits and harms of riboflavin supplements compared to placebo or no additional treatment for lowering systolic and diastolic blood pressure. SEARCH METHODS: We searched the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, Clarivate Web of Science, Clarivate Food Science & Technology Abstracts and two clinical trials registries. There were no restrictions on language, publication year, or publication status. The latest search date was 24 October 2024. We also handsearched the reference lists of included studies. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) conducted in adults that evaluated oral riboflavin supplements compared with an inactive control (e.g. placebo or no additional treatment) and measured at least one of the critical outcomes. We did not include trials that evaluated multivitamins containing riboflavin. Participants in both the intervention and control groups were able to receive standard medical therapy for hypertension prior to and during the trial. OUTCOMES: The critical outcomes were systolic blood pressure and diastolic blood pressure. The important outcomes were antihypertensive medication, adverse events and biomarkers of riboflavin status. RISK OF BIAS: We used the Cochrane RoB 2 tool to assess the risk of bias in included studies for the following outcomes: systolic blood pressure, diastolic blood pressure, antihypertensive medication and adverse events. SYNTHESIS METHODS: We used standard Cochrane methods. For the critical outcomes, which were continuous, we calculated mean differences (MD) and 95% confidence intervals (CIs). We used a fixed-effect meta-analysis to pool data for each outcome where possible. We conducted subgroup analyses, inc

07
RANDOMIZED TRIAL (RCT) JAMA network open (2025) PMID: 40996763 ↗
Antioxidant Treatment and the Chance to Conceive in Men Seeking Fertility Care: The SUMMER Randomized Clinical Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in JAMA network open involving n = 1,171 participants. Key conclusion: OBJECTIVE: To assess whether treatment of men seeking fertility care with an antioxidant supplement can improve semen quality and pregnancy rates compared with a placebo.
View Original PubMed Abstract ↓

IMPORTANCE: Treatments for men seeking fertility care are limited. Antioxidant supplements have been widely studied as a new treatment option, but these studies have had conflicting results. OBJECTIVE: To assess whether treatment of men seeking fertility care with an antioxidant supplement can improve semen quality and pregnancy rates compared with a placebo. DESIGN, SETTING, AND PARTICIPANTS: The SUMMER trial was a multicenter, double-blind, placebo-controlled randomized clinical trial conducted in 21 hospitals and private fertility clinics in the Netherlands. Male patients in these centers were enrolled between May 2018 and February 2024, and follow-up of the primary outcome was completed in December 2024. Eligible participants were men aged 18 to 50 years with female partners aged 18 to 43 years, who sought fertility care and were advised to undergo expectant management, treatment with intrauterine insemination, in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI). Couples treated with ovulation induction only or IVF for bilateral tubal pathology were excluded. The men were randomly assigned to receive an antioxidant supplement or a placebo. Intention-to-treat analysis was performed for all outcomes. INTERVENTIONS: The antioxidant supplement (Impryl) was a tablet to be taken daily for 6 months. It contained betaine (200 mg), L-cystine (200 mg), niacin (16 mg), zinc (10 mg), vitamin B6 (1.4 mg), vitamin B2 (1.4 mg), folic acid (400 µg), and vitamin B12 (2.5 µg). The placebo tablet and its packaging were identical to those of the antioxidant supplement. All participating couples received standard infertility care. MAIN OUTCOMES AND MEASURES: The primary outcome was ongoing pregnancy conceived within 6 months after randomization. Secondary outcomes included semen parameters, sperm DNA fragmentation, fertilization and embryo utilization rates after IVF or ICSI, biochemical and clinical pregnancy rates, first-trimester pregnancy loss, ectopic pregnancy rate, cumulative number of pregnancies, time to pregnancy, and adverse events. RESULTS: A total of 1171 men (median [IQR] age, 34 [31-38] years; female partners' median [IQR] age, 32 [30-35] year

08
RANDOMIZED TRIAL (RCT) Nutrients (2025) PMID: 40507089 ↗
Impact of Vitamin B1 and Vitamin B2 Supplementation on Anxiety, Stress, and Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrients involving n = 43 participants; statistical significance reported at p = 0.01. Key conclusion: Conclusions: The clinical trial findings demonstrated that while vitamin B1 and B2 supplements helped reduce stress, enhance sleep, and reduce sleepiness, they had no discernible impact on reducing anxiety.
View Original PubMed Abstract ↓

Background: Anxiety, stress, and sleep disturbances significantly affect overall health. Research suggests that vitamins B1 and B2 may play a role in mood regulation and neuroprotection. This study aimed to investigate the effects of vitamin B1 and B2 supplementation in alleviating anxiety and stress and improving sleep quality. Methods: This study was a parallel randomized, double-blind, placebo-controlled clinical trial. Participants (n = 43) were randomized to receive one of the following two interventions: 100 mg of vitamin B1 and 100 mg of vitamin B2 or placebo. Intervention outcomes were assessed at baseline and week four, including SAS (Self-Rating Anxiety Scale), PSS (Perceived Stress Scale), PSQI (Sleep Quality Index), ESS (Sleepiness Scale), and measurement of urinary vitamin B1 and B2 levels. Results: After four weeks, urinary vitamin B1 levels increased from 158 ± 108.9 ng to 1333.1 ± 1204.5 ng (p < 0.01), and urinary vitamin B2 levels increased from 308.0 ± 198.3 ng to 6123.2 ± 4847.2 ng in the supplement group (p < 0.01). The PSS scores decreased significantly in the supplement group from 21.5 ± 4.1 to 15.5 ± 4.5 (p < 0.05), while the placebo group showed a change from 20.3 ± 4.3 to 19.8 ± 5.5. Vitamins B1 and B2 did not have a significant effect on anxiety improvement (p > 0.05). The PSQI scores decreased in the supplement group from 8.0 ± 3.12 to 6.3 ± 2.0 (p < 0.05), while the placebo group worsened from 5.7 ± 2.7 to 7.4 ± 2.9. Meanwhile, the ESS scores in the supplement group decreased from 13.0 ± 3.4 to 9.1 ± 3.9 (p < 0.05), demonstrating a significant improvement compared to the placebo group. Conclusions: The clinical trial findings demonstrated that while vitamin B1 and B2 supplements helped reduce stress, enhance sleep, and reduce sleepiness, they had no discernible impact on reducing anxiety. Future studies should focus on the long-term effects of vitamin B1 and B2 supplements, exploring the combined effects of combined vitamin B1 and B2 medications for the treatment of stress and sleep disorders.

09
RANDOMIZED TRIAL (RCT) Heliyon (2025) PMID: 40083990 ↗
A randomized multi-arm open labelled comparative clinical trial report of Pankajakasthuri DiabetEaze powder, a novel polyherbal formulation on the nutritional management and glycemic control in type 2 diabetic and prediabetic patients.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Heliyon involving n = 189 participants. Key conclusion: Furthermore, overall QoL among the tested groups was also statistically significant.
View Original PubMed Abstract ↓

BACKGROUND AND AIMS: Recently Diabetes Mellitus (DM) has been associated with heightened susceptibility to malnutrition, suggesting that augmenting nutritional intake stands out as a potent therapeutic strategy for addressing malnutrition in individuals with DM. The aim of this clinical investigation was to evaluate the effect of DiabetEaze powder, a polyherbal nutritional formulation developed by us for nutritional management and glycaemic control, on patients with diabetic and prediabetic conditions. METHODS: A total of 143 type II diabetic (T2D) patients who were managing their diabetic condition through modern medicine, AYUSH medicine, lifestyle modification and 68 pre-diabetic patients, aged between 40 and 65 years, were randomly assigned into six groups: control, modern, AYUSH, lifestyle, prediabetic control and prediabetic trial. The treatment groups were administered 5 g of DiabetEaze powder two times a day after food for 6 months. Microminerals, vitamins, glycaemic parameters, Quality of Life (QoL), hematology, lipid profiles, Renal Function Test (RFT) and Liver Function Test (LFL) parameters, and electrolytes were evaluated at Day 0, Day 90, and Day 180. RESULTS: Out of 211 enrolled patients, 189 individuals successfully completed the entire 180-day duration of the study, indicating a retention rate of approximately 89.6 %. In our study, we observed a statistically significant elevation in the levels of vitamin D, B2, and B6 across all treatment groups. Besides, the treatment groups displayed a notable increase in zinc and manganese levels compared to the other minerals tested. Notably, the treatment groups demonstrated distinct mineral and vitamin profiles. In terms of metabolic markers, significant reductions in Fasting Blood Sugar (FBS)/Post Prandial Blood Sugar (PPBS) were observed across the modern, AYUSH, and lifestyle groups, while the modern group also showed a marked decrease in glycated haemoglobin (HbA1c) levels. Furthermore, overall QoL among the tested groups was also statistically significant. The consistent maintenance of normal LFT and RFT parameters and electrolyte levels across trial groups throughout the study duration indicates that

10
RANDOMIZED TRIAL (RCT) Nutrients (2025) PMID: 40005035 ↗
Evaluating the Efficacy of Probiotics on Disease Progression, Quality of Life, and Nutritional Status Among Patients with Crohn's Disease: A Multicenter, Randomized, Single-Blinded Controlled Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrients involving n = 10 participants; statistical significance reported at p = 0.01. Key conclusion: QOL improved significantly in the intervention group,
View Original PubMed Abstract ↓

BACKGROUND: There is growing interest in the role of gut microbiota in the pathophysiology of inflammatory bowel diseases (IBDs), including Crohn's disease (CD). Probiotics have been proposed as a potential adjunct therapy for these conditions by altering the intestinal environment, although studies on their effectiveness have yielded mixed results. AIM: This study aims to evaluate the short-term (2 months) effects of a dietary supplement containing Lactobacilli, Bifidobacteria, and Lactococcus bacillus on disease progression, remission, quality of life, and nutritional intake in Lebanese patients with CD. METHOD: A multicenter, randomized, single-blind controlled trial was conducted in 2 medical centers in Beirut from 1 April 2024 to 1 August 2024. Recruitment, prescreening, screening, enrollment, and protocol implementation were carried out at both centers. Data were collected from 21 patients with CD, who were randomly assigned to the control group (n = 10) and the intervention group (n = 11). At baseline and after two months, participants underwent clinical assessments, WHOQOL-BREF evaluation, and 24 h dietary recalls. Follow-up visits included surveys on disease progression, quality of life, adherence, and adverse events, along with repeat body composition and anthropometric measurements. RESULTS: Probiotic supplementation over two months did not significantly alter symptoms, flares, or hospitalizations outcomes between the control and intervention groups. However, the intervention group experienced notable increases in body weight (p = 0.01), BMI (p = 0.01), body fat mass (p = 0.04), and arm muscle circumference (p = 0.01). Nutrient intake patterns differed, with the intervention group showing increased consumption of calcium, riboflavin, and folate compared to controls (p = 0.01, p = 0.04, p = 0.013, respectively). Probiotic supplementation led to significant within-group increases in dietary fiber (p = 0.01), total sugar (p = 0.02), and caffeine (p = 0.01) among the intervention participants. Adverse effects in the intervention group were mild, including nausea (18.2%) and abdominal discomfort (9.1%). QOL improved significantly in the intervention group,

RELATED MONOGRAPHS

Related Monographs in This Category