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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06031753
Other study ID # AYUSOP22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2021
Est. completion date October 11, 2022

Study information

Verified date September 2023
Source Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 11, 2022
Est. primary completion date November 27, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Mexico Centro Médico ABC Mexico city

Sponsors (2)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary PCOS Rotterdam criteria Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation. 3 months
Secondary Insulin resistance (IR) HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance 3 months
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