NCT04452968

Brief Summary

Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

June 26, 2020

Last Update Submit

November 23, 2020

Conditions

Polycystic Ovarian SyndromeWeight LossIntermittent Fasting

Outcome Measures

Primary Outcomes (1)

  • weight loss in kg

    in 3 months

Secondary Outcomes (3)

  • decrease in body fat percentage

    in 3 months

  • fasting plasma insulin

    in 3 months

  • blood pressure in mm Hg

    in 3 months

Study Arms (2)

intermittent fasting

EXPERIMENTAL

Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.

Behavioral: intermittent fastingBehavioral: Caloric restriction

caloric restriction

ACTIVE COMPARATOR

Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.

Behavioral: Caloric restriction

Interventions

intermittent fastingBEHAVIORAL

Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.

intermittent fasting
Caloric restrictionBEHAVIORAL

Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.

caloric restrictionintermittent fasting

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS as described by Rotterdam's criteria

You may not qualify if:

  • endocrine disorders
  • diabetic
  • hypertensive
  • Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
  • The body weight fluctuated more than 5% in recent 3 months.
  • Liver and kidney dysfunction: renal impairment, creatinine clearance rate \< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
  • History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  • History of thyroid diseases;
  • pregnant
  • Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight)
  • Patients who cannot be followed for 16 months (due to a health situation or migration)
  • Patients who are unwilling or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz Medical Center

Karachi, Sindh, 74600, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeWeight LossIntermittent Fasting

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Rubina Izhar

    Aziz Medical Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 1, 2020

Study Start

July 1, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)