NCT06031753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 4, 2023

Last Update Submit

September 4, 2023

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • PCOS Rotterdam criteria

    Ovary volume \>9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.

    3 months

Secondary Outcomes (1)

  • Insulin resistance (IR)

    3 months

Study Arms (3)

TRE

EXPERIMENTAL

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

TRE-HT

EXPERIMENTAL

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

HT

NO INTERVENTION

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.

Interventions

Time restricted eatingBEHAVIORAL

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.

Also known as: time restricted eating with hormonal treatment
TRETRE-HT

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Médico ABC

Mexico City, 05300, Mexico

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 eating
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 11, 2023

Study Start

June 3, 2021

Primary Completion

November 27, 2021

Study Completion

October 11, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

ME(1)