- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07711782
Management of Polycystic Ovarian Syndrome-associated Reproductive Dysfunction Through Kefir Supplementation
Managing Polycystic Ovarian Syndrome- Associated Reproductive Dysfunction Through Kefir Supplementation
Study Overview
Status
Intervention / Treatment
Detailed Description
The target population were females between the ages of 18 and 25 years who have the history of amenorrhea or delayed periods, unusual weight gain, cyst in their ovaries, hormonal imbalance or thyroid issue. Once consent is given, participants were then be randomly assigned to receive the prescribed intervention or act as a control.
(C0) Control group: Participants were only be subjected to use a regular calorie deficit diet plan (G1) Experimental group: Participants were advised to take water 250ml of water kefir per day in their mid-morning snack time for 2 months.
At baseline, nutritional assessment based on weight and height, BMI, waist circumference, blood pressure, fasting blood glucose, lipid panels (HDL, LDL, total cholesterol, triglycerides), FHS Levels, LH levels, TSH levels was done after 8 weeks of intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lahore, Pakistan
- The University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females of age 18-25 will be selected.
- Females suffering from amenorrhea or cycle longer then 35days were selected.
- Females with PCOS were selected.
- Females with BMI 18.5-29.9 were selected in this research.
- Females with thyroid issues were selected.
Exclusion Criteria:
- Pregnant and breast-feeding females were not included.
- Those who smoke were not included.
- Those who consume alcohol were not included.
- Those suffering from endocrine diseases were not be included.
- Those taking lipid- lowering drugs or blood pressure regulating medications were not be included.
- Those taking antibiotics or medications related to PCOS treatment or vitamin-mineral or probiotics within 1 month prior to study inclusion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Calorie deficit diet plan
|
Participants were subjected to use a regular calorie deficit diet plan
|
|
Experimental: Experimental Group
Diet plan + 250ml kefir water
|
Participants were advised to take water 250ml of water kefir per day in their mid-morning snack time for 2 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid Profile
Time Frame: 8 weeks
|
Blood lipid profile were obtained using fasting blood samples to determine serum total cholesterol, high-density lipoprotein cholesterol (HD L-C), low density lipoprotein cholesterol (LDL-C) and triglycerides.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FSH (follicle stimulating hormone)
Time Frame: 8 weeks
|
Blood test will be done to check the reproductive health
|
8 weeks
|
|
LH (luteinizing hormone)
Time Frame: 8 weeks
|
Blood test to check the secretion of luteinizing hormone and how it triggers ovulation and stimulate testosterone production.
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TSH (Thyroid stimulating hormone test)
Time Frame: 8 weeks
|
Blood test were done to monitor the levels of TSH.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Cysts
- Cysts
- Polycystic Ovary Syndrome
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- IRB-UOL-FAHS/761/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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