Effects of HICT and Intermittent Fasting on PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302166
• Other study ID #: REC/MS-PT/01720
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 033324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• PCO
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• High Intensity Circuit training (HICT)
High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided.
• Intermittent Fasting (IF)
Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol.
• Combination of HICT and IF
The participants will follow both HICT and IF for 8 weeks.

Locations

Country	Name	City	State
Pakistan	Bilal Hospital	Rawalpindi	Punjab
Pakistan	Noor Clinic	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCOS Morphology	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 .	8th Week
Secondary	Anthropometrics	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.	8th Week
Secondary	Clinical Hyperandrogenism	Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism.	8th Week
Secondary	Body Image concerns	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.	8th Week