Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment

Sponsor

Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento (Other)

Overall Status

Completed

CT.gov ID

NCT06031753

Collaborator

Centro Medico ABC (Other)

Enrollment

Location

Arms

16.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Insulin Resistance	Behavioral: Time restricted eating	N/A

Detailed Description

After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle.

Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose.

Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction.

After data collection, statistical analyses was done to determine the effect of the different approaches.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eatinggroup 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.

Actual Study Start Date :

Jun 3, 2021

Actual Primary Completion Date :

Nov 27, 2021

Actual Study Completion Date :

Oct 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRE Only time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group.	Behavioral: Time restricted eating Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study. Other Names: time restricted eating with hormonal treatment
Experimental: TRE-HT They carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study.	Behavioral: Time restricted eating Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study. Other Names: time restricted eating with hormonal treatment
No Intervention: HT No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made.

Arm

Intervention/Treatment

Experimental: TRE

Only time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group.

Behavioral: Time restricted eating

Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.

Other Names:

time restricted eating with hormonal treatment

Experimental: TRE-HT

They carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study.

Behavioral: Time restricted eating

Other Names:

time restricted eating with hormonal treatment

No Intervention: HT

No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made.

Outcome Measures

Primary Outcome Measures

PCOS Rotterdam criteria [3 months]
Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.

Secondary Outcome Measures

Insulin resistance (IR) [3 months]
HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 20 - 35 years
Mild to moderate exercise at least 4 times per week
Body Mass Index (BMI) of 20-24.9
Diagnosis of PCOS by Rotterdam criteria
Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2.
PCOS Phenotype A, B, C
nulliparity
Signed informed consent letter

Exclusion Criteria:

Menopause or perimenopause
Night work shifts
Phenotype D (without hyperandrogenism)
Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases.
Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Médico ABC	Mexico city		Mexico	05300

Sponsors and Collaborators

Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
Centro Medico ABC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Isabela von Damm Longoria, Principal investigator, Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento

ClinicalTrials.gov Identifier:

NCT06031753

Other Study ID Numbers:

AYUSOP22

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Insulin Resistance

Syndrome

Study Results

No Results Posted as of Sep 11, 2023