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NCT Number: NCT07322120

Light Fasting Diet and Magnesium in Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age, which is associated with hormonal imbalances, dyslipidemia, chronic inflammation, and increased oxidative stress, and can increase the risk of cardiovascular and metabolic diseases. Evidence suggests that nutritional interventions play an important role in improving metabolic outcomes in these patients.

This study is a randomized, triple-blind, controlled clinical trial designed to investigate the effect of a light fasting diet combined with magnesium supplementation on lipid profile, lipid peroxidation (malondialdehyde), and C-reactive protein (CRP) levels in women with PCOS. In this study, 46 eligible women were randomly divided into two groups receiving a light fasting diet with magnesium supplementation or placebo, and changes in biochemical and anthropometric indices were evaluated before and after 8 weeks of intervention.

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Key information

About this study

Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders in women of reproductive age, with a significant prevalence worldwide and in the Iranian female population. This syndrome is characterized by a set of hormonal and metabolic abnormalities, including hyperandrogenism, impaired ovulation, dyslipidemia, insulin resistance, mild chronic inflammation, and increased oxidative stress. Evidence suggests that women with Polycystic ovary syndrome (PCOS) have higher levels of inflammatory markers such as C-reactive protein (CRP) and lipid peroxidation indices such as malondialdehyde (MDA), and as a result, are at higher risk for cardiovascular and metabolic diseases. Currently, lifestyle modification including nutritional interventions and physical activity is recommended as the first line of treatment for Polycystic ovary syndrome (PCOS). Meanwhile, intermittent fasting-based diets, especially light fasting, have been proposed as a novel and sustainable approach that can improve lipid metabolism, reduce inflammation, and modulate oxidative stress without severe calorie restriction. On the other hand, magnesium, as an essential micronutrient, plays an important role in regulating glucose and lipid metabolism, increasing insulin sensitivity, reducing inflammation, and inhibiting oxidative processes. However, the evidence regarding the simultaneous effect of light fasting and magnesium supplementation on inflammatory markers and oxidative stress in women with Polycystic ovary syndrome (PCOS) is limited.

The present study is a randomized, triple-blind, controlled clinical trial designed to investigate the effect of light fasting combined with magnesium supplementation on lipid profile, lipid peroxidation, and C-reactive protein (CRP) levels in women with Polycystic ovary syndrome (PCOS). The study population includes women aged 19 to 65 years with Polycystic ovary syndrome (PCOS) with a body mass index equal to or higher than 25 kg/m2, diagnosed by a specialist based on the Rotterdam criteria. After obtaining informed consent, participants will be randomly divided into two groups. The intervention group will receive a light fasting diet with magnesium supplementation (500 mg/day in two doses of 250 mg), while the control group will receive the same light fasting diet with placebo. The nutritional intervention consists of a four-week cyclical program of light fasting designed to gradually adapt the body, and in the second month of the study, a diet with energy intake proportional to daily needs will be implemented to assess the sustainability of metabolic effects.

At the beginning of the study and after the end of the intervention period (8 weeks), anthropometric indicators including weight, Body mass index (BMI), and waist circumference will be measured. Physical activity was also assessed using the standard short-International physical activity questionnaire (IPAQ) and dietary intake was assessed using a three-day 24-hour food recall. Blood samples were collected after 12 to 14 hours of fasting and biochemical markers including total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, malondialdehyde (MDA), C-reactive protein (CRP), and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) were measured using standard laboratory methods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People between the ages of 19 and 65
  • People with a body mass index (BMI) ≤ 25
  • Diagnosis of polycystic ovary syndrome by a specialist based on the Rotterdam criteria

Exclusion criteria

  • Failure of the participant to cooperate during the study
  • Use of drug therapy that affects carbohydrate or fat metabolism (including oral contraceptives, insulin sensitizers, antiepileptic drugs, antipsychotics, statins, and fish oil) within the past 6 months.
  • Planning for pregnancy, pregnant, or breastfeeding
  • In the perimenopausal stage
  • Low blood pressure
  • Presence of other diseases (such as congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid disease, severe cardiovascular, gastrointestinal, renal, and hepatic diseases)
  • Performing high-intensity exercise

Treatment and study plan

Light fasting

Behavioral

Participants follow a Light Fasting diet during the first month, designed with gradual caloric restriction and intermittent fasting days, followed by a maintenance diet tailored to individual needs during the second month.

Magnesium Supplementation

Dietary Supplement

Participants receive magnesium supplementation (500 mg/day in two doses of 250 mg), for the full 2-month intervention.

Placebo

Dietary Supplement

Participants receive a placebo supplement identical in appearance to the magnesium tablets, taken twice daily, for the full 2-month intervention.

Primary outcomes

  1. Change from Baseline of total cholesterol

    Time frame: Baseline and 8 weeks after

    Serum TC (total cholesterol) concentration (mg/dl)

Secondary outcomes

  1. Change from baseline of Triglyceride

    Time frame: Baseline and 8 weeks after

    Serum TG (triacylglycerol) concentration (mg/dl)

  2. Change from baseline of low density lipoprotein cholesterol (LDL-Cholesterol)

    Time frame: Baseline and 8 weeks after

    Serum LDL concentration (mg/dl)

  3. Change from baseline of high density lipoprotein cholesterol (HDL-Cholesterol)

    Time frame: Baseline and 8 weeks after

    Serum HDL concentration (mg/dl)

  4. Change from baseline of Lipid Peroxidation

    Time frame: Baseline and 8 weeks after

    Changes in serum levels of lipid peroxidation markers (e.g., MDA)

  5. CRP

    Time frame: Baseline and 8 weeks after

    Changes in serum levels of C-reactive protein (CRP)

Sponsors and collaborators

Lead sponsor

Behnood Abbasi

Other

Registry information

Official study title

Investigation of the Effect of Light Fasting Diet Combined With Magnesium Supplementation on Lipid Profile, Lipid Peroxidation, and C-Reactive Protein (CRP) Levels in Women With Polycystic Ovary Syndrome (PCOS).

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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