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Not yet recruitingNCT07322120Updated Jan 7, 2026

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

An interventional study of Light fasting and Magnesium supplementation in Polycystic Ovary Syndrome, sponsored by Behnood Abbasi. Not yet recruiting. Open to female participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Behnood Abbasi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic Ovary Syndrome
  • Light Fasting
  • Magnesium
  • Lipid Profile
  • Lipid Peroxidation
  • C-Reactive Protein
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 46 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Behnood Abbasi is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. People between the ages of 19 and 65
  2. People with a (BMI) ≤ 25
  3. Diagnosis of polycystic ovary syndrome by a specialist based on the Rotterdam criteria

Exclusion criteria

Exclusion Criteria:

  1. Failure of the participant to cooperate during the study
  2. Use of drug therapy that affects carbohydrate or fat metabolism (including oral , insulin sensitizers, antiepileptic drugs, antipsychotics, statins, and fish oil) within the past 6 months.
  3. Planning for pregnancy, pregnant, or breastfeeding
  4. In the perimenopausal stage
  5. Low blood pressure
  6. 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)
  7. Performing high-intensity exercise
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Light fasting and Magnesium Supplementation

    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

  • Placebo comparator
    Light fasting and Placebo

    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

  • BehavioralLight fasting

    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.

  • Dietary supplementMagnesium supplementation

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

  • BehavioralLight fasting

    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.

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change from Baseline of total cholesterol

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

    Time frame: Baseline and 8 weeks after

Secondary outcomes

  1. Change from baseline of Triglyceride

    Serum TG (triacylglycerol) concentration (mg/dl)

    Time frame: Baseline and 8 weeks after

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

    Serum LDL concentration (mg/dl)

    Time frame: Baseline and 8 weeks after

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

    Serum HDL concentration (mg/dl)

    Time frame: Baseline and 8 weeks after

  4. Change from baseline of Lipid Peroxidation

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

    Time frame: Baseline and 8 weeks after

  5. CRP

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

    Time frame: Baseline and 8 weeks after

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07322120
Lead sponsor
Behnood Abbasi
Responsible party
Behnood Abbasi (Faculty member, Science & Research Islamic Azad University Branch Khozestan) — Sponsor-investigator
First posted
Jan 7, 2026
Start date
Feb 20, 2026 (estimated)
Primary completion
May 22, 2026 (estimated)
Completion
Jun 22, 2026 (estimated)
Last update
Jan 7, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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