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

NCT ID: NCT06031753

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2022-10-11

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.

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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Time restricted eating

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Time restricted eating

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

time restricted eating with hormonal treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro Medico ABC

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Isabela von Damm Longoria

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Médico ABC

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

AYUSOP22

Identifier Type: -

Identifier Source: org_study_id