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

NCT07322120 | Not Yet Recruiting

• 1 other identifier: IR.IAU.SRB.REC.1404.308
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Light Fasting; Magnesium; Lipid Profile; Lipid Peroxidation; C-Reactive Protein

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of total cholesterol

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

  Baseline and 8 weeks after

Secondary Outcomes (5)

• Change from baseline of Triglyceride

  Baseline and 8 weeks after

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

  Baseline and 8 weeks after

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

  Baseline and 8 weeks after

• Change from baseline of Lipid Peroxidation

  Baseline and 8 weeks after

• CRP

  Baseline and 8 weeks after

Study Arms (2)

Light fasting and Magnesium Supplementation

EXPERIMENTAL

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

Behavioral: Light fasting; Dietary Supplement: Magnesium supplementation

Light fasting and Placebo

PLACEBO COMPARATOR

Participants follow the same Light Fasting and maintenance diet schedule as the intervention group and receive a placebo supplement identical in appearance to the magnesium tablets, taken twice daily, for the full 2-month intervention.

Behavioral: Light fasting; Dietary Supplement: Placebo

Interventions

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.

Light fasting and Magnesium Supplementation

Magnesium supplementation DIETARY_SUPPLEMENT

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

Light fasting and Magnesium Supplementation

Placebo DIETARY_SUPPLEMENT

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

Light fasting and Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Behnood Abbasi: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind study. Participants, investigators, and outcomes assessors are blinded to group allocation. Only the study coordinator has access to group assignments for safety purposes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty member

Model Details: Participants are randomly assigned to two parallel groups. Both groups follow a Light Fasting diet, but the intervention group receives magnesium supplementation, while the control group receives a placebo. The intervention lasts for 2 months, and primary outcomes include lipid profile, lipid peroxidation, and C-reactive protein (CRP) levels.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): June 22, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share