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Polycystic Ovary SyndromeNCT07322120

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

A study testing Light fasting and Magnesium supplementation in people with Polycystic Ovary Syndrome, run by Behnood Abbasi.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Light fasting and Magnesium supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
No sites listed yet
Study dates
20 Feb 2026to 22 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official 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).

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.

Being tested
Light fasting, Magnesium supplementation, Placebo
Keywords
Polycystic Ovary Syndrome, Light Fasting, Magnesium, Lipid Profile, Lipid Peroxidation, C-Reactive Protein
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Light fastingBehavioural

    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 supplementationDietary supplement

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

  • Light fastingBehavioural

    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.

  • PlaceboDietary supplement

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

Study groups in NCT07322120
Study groupRoleWhat they receive
Light fasting and Magnesium SupplementationExperimentalParticipants 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.
Receives: Behavioral: Light fasting; Dietary Supplement: Magnesium supplementation
Light fasting and PlaceboPlacebo comparatorParticipants 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.
Receives: Behavioral: Light fasting; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline of total cholesterol

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

    Measured: Baseline and 8 weeks after

Secondary outcomes (5)
  1. Change from baseline of Triglyceride

    Serum TG (triacylglycerol) concentration (mg/dl)

    Measured: Baseline and 8 weeks after

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

    Serum LDL concentration (mg/dl)

    Measured: Baseline and 8 weeks after

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

    Serum HDL concentration (mg/dl)

    Measured: Baseline and 8 weeks after

  4. Change from baseline of Lipid Peroxidation

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

    Measured: Baseline and 8 weeks after

  5. CRP

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

    Measured: Baseline and 8 weeks after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start20 Feb 2026 (estimated)
  3. Primary completion22 May 2026 (estimated)
  4. Study completion22 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07322120
Sponsor's protocol ID
IR.IAU.SRB.REC.1404.308
Status last verified
Dec 2025
First submitted
22 Dec 2025
Last updated
7 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Light fasting and Magnesium supplementation in people with Polycystic Ovary Syndrome, run by Behnood Abbasi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline of total cholesterol (time frame: Baseline and 8 weeks after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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