Effects of HICT and Intermittent Fasting on PCOS

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome; PCO

• Registration Number: NCT06302166
• Lead Sponsor: Riphah International University

Brief Summary

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-08
• Study Start: 2024-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-19
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Unmarried females

• Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:

  • PCOM on US
  • Ovulatory dysfunction
  • Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)

• Not engaged in any regular lifestyle intervention for <3 Months prior to inclusion

Exclusion Criteria

• Use of Estrogen, Progestin or combination.
• Taking medications or supplements for Insulin resistance < 3 months prior to the inclusion
• Type I or II DM
• Hypo/hyperthyroidism
• BMI ≥27 (Obese according to BMI Asia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PCOS Morphology	8th Week	Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 .

Secondary Outcome Measures

Name	Time	Method
Body Image concerns	8th Week	Changes from baseline Body Image concerns will be measured using The BSQ which is a self-reported measurement of the body shape concerns designed for women to measure concerns about body image problems.
Anthropometrics	8th Week	Changes from baseline Weight (kg) will be measured by weight scale while height (ft) will be measured by stadiometer. BMI will be calculated by dividing your weight in kilograms (kg) by your height in meters squared (m 2 ). Waist Circumference (WC) will be measured in centimeters, between the costal margin and the pelvic brim, and Hip Circumference (HC) will be measured in cm at the level of the symphysis pubis by inches tape.
Clinical Hyperandrogenism	8th Week	Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism.

Trial Locations

Locations (2)

Bilal Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan

Noor Clinic; 🇵🇰 Rawalpindi, Punjab, Pakistan