NICEVIVA
MONOGRAPH SPEC LATEST 2022

Wheat Germ Oil

OTHER · Evidence Monograph

Wheat Germ Oil is an evidence-graded other monograph evaluated across 16 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials, encompassing n = 162 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 16 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (8 Double-Blind)
Cumulative Participants n = 162
Reported Trial Dosages 10 g · 23.7 µg · 22.9 µg
Trial Duration Range 6 weeks · 12 months · 4 months
Reading Time ~8 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 16 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (10 g · 23.7 µg · 22.9 µg) over a structured 6 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
With Breakfast or Lunch
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary other clinical efficacy (16 PubMed studies)
Quantitative biomarker & outcome analysis (11 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 8 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 0 reviews)
01

What Is Wheat Germ Oil & Why Does Form Matter?

Wheat Germ Oil is classified under OTHER and has been investigated across 16 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

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, 23.7 µg, 22.9 µg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Wheat Germ Oil 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, Wheat Germ Oil acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Wheat Germ Oil an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 16 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials (8 double-blind, n = 162 total participants).

Representative peer-reviewed findings include: • PMID:35406010 (2022) — "Effect of Vitamin D and Docosahexaenoic Acid Co-Supplementation on Vitamin D Status, Body Composition, and Metabolic Markers in Obese Children: A Randomized, Double Blind, Controlled Study." (De Cosmi V(1), Mazzocchi A(1), D'Oria V(2),) • PMID:35220442 (2022) — "UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D(2) without improving overall vitamin D status: a randomized controlled trial." (CONCLUSION: UVB-exposed WGO containing 23.7 µg vitamin D can increase 25(OH)D2 levels but do no improve total serum levels of 25(OH)D of vitamin D-insufficient subjects.) • PMID:11505860 (2001) — "Alternative medicine. Achieving balance between herbal remedies and medical therapy." (The patient continued taking valproate, 125 mg bid, which reduced her physical aggression and improved resistance to care.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 10 g · 23.7 µg · 22.9 µg · 125 mg over 6 weeks · 12 months · 4 months · 8 weeks. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Wheat Germ Oil, 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 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (10 g · 23.7 µg · 22.9 µg) and re-evaluate efficacy after 6 weeks.
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 (16 Studies) · 11 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) Nutrients (2022) PMID: 35406010 ↗
Effect of Vitamin D and Docosahexaenoic Acid Co-Supplementation on Vitamin D Status, Body Composition, and Metabolic Markers in Obese Children: A Randomized, Double Blind, Controlled Study.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Nutrients. Key conclusion: De Cosmi V(1), Mazzocchi A(1), D'Oria V(2),
View Original PubMed Abstract ↓

1. Nutrients. 2022 Mar 27;14(7):1397. doi: 10.3390/nu14071397. Effect of Vitamin D and Docosahexaenoic Acid Co-Supplementation on Vitamin D Status, Body Composition, and Metabolic Markers in Obese Children: A Randomized, Double Blind, Controlled Study. De Cosmi V(1), Mazzocchi A(1), D'Oria V(2),

02
RANDOMIZED TRIAL (RCT) European journal of nutrition (2022) PMID: 35220442 ↗
UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D(2) without improving overall vitamin D status: a randomized controlled trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in European journal of nutrition involving n = 14 participants. Key conclusion: CONCLUSION: UVB-exposed WGO containing 23.7 µg vitamin D can increase 25(OH)D2 levels but do no improve total serum levels of 25(OH)D of vitamin D-insufficient subjects.
View Original PubMed Abstract ↓

PURPOSE: This study investigated whether UVB-exposed wheat germ oil (WGO) is capable to improving the vitamin D status in healthy volunteers. METHODS: A randomized controlled human-intervention trial in parallel design was conducted in Jena (Germany) between February and April. Ultimately, 46 healthy males and females with low mean 25-hydroxyvitamin D (25(OH)D) levels (34.9 ± 10.6 nmol/L) were randomized into three groups receiving either no WGO oil (control, n = 14), 10 g non-exposed WGO per day (- UVB WGO, n = 16) or 10 g WGO, which was exposed for 10 min to ultraviolet B-light (UVB, intensity 500-630 µW/cm2) and provided 23.7 µg vitamin D (22.9 µg vitamin D2 and 0.89 µg vitamin D3) (+ UVB WGO, n = 16) for 6 weeks. Blood was obtained at baseline, after 3 and 6 weeks and analyzed for serum vitamin D-metabolite concentrations via LC-MS/MS. RESULTS: Participants who received the UVB-exposed WGO were characterized by an increase of circulating 25(OH)D2 after 3 and 6 weeks of intervention. However, the 25(OH)D3 concentrations decreased in the + UVB WGO group, while they increased in the control groups. Finally, the total 25(OH)D concentration (25(OH)D2 + 25(OH)D3) in the + UVB WGO group was lower than that of the non-WGO receiving control group after 6 weeks of treatment. In contrast, circulating vitamin D (vitamin D2 + vitamin D3) was higher in the + UVB WGO group than in the control group receiving no WGO. CONCLUSION: UVB-exposed WGO containing 23.7 µg vitamin D can increase 25(OH)D2 levels but do no improve total serum levels of 25(OH)D of vitamin D-insufficient subjects. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03499327 (registered, April 13, 2018). © 2022. The Author(s).

03
CLINICAL STUDY Geriatrics (2001) PMID: 11505860 ↗
Alternative medicine. Achieving balance between herbal remedies and medical therapy.
Clinical Trial Synthesis 2001 Clinical Study published in Geriatrics. Key conclusion: The patient continued taking valproate, 125 mg bid, which reduced her physical aggression and improved resistance to care.
View Original PubMed Abstract ↓

The case patient was taking multiple herbal preparations as well as the prescription hypnotic zolpidem. The combination was probably increasing the patient's confusion, agitation, and aggression. The treatment team reached a compromise with the daughter after providing her with education and support. They continued the wheat germ oil and a multivitamin supplement, which appeared safe, even if of limited value. The patient continued taking valproate, 125 mg bid, which reduced her physical aggression and improved resistance to care. All other herbal remedies and zolpidem were discontinued. Balancing traditional therapies with requests for herbal remedies is a common challenge for physicians. The most successful intervention occurs when doctors familiarize themselves with herbal preparations and educate patients and families about the treatments.

04
CLINICAL STUDY Brazilian journal of biology = Revista brasleira de biologia (2021) PMID: 34550291 ↗
The use of babosa (Aloe vera) in treating burns: a literature review.
Clinical Trial Synthesis 2021 Systematic Review published in Brazilian journal of biology = Revista brasleira de biologia involving n = 50 participants. Key conclusion: And the 6-month concentrated extract of 0.25 mg / mL had a higher content of flavonoids (9.750 mg catechin equivalent / g extract) and polyphenols (23.375 mg gallic acid equivalent / g extract) and the greater ferric reducing antioxidant power (0.047 mM equivalent ferrous sulfate
View Original PubMed Abstract ↓

Alo vera is a centenary remedy use for minor wounds and burns, but its mechanism of wound healing has not been know since. This article will evaluate and gather evidence of the effectiveness and safety of the use of aloe vera in the treatment of burns. A systematic review was carried out on the databases: MEDLINE, LILACS, DECS, SCIELO, in the last 7 years, with the descriptors: "Aloe", "Burns" and "treatment". 16 articles were found. After using the exclusion criteria; research in non-humans and literature review; 5 articles were selected. The article Teplick et al. (2018) performed an in vitro clinical experiment in A. Vera solution, and demonstrated that there was proliferation and cell migration of human skin fibroblasts and keratinocytes, in addition to being protective in the death of keratonocytes. That is, it accelerates the healing of wounds. Muangman et al. (2016), evaluated 50 patients with 20% of the total body surface area burned with second-degree burns, between 18-60 years old, with half of the group receiving gauze dressings with soft paraffin containing 0.5% chlorhexidine acetate and the other half receiving polyester dressings containing extracts of medicinal plants mainly Aloe Vera. It had positive results, a higher healing speed and shorter hospital stay compared to the control group. Hwang et al. (2015) investigated the antioxidant effects of different extracts from 2,4,6,8,12 months of Aloe Vera. And the 6-month concentrated extract of 0.25 mg / mL had a higher content of flavonoids (9.750 mg catechin equivalent / g extract) and polyphenols (23.375 mg gallic acid equivalent / g extract) and the greater ferric reducing antioxidant power (0.047 mM equivalent ferrous sulfate / mg extract), that is, greater potential for free radical scavenging and also a protective effect against oxidative stress induced by tert-butyl hydroperoxide (t-BHP), suggesting evidence of a bioactive potential of A. vera . However, in the article Kolacz et al. (2014) suggested as an alternative treatment the use of Aloe Vera dressing in combination with honey, lanolin, olive oil, wheat germ oil, marshmallow root, wormwood, comfrey root, white oak bark, lobelia inflata,

05
RANDOMIZED TRIAL (RCT) Nutrients (2021) PMID: 33572368 ↗
Effect of Omega-3 Supplementation in Pregnant Women with Obesity on Newborn Body Composition, Growth and Length of Gestation: A Randomized Controlled Pilot Study.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in Nutrients; statistical significance reported at p = 0.02. Key conclusion: Supplementation with n-3 PUFA in women with OWOB led to higher lean mass accrual at birth as well as improved fetal growth and longer gestation.
View Original PubMed Abstract ↓

Maternal obesity, a state of chronic low-grade metabolic inflammation, is a growing health burden associated with offspring adiposity, abnormal fetal growth and prematurity, which are all linked to adverse offspring cardiometabolic health. Higher intake of anti-inflammatory omega-3 (n-3) polyunsaturated fatty acids (PUFA) in pregnancy has been associated with lower adiposity, higher birthweight and longer gestation. However, the effects of n-3 supplementation specifically in pregnant women with overweight and obesity (OWOB) have not been explored. We conducted a pilot double-blind randomized controlled trial of 72 pregnant women with first trimester body mass index (BMI) ≥ 25 kg/m2 to explore preliminary efficacy of n-3 supplementation. Participants were randomized to daily DHA plus EPA (2 g/d) or placebo (wheat germ oil) from 10-16 weeks gestation to delivery. Neonatal body composition, fetal growth and length of gestation were assessed. For the 48 dyads with outcome data, median (IQR) maternal BMI was 30.2 (28.2, 35.4) kg/m2. In sex-adjusted analyses, n-3 supplementation was associated with higher neonatal fat-free mass (β: 218 g; 95% CI 49, 387) but not with % body fat or fat mass. Birthweight for gestational age z-score (-0.17 ± 0.67 vs. -0.61 ± 0.61 SD unit, p = 0.02) was higher, and gestation longer (40 (38.5, 40.1) vs. 39 (38, 39.4) weeks, p = 0.02), in the treatment vs. placebo group. Supplementation with n-3 PUFA in women with OWOB led to higher lean mass accrual at birth as well as improved fetal growth and longer gestation. Larger well-powered trials of n-3 PUFA supplementation specifically in pregnant women with OWOB should be conducted to confirm these findings and explore the long-term impact on offspring obesity and cardiometabolic health.

06
CLINICAL STUDY International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition (2021) PMID: 31433269 ↗
Fish oil plus wheat germ oil have no prominent effect on homocysteine levels and nutritional indices in hemodialysis patients.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition; statistical significance reported at p = 0.05. Key conclusion: Conclusions: Fish oil and wheat germ oil combination did not produce significant effects on serum homocysteine levels and nutritional indices of hemodialysis patients.
View Original PubMed Abstract ↓

Background: Elevated homocysteine levels and malnutrition are frequently detected in hemodialysis patients and are believed to exacerbate cardiovascular comorbidities. Omega-3 fatty acids have been postulated to lower homocysteine levels by up-regulating metabolic enzymes and improving substrate availability for homocysteine degradation. Additionally, it has been suggested that prevention of folate depletion by vitamin E consumption decreases homocysteine levels. However, data on the effect of omega-3 fatty acids and/or vitamin E on homocysteine levels and nutritional status have been inconclusive. Therefore, this study was planned to examine the effect of combined supplementation of fish oil, as a source of omega-3 fatty acids, with wheat germ oil, as a source of vitamin E, on homocysteine and nutritional indices in hemodialysis patients. Methods: This study was a randomized, double-blind, placebo-controlled trial. Forty-six hemodialysis patients were randomly assigned to two equally-sized groups; a supplemented group who received 3000 mg/day of fish oil [1053 mg omega-3 fatty acids] plus 300 mg/day of wheat germ oil [0.765 mg vitamin E], and a matched placebo group who received placebo capsules for 4 months. Serum homocysteine and different nutritional indices were measured before and after the intervention. Results: Twenty patients in each group completed the study. At the end of the study, there were no significant changes in homocysteine levels and in the nutritional indices neither in the supplemented nor in the placebo-control groups (p > 0.05). Conclusions: Fish oil and wheat germ oil combination did not produce significant effects on serum homocysteine levels and nutritional indices of hemodialysis patients.

07
RANDOMIZED TRIAL (RCT) Minerva medica (2018) PMID: 30221912 ↗
Beneficial effects of probiotic combination with omega-3 fatty acids in NAFLD: a randomized clinical study.
Clinical Trial Synthesis 2018 Randomized Controlled Trial (RCT) published in Minerva medica involving n = 48 participants; statistical significance reported at p = 0.001. Key conclusion: CONCLUSIONS: Coadministration of a live multi-strain probiotic mixture with omega-3 fatty acids once daily for 8 weeks to patients with NAFLD can reduce liver fat, improve serum lipids, metabolic profile, and reduce chronic systemic inflammatory state.
View Original PubMed Abstract ↓

BACKGROUND: The manipulation of gut microbiota via administration of probiotics has been proposed as a potential strategy for the treatment of non-alcoholic fatty liver disease (NAFLD). Hence, we performed a double-blind single center randomized placebo-controlled trial (RCT) to evaluate the efficacy of coadministration of probiotics with omega-3 vs. placebo in type-2 diabetic patients with NAFLD. METHODS: A total of 48 patients met the criteria for inclusion. They were randomly assigned to receive "Symbiter Omega" combination of probiotic biomass supplemented with flax and wheat germ oil (250 mg of each, concentration of omega-3 fatty acids 1-5%) or placebo for 8-weeks. The primary main outcomes were the change in fatty liver index (FLI) and liver stiffness (LS) measured by Shear Wave Elastography (SWE). Secondary outcomes were the changes in transaminases level, serum lipids and cytokines levels. RESULTS: In probiotic-omega group, FLI significantly decreased from 83.53±2.60 to 76.26±2.96 (P<0.001) while no significant changes were observed in the placebo group (82.86±2.45 to 81.09±2.84; P=0.156). Changes of LS in both groups were insignificant. Analysis of secondary outcomes showed that the coadministration of probiotics with omega-3 lead to significant reduction of serum gamma-glutamyl transpeptidase, triglycerides, and total cholesterol. Chronic systemic inflammatory markers after intervention decrease significantly only in Symbiter Omega group: IL-1β (P=0.029), TNF-α (P<0.001), IL-8 (P=0.029), IL-6 (P=0.003), and INF-γ (P=0.016). CONCLUSIONS: Coadministration of a live multi-strain probiotic mixture with omega-3 fatty acids once daily for 8 weeks to patients with NAFLD can reduce liver fat, improve serum lipids, metabolic profile, and reduce chronic systemic inflammatory state.

08
RANDOMIZED TRIAL (RCT) International urology and nephrology (2017) PMID: 28667579 ↗
The impact of fish oil and wheat germ oil combination on mineral-bone and inflammatory markers in maintenance hemodialysis patients: a randomized, double-blind, placebo-controlled clinical trial.
Clinical Trial Synthesis 2017 Randomized Controlled Trial (RCT) published in International urology and nephrology; statistical significance reported at p = 0.0016. Key conclusion: CONCLUSION: FO plus WGO supplementation showed beneficial effect on serum Ca levels of HD patients without any statistically significant effect on other mineral-bone and inflammatory markers.
View Original PubMed Abstract ↓

PURPOSE: This study aimed to examine the impact of combined supplementation of fish oil (FO) with antioxidants like wheat germ oil (WGO) on mineral-bone and inflammatory markers in maintenance HD patients. METHODS: This randomized, double-blind, placebo-controlled trial involved 46 HD patients who were randomly assigned into two groups to receive daily 3000 mg of FO [1053 mg omega-3 fatty acids (ω-3 FAs)] plus 300 mg of WGO [0.765 mg vitamin E] or placebo for 4 months. Blood concentrations of hemoglobin (Hgb), white blood cells, mineral-bone parameters including serum calcium (Ca), phosphorus, calcium-phosphorus product, parathyroid hormone, alkaline phosphatase, and osteoprotegerin and serum concentrations of inflammatory markers including high-sensitivity C-reactive protein, ferritin, and uric acid were measured before and after the intervention. RESULTS: Eighty-seven percentage of patients in each group completed the study. The mean serum Ca levels increased significantly in the supplemented group at the end of study (p = 0.0016), and this increment was also significant as compared to placebo group (p = 0.0418). No significant alterations were observed in the other measured parameters within each group during the study (as p values were >0.05). CONCLUSION: FO plus WGO supplementation showed beneficial effect on serum Ca levels of HD patients without any statistically significant effect on other mineral-bone and inflammatory markers. Further investigations are required to confirm it.

09
CLINICAL STUDY International journal of food sciences and nutrition (2014) PMID: 24228803 ↗
Blood lipids profile in hyperlipidemic children undergoing different dietary long chain polyunsaturated supplementations: a preliminary clinical trial.
Clinical Trial Synthesis 2014 Randomized Controlled Trial (RCT) published in International journal of food sciences and nutrition. Key conclusion: This preliminary study suggests powered trials appear feasible and are warranted to evaluate efficacy of n-3 long-chain polyunsaturated fatty acid dietary supplementations on the blood lipid profile of children with primary hyperlipidemia.
View Original PubMed Abstract ↓

The aim of this preliminary study was to explore the effect size of different dietary long chain polyunsaturated supplementations on blood lipid profile in children with primary hyperlipidemia. Thirty-six children (8-13 years) were recruited. After an 8-week stabilization period on the Step I diet, they were randomized to additionally receive for a 16-week period one capsule (500 mg) daily of docosahexaenoic acid (DHA) alone or a DHA plus eicosapentaenoic acid (EPA) mixture (45.6% DHA; 41.6% EPA) or wheat germ oil (control). An effect size (as percentage change from baseline) of +8%, -12% and -16% for high-density lipoprotein cholesterol (HDL-C), total cholesterol/HDL-C ratio and triglycerides was observed in children supplemented with DHA, compared to +2%, -8% and -12%, respectively, in children supplemented with DHA plus EPA. This preliminary study suggests powered trials appear feasible and are warranted to evaluate efficacy of n-3 long-chain polyunsaturated fatty acid dietary supplementations on the blood lipid profile of children with primary hyperlipidemia.

10
CLINICAL STUDY Climacteric (2011) PMID: 21545273 ↗
Improvement in HDL cholesterol in postmenopausal women supplemented with pumpkin seed oil: pilot study.
Clinical Trial Synthesis 2011 Randomized Controlled Trial (RCT) published in Climacteric involving n = 14 participants; statistical significance reported at p = 0.029. Key conclusion: CONCLUSION: This pilot study showed pumpkin seed oil had some benefits for postmenopausal women and provided strong evidence to support further studies.
View Original PubMed Abstract ↓

OBJECTIVE: Pumpkin seed oil is rich in phytoestrogens and animal studies suggest that there is some benefit to supplementation in low estrogen conditions. This study is the first to evaluate the benefit of pumpkin seed oil in postmenopausal women. METHODS: This pilot study was randomized, double-blinded and placebo-controlled. Study participants included 35 women who had undergone natural menopause or had iatrogenically entered the climacteric due to surgery for benign pathology. Wheat germ oil (placebo; n = 14) and pumpkin seed oil (n = 21) were administered to eligible participants over a 12-week period at a dose of 2 g per day. Serum lipids, fasting plasma glucose and blood pressure were measured and an 18-point questionnaire regarding menopausal symptoms was administered; the atherogenic index was also calculated. Differences between groups, as well as before and after the period of supplementation, were evaluated with Student's t-test, Wilcoxon matched-pair signed-ranked test and Mann-Whitney test, as appropriate (Stata version 10.1). RESULTS: Women receiving pumpkin seed oil showed a significant increase in high density lipoprotein cholesterol concentrations (0.92 ± 0.23 mmol/l vs. 1.07 ± 0.27 mmol/l; p = 0.029) and decrease in diastolic blood pressure (81.1 ± 7.94 mmHg vs. 75.67 ± 11.93 mmHg; p < 0.046). There was also a significant improvement in the menopausal symptom scores (18.1 ± 9.0 vs. 13.2 ± 6.7; p < 0.030), with a decrease in severity of hot flushes, less headaches and less joint pains being the main contributors. Women in the group receiving wheat germ oil reported being more depressed and having more unloved feeling. CONCLUSION: This pilot study showed pumpkin seed oil had some benefits for postmenopausal women and provided strong evidence to support further studies.

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