Polycystic Ovary SyndromeNCT06804044
Intermittent Fasting (IF) Has Gained Recognition as a Promising Weight Loss Approach That Improves Body Weight, Insulin Resistance, and Metabolism. While Standard Diets Are Common in PCOS Management, IF May Address the Underlying Causes of Weight Gain and Offer Additional Metabolic Benefits
A study testing Intermittent Fasting and Standart Diet Therapy in people with Polycystic Ovary Syndrome and Weight Loss, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if dietary interventions works to improve anthropometric measures in women with PCOS. The main questions it aims to answer are: Does intermittent fasting (IF) cause loss of body weight, fat and muscle mass? Can IF be considered more effective to medical and standart… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Weight Loss, Intermittent Fasting
- What is being tested?
- Intermittent Fasting and Standart Diet Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2022to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Voluntariness to participate in the study
- BMI between 25-35 kg/m2
- Women between the ages of 18-45
Who cannot join
- An endocrine disorder other than polycystic ovary syndrome
- Chronic liver and kidney disease,
- Diabetes,
- Hypertension,
- Hyperuricemia,
- Heart Failure,
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- Thyroid disease,
- Pregnant and breastfeeding women,
- Individuals with psychiatric disorders,
- Oncological diseases,
- Women using medication,
- Those with pacemakers and platinum,
- Those with special nutritional needs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahçeşehir University
Istanbul, Beşiktaş, 34353
About this study
Official title: Effects of Different Dietary Programs on Anthropometric Parameters in Women With Polycystic Ovary Syndrome
The goal of this clinical trial is to learn if dietary interventions works to improve anthropometric measures in women with PCOS. The main questions it aims to answer are:
- Does intermittent fasting (IF) cause loss of body weight, fat and muscle mass?
- Can IF be considered more effective to medical and standart nutrition therapy (SDT)?
- What dietary problems do participants have when having IF diet?
Participants will:
- Follow IF, SDT, or no intervention for 8 weeks.
- Visit the clinic once every 2 weeks for check ups with a total of 5 visits for intervention groups IF and STD, visit at the beginning, second week and at the end for control group
- Keep dietary records
Read the detailed description
It was conducted in individuals who were diagnosed with PCOS as a result of clinical, biochemical and ultrasonographic medical evaluation by a gynecologist.
- Conditions
- Polycystic Ovary Syndrome, Weight Loss, Intermittent Fasting, Medical Nutrition Therapy, Caloric Restriction
- Being tested
- Intermittent Fasting, Standart Diet Therapy
- Keywords
- Diet, PCOS, IF
- Medical subject headings
- Polycystic Ovary Syndrome, Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingBehavioural
A 16:8 intermittent fasting with a daytime eating window model was applied.
Standart Diet TherapyBehavioural
Meal plan with 3 main meals and 3 snacks was applied.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting Diet Therapy | Experimental | The dietary principles implemented for overweight/obese women with PCOS: targeting a 5% weight loss in line with the recommendations of the Turkish Endocrinology and Metabolism Association, calculating daily calorie requirements using the Harris-Benedict formula, and setting macronutrient distribution ratios to 45-60% carbohydrates, 15-20% protein, and 25-30% fat. Receives: Behavioral: Intermittent Fasting |
| Standart Diet Therapy | Experimental | The dietary principles implemented for overweight/obese women with PCOS: targeting a 5% weight loss in line with the recommendations of the Turkish Endocrinology and Metabolism Association, calculating daily calorie requirements using the Harris-Benedict formula, and setting macronutrient distribution ratios to 45-60% carbohydrates, 15-20% protein, and 25-30% fat. Receives: Behavioral: Standart Diet Therapy |
| Free of dietary intervention | No intervention | No dietary intervention was made and the individuals continued their current diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight lose
Total body weight (kg)
Measured: 8 weeks
Body Composition: Fat, Muscle
Body Muscle= skeletal muscle mass (kg), regional muscle analysis (right-left arm, trunk, right-left leg) (kg).
Body Fat= fat mass (kg), regional fat analysis (right-left arm, trunk, right-left leg) (kg).
Measured: 8 weeks
Body Circumference Measurements
Waist Circumference, Hip Circumference, Upper Arm Circumference, Neck Circumference
Measured: 8 weeks
Secondary outcomes (7)
Body Mass Indeks
weight (kg) and height (cm) will be combined to report BMI in kg/m^2
Measured: 8 weeks
Body Fat Ratio
total fat ratio (%)
Measured: 8 weeks
Body Water
Body water (ml)
Measured: 8 weeks
Dietary Energy Intakes
Energy (kcal),
Measured: 8 weeks
Energy Ratio from Macronutrients
Carbohydrate energy %, Protein energy % ,Fat energy %
Measured: 8 weeks
Dietary Macronutrients Intakes
Macronutrients: carbohydrates (g), proteins (g), fats (g)
Measured: 8 weeks
Dietary Micronutrients Intakes
Micronutrents: Vitamin and Mineral intakes will be presented as a percentage (%) of meeting the daily recommended intake.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start30 Nov 2022
- Primary completion30 May 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonca Sevim, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804044
- Sponsor's protocol ID
- 12309112022
- Status last verified
- Nov 2022
- First submitted
- 21 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Dietary Programs on Anthropometric Parameters in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06804044
- Acronym / sponsor ID
- 12309112022
- Conditions
- Polycystic Ovary Syndrome, Weight Loss, Intermittent Fasting, Medical Nutrition Therapy, Caloric Restriction
- Keywords
- Diet, PCOS, IF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if dietary interventions works to improve anthropometric measures in women with PCOS. The main questions it aims to answer are:
- Does intermittent fasting (IF) cause loss of body weight, fat and muscle mass?
- Can IF be considered more effective to medical and standart nutrition therapy (SDT)?
- What dietary problems do participants have when having IF diet?
Participants will:
- Follow IF, SDT, or no intervention for 8 weeks.
- Visit the clinic once every 2 weeks for check ups with a total of 5 visits for intervention groups IF and STD, visit at the beginning, second week and at the end for control group
- Keep dietary records
Detailed description
It was conducted in individuals who were diagnosed with PCOS as a result of clinical, biochemical and ultrasonographic medical evaluation by a gynecologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting Diet Therapy | Experimental | Behavioral: Intermittent FastingThe dietary principles implemented for overweight/obese women with PCOS: targeting a 5% weight loss in line with the recommendations of the Turkish Endocrinology and Metabolism Association, calculating daily calorie requirements using the Harris-Benedict formula, and setting macronutrient distribution ratios to 45-60% carbohydrates, 15-20% protein, and 25-30% fat. |
| Standart Diet Therapy | Experimental | Behavioral: Standart Diet TherapyThe dietary principles implemented for overweight/obese women with PCOS: targeting a 5% weight loss in line with the recommendations of the Turkish Endocrinology and Metabolism Association, calculating daily calorie requirements using the Harris-Benedict formula, and setting macronutrient distribution ratios to 45-60% carbohydrates, 15-20% protein, and 25-30% fat. |
| Free of dietary intervention | No intervention | –No dietary intervention was made and the individuals continued their current diet. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Voluntariness to participate in the study
- BMI between 25-35 kg/m2
- Women between the ages of 18-45
Key exclusion criteria (13 listed)
- An endocrine disorder other than polycystic ovary syndrome
- Chronic liver and kidney disease,
- Diabetes,
- Hypertension,
- Hyperuricemia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingA 16:8 intermittent fasting with a daytime eating window model was applied. | Behavioural | Intermittent Fasting Diet Therapy |
| Standart Diet TherapyMeal plan with 3 main meals and 3 snacks was applied. | Behavioural | Standart Diet Therapy |
Primary outcome
Body Weight lose
Time frame: 8 weeks
Total body weight (kg)
Body Composition: Fat, Muscle
Time frame: 8 weeks
Body Muscle= skeletal muscle mass (kg), regional muscle analysis (right-left arm, trunk, right-left leg) (kg). Body Fat= fat mass (kg), regional fat analysis (right-left arm, trunk, right-left leg) (kg).
Body Circumference Measurements
Time frame: 8 weeks
Waist Circumference, Hip Circumference, Upper Arm Circumference, Neck Circumference
7 secondary outcomes
Body Mass Indeks
Time frame: 8 weeks
Body Fat Ratio
Time frame: 8 weeks
Body Water
Time frame: 8 weeks
Dietary Energy Intakes
Time frame: 8 weeks
Energy Ratio from Macronutrients
Time frame: 8 weeks
Dietary Macronutrients Intakes
Time frame: 8 weeks
Dietary Micronutrients Intakes
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting and Standart Diet Therapy in people with Polycystic Ovary Syndrome and Weight Loss, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 13 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: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Weight lose (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 31 Jan 2025.