Light Fasting Diet and Magnesium in Polycystic Ovary Syndrome (PCOS)
ConditionPolycystic Ovary Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-65
SponsorBehnood Abbasi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Light fasting
BehavioralParticipants 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 supplementParticipants receive magnesium supplementation (500 mg/day in two doses of 250 mg), for the full 2-month intervention.
Light fasting
BehavioralParticipants 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.
Placebo
Dietary supplementParticipants receive a placebo supplement identical in appearance to the magnesium tablets, taken twice daily, for the full 2-month intervention.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Light fasting and Magnesium SupplementationExperimental treatment 2 interventions
Group B: Light fasting and PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline of total cholesterol
Serum TC (total cholesterol) concentration (mg/dl)
Time frame
Baseline and 8 weeks afterSecondary outcomes
1
Change from baseline of Triglyceride
Serum TG (triacylglycerol) concentration (mg/dl)
Time frame
Baseline and 8 weeks after2
Change from baseline of low density lipoprotein cholesterol (LDL-Cholesterol)
Serum LDL concentration (mg/dl)
Time frame
Baseline and 8 weeks after3
Change from baseline of high density lipoprotein cholesterol (HDL-Cholesterol)
Serum HDL concentration (mg/dl)
Time frame
Baseline and 8 weeks after4
Change from baseline of Lipid Peroxidation
Changes in serum levels of lipid peroxidation markers (e.g., MDA)
Time frame
Baseline and 8 weeks afterLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Behnood Abbasi
Lead sponsor
Science & Research Islamic Azad University Branch Khozestan
Sponsor institution
Source ClinicalTrials.gov
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