The Effects of Flaxseed Oil Omega-3 Fatty Acids Supplementation on Metabolic Status of Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Mirmasoumi, Golara; Fazilati, Mohammad; Foroozanfard, Fatemeh; Vahedpoor, Zahra; Mahmoodi, Samaneh; Taghizadeh, Mohsen; Esfeh, Nazanin Kazemi; Mohseni, Maryam; Karbassizadeh, Hassan; Asemi, Zatollah

doi:10.1055/s-0043-119751

Cited by 44 publications

(64 citation statements)

References 37 publications

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“…Of the 80 trials identified that used mineral oil, 16 reported high-sensitivity C-reactive protein (hsCRP) levels ranging from −15.9% to +33.3%; levels were increased in 10 studies, 8 , 40 , 42 , 53 , 55 , 56 , 62–64 decreased in 5 studies, 47 , 50 , 61 , 65 , 66 and unchanged in 1 study. 67 As with lipid parameters, most changes were inconsistent and not reported as statistically significant.…”

Section: Resultsmentioning

confidence: 99%

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Olshansky

Chung

Budoff³

et al. 2020

European Heart Journal Supplements

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Mineral oil is often used as a clinical trial placebo. Pharmaceutical-grade mineral oil consists of a mixture of saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils. Interest in mineral oil was piqued by suggestions that a portion of the substantially positive results of the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) might be attributable to the theoretical negative effects of mineral oil rather than being due to the clinical benefits of icosapent ethyl. The objective of this review was to explore possible mineral oil safety and efficacy effects and contextualize these findings in light of the REDUCE-IT conclusions. A literature search identified studies employing mineral oil placebos. Eighty studies were identified and relevant data extracted. Adverse events associated with mineral oil were generally gastrointestinal and consistent with use as a lubricant laxative. Changes in triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, high-sensitivity C-reactive protein, and other biomarkers were inconsistent and generally not statistically significant, or clinically meaningful with mineral oil, as were changes in blood pressure. There was no consistent evidence that mineral oil in the amounts used in the REDUCE-IT or Effect of Vascepa on Progression of Coronary Atherosclerosis in Patients With Elevated Triglycerides on Statin Therapy (EVAPORATE) trials affects absorption of essential nutrients or drugs, including statins. These results were then considered alongside publicly available data from REDUCE-IT. Based on available evidence, mineral oil does not appear to impact medication absorption or efficacy, or related clinical outcomes, and, therefore, does not meaningfully affect study conclusions when used as a placebo at the quantities used in clinical trials.

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Section: Resultsmentioning

confidence: 99%

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Olshansky

Chung

Budoff³

et al. 2020

European Heart Journal Supplements

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“…Serum insulin concentration was determined by using ELISA kits (Dia plus, Canada) with inter-and intraassay CVs of less than 12% and less than 10%, respectively. IR was determined by HOMA-IR using the following formula: HOMA-IR = [fasting insulin (mU/L) × fasting blood glucose (mg/dL)] / 405 [1]. Insulin sensitivity was also calculated by QUICKI equation: QUICKI = 1 / [log (fasting insulin, lU/mL) + log (fasting glucose, mg/ dL)] [1].…”

Section: Biochemical Analysismentioning

confidence: 99%

“…IR was determined by HOMA-IR using the following formula: HOMA-IR = [fasting insulin (mU/L) × fasting blood glucose (mg/dL)] / 405 [1]. Insulin sensitivity was also calculated by QUICKI equation: QUICKI = 1 / [log (fasting insulin, lU/mL) + log (fasting glucose, mg/ dL)] [1]. Serum total testosterone with inter-and intraassay CVs of 9.7 and 4.8% was determined by using direct immunoenzymatic assay (Accu Bind, USA).…”

Section: Biochemical Analysismentioning

confidence: 99%

“…Polycystic Ovary Syndrome (PCOS) is known as the most common endocrine disorder of women in reproductive ages, with the prevalence ranging from 6 to 15% [1,2]. The most common clinical manifestations of this syndrome include irregular menstrual cycles, infertility, acne, hair loss with the male pattern, Insulin Resistance (IR), and obesity [3,4].…”

Section: Introductionmentioning

confidence: 99%

“…Patients with PCOS are at increased risk for the development of metabolic syndrome, type II diabetes mellitus, and Cardiovascular Disease (CVD) [1,[6][7][8]. Although the main mechanism leading to PCOS remains unknown, obesity and IR seem to play a key role in the pathogenesis of this syndrome [9].…”

Section: Introductionmentioning

confidence: 99%

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The effects of flaxseed supplementation on metabolic status in women with polycystic ovary syndrome: a randomized open-labeled controlled clinical trial

Haidari

Banaei-Jahromi

Zakerkish

et al. 2020

Nutr J

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Background: Polycystic Ovary Syndrome (PCOS) is known as the most common endocrine disorder of women in reproductive ages. With the increasing prevalence of PCOS in different countries, the use of herbal medicine as an alternative treatment is growing in these patients. This study aimed to evaluate the effects of flaxseed powder supplementation on metabolic biomarkers of patients with PCOS. Methods: This randomized open-labeled controlled clinical trial was conducted on 41 patients with PCOS. The participants were randomized to take either flaxseed powder (30 g/day) plus lifestyle modification or only lifestyle modification for 12 weeks. Anthropometric and biochemical evaluations were performed for all patients at the beginning and end of the study. Results: The flaxseed group showed a significant reduction in body weight, insulin concentration, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Triglycerides (TG), high-sensitivity C-Reactive Protein (hs-CRP), and leptin and an increase in Quantitative Insulin-Sensitivity Check Index (QUICKI), High Density Lipoprotein (HDL), and adiponectin compared to the baseline (p < 0.05). Flaxseed supplementation also led to a significant reduction in insulin concentration, HOMA-IR, TG, hs-CRP, Interleukin 6 (IL-6), and leptin and an increase in QUICKI, HDL, and adiponectin compared to the control group (p < 0.05). No significant changes were observed in other parameters. Conclusions: Flaxseed supplementation plus lifestyle modification was more effective compared to lifestyle modification alone in biochemical and anthropometric variables in patients with PCOS. Trial registration: The trial protocol was approved by the Ethics Board at Ahvaz Jundishapur University of Medical Sciences and was registered at Iranian Registry of Clinical Trials (code: IRCT20120704010181N11).

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The effects of flaxseed or its oil supplementations on polycystic ovary syndrome: A systematic review of clinical trials

Emamat

Boushehri

Eslami

et al. 2022

Phytotherapy Research

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Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders around the world that can endanger reproductive, metabolic, and psychological health in women. Flaxseed is considered as a functional food which provides remarkable amounts of α‐linolenic acid (ALA), phytosterogenic lignans, and dietary fibers. This study aimed to investigate the effectiveness of flaxseed or its oil supplementation on PCOS patients. We systematically searched all published randomized clinical trials indexed in PubMed, Scopus, and Google Scholar databases from inception up to May 2022. Intended exposure and outcome were flaxseed or its oil and metabolic, anthropometric, and hormonal status of women with PCOS, respectively. Initial search via related keywords revealed 69 articles. After excluding duplicates, title and abstract of 55 remaining papers were screened. Fourteen papers were obtained for full text screening. Finally, nine clinical trials published between 2011 and 2021 were included in qualitative synthesis. Based on the results of the present systematic review, we suggest that flaxseed supplementation has the potential to improve metabolic, hormonal, and anthropometric parameters in women with PCOS. However, we also deduce that due to the scarcity of high‐quality studies, additional studies need to be conducted in order to derive a solid conclusion.

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The Effects of Flaxseed Oil Omega-3 Fatty Acids Supplementation on Metabolic Status of Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract: Overall, flaxseed oil omega-3 supplementation for 12 weeks in women with PCOS had beneficial effects on insulin metabolism, mF-G scores, serum triglycerides, VLDL-cholesterol and hs-CRP levels, but did not affect hormonal and other lipid profiles, and plasma nitric oxide levels.

Cited by 44 publications

References 37 publications

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

The effects of flaxseed supplementation on metabolic status in women with polycystic ovary syndrome: a randomized open-labeled controlled clinical trial

The effects of flaxseed or its oil supplementations on polycystic ovary syndrome: A systematic review of clinical trials

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