Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604495296390 Date of Registration: 21/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Polycystic ovary syndrome: effect of two different diets on fat mass and on anthropometric, metabolic, and hormonal parameters.
Official scientific title Polycystic ovary syndrome: effect of two different diets on fat mass and on anthropometric, metabolic, and hormonal parameters.
Brief summary describing the background and objectives of the trial Background : Polycystic ovary syndrome (PCOS) is a syndrome of ovarian dysfunction defined, according to the Rotterdam Consensus, by the presence of at least two of the following three criteria: clinical and/or biological hyperandrogenism, dysovulation and ultrasound criteria for PCOS. PCOS is a common condition affecting approximately 15% of women of reproductive age. Its pathophysiology is based on ovarian hyperandrogenism and insulin resistance, which affects 70% of these patients. Patients with PCOS have a higher prevalence of overweight and obesity compared to women without PCOS. Obesity worsens the clinical and biochemical presentation of PCOS by increasing insulin resistance. This contributes, on the one hand, to the worsening of hyperandrogenism and ovulation dysfunction, and on the other hand, to an increased risk of diabetes and metabolic and cardiovascular diseases. Weight loss improves all symptoms of PCOS. Thus, lifestyle changes and weight management are recommended as first-line treatment for PCOS. However, weight management interventions are less effective in women with PCOS compared to those without PCOS. Hence the interest in this study, which will compare the effects of two types of diets on patients with PCOS. Objectives: 1. Primary objective : To evaluate the short-term effect of two different diets (the 16/8 intermittent fasting method and a low glycemic index diet) on fat mass in obese or overweight patients with PCOS. 2. Secondary objectives : To evaluate the effect of the two diets on weight, waist circumference, blood pressure, lean mass, and metabolic (fasting blood glucose, fasting insulin, total cholesterol, triglycerides, HDL cholesterol) and hormonal (total testosterone, sex hormone-binding globulin (SHBG), leptin, and anti-Müllerian hormone (AMH)) parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/01/2026
Actual trial start date 04/01/2026
Anticipated date of last follow up 30/06/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intermittent fasting 6 weeks This involves a 16/8 intermittent fasting diet. Within a 24-hour period, food is not consumed for 16 hours, and food intake is restricted for an 8-hour period (from 7:00 a.m. to 3:00 p.m. or from 8:00 a.m. to 4:00 p.m., depending on the patient's preference), with a 25% reduction in spontaneous daily caloric intake and while maintaining a two-meal-per-day rhythm. 20
Control Group Low glycemic index diet 6 weeks This diet recommends three meals per day, based on foods with a low glycemic index (less than 50), with a 25% reduction in spontaneous daily caloric intake. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged 18 to 40 years. Followed in the Endocrinology Department for polycystic ovary syndrome confirmed according to the 2003 Rotterdam criteria Body mass index: [25–40] kg/m² Desiring to lose weight Naive of both proposed diets Informed consent Pregnant or breastfeeding women. Personal history of illnesses that may influence weight or eating behavior: malabsorption, eating disorders (bulimia, binge eating, anorexia nervosa, night eating syndrome, or binge eating syndrome), uncontrolled endocrine disorders, psychiatric, neurological, or neoplastic disorders, severe renal or hepatic insufficiency. Current treatments that may alter weight or eating behavior, such as corticosteroid therapy and estrogen-progestin therapy. Diabetic patients. Patients already following a weight-loss diet and those who have stopped such a diet within the last three months. Patients who are legally incapacitated or whose mental capacity prevents them from following a diet. Non-compliance with the diet Discontinuation of follow-up during the study Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/12/2022 Ethics committee of the INNTA
Ethics Committee Address
Street address City Postal code Country
11 Rue jebel Lakhdhar bab Saadoun Tunis 1007 Tunisia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/12/2025 Ethics committee of the INNTA
Ethics Committee Address
Street address City Postal code Country
11 Rue jebel Lakhdhar bab Saadoun Tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the percentage of fat mass lost after the intervention before end 6 weeks after intervention
Secondary Outcome effect of the intervention on anthropometric parameters Before and 6 weeks after the intervention
Secondary Outcome effet of the intervention on metabolic parameters Before and 6 weeks after intervention
Secondary Outcome Effet of the intervention on hormonal parameters Before and 6 weeks after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut National Zouhair Kallel de nutrition et de Technologie Alimentaire 11 rue Jebel Lakhdhar, Bab Saadoun Tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Institut National Zouhair Kallel de Nutrition et de Technologie Alimentaire 11 rue Jebel Lakhdhar Bab Saadoun Tunis 1007 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tunisian Society of endocrinology diabetes and metabolism Endocrinology department, El Ain, Km 0.5 Sfax 3000 Tunisia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Shehrazed Kaaniche central university, 3 Street Hammadi Fareh Eljaziri Tunis Tunisia
Nourchene Borgi central university, 3 Street Hammadi Fareh Eljaziri tunis Tunisia
Mariem Ben Azzouz central university, 3 Street Hammadi Fareh Eljaziri tunis Tunisia
Imen Kallel central university, 3 Street Hammadi Fareh Eljaziri tunis Tunisia
Emna Talbi 11 Street Jebel Lakhdhar bab Saadoun Tunis Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ines Kammoun ines.kammoun@fmt.utm.tn 0021698352605 11 street jebel Lakhdhar bab Saadoun
City Postal code Country Position/Affiliation
Tunis Tunisia Endocrinology Department INNTA Faculty of medicine of Tunis University Tunis El Manar
Role Name Email Phone Street address
Public Enquiries Emna talbi emna.talbi@fmt.utm.tn 0021697666853 11 street jebel Lakhdhar bab Saadoun
City Postal code Country Position/Affiliation
Tunis Tunisia Biochemistry Laboratory INNTA Faculty of medicine of Tunis University Tunis El manar
Role Name Email Phone Street address
Scientific Enquiries Ines Kammoun ines.kammoun@fmt.utm.tn 0021698352605 11 street jebel Lakhdhar bab Saadoun
City Postal code Country Position/Affiliation
Tunis Tunisia Endocrinology Department INNTA Faculty of medicine of Tunis University Tunis El Manar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be available Informed Consent Form Informed consent form will be available after the article publication Consent form will be sent by email to anyone who requests it from the authors.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 24/03/2026 PACTR Admin 04 Jan 2026
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 24/03/2026 PACTR Admin Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/03/2026 The study could not be completed within the planned timeframe because the nutritionist involved in the project left for a research master's degree abroad. We obtained an extension of the ethical approval in December 2025. TRUE, Ethics committee of the INNTA, 11 Rue jebel Lakhdhar bab Saadoun, Tunis, 1007, Tunisia, , 23 Dec 2025, 0021698352605, ethique.innta@rns.tn, 41067_38347_4737.pdf