NCT04692532

Brief Summary

A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR, 25% energy restriction every day; or 3) control, ad libitum food intake daily, eating within more than 10 hours per day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable obesity

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

December 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

December 28, 2020

Last Update Submit

February 21, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    Measured by an electronic scale

    Measured at month 0, 6 and 12

Secondary Outcomes (29)

  • Change in fat mass, lean mass, visceral fat mass

    Measured at month 0, 6 and 12

  • Change in bone mineral density

    Measured at month 0, 6 and 12

  • Change in waist circumference

    Measured at month 0, 6 and 12

  • Change in Insulin resistance

    Measured at month 0, 6 and 12

  • Change in Insulin sensitivity

    Measured at month 0, 6 and 12

  • +24 more secondary outcomes

Study Arms (3)

8-hour Time restricted eating

EXPERIMENTAL

Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Other: 8-hour Time restricted eating

Calorie restriction

EXPERIMENTAL

25% energy restriction every day

Other: Calorie restriction

Control

NO INTERVENTION

Usual diet, Ad libitum intake, eating within \>10 hours per day

Interventions

8-hour Time restricted eatingOTHER

Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

8-hour Time restricted eating
Calorie restrictionOTHER

25% energy restriction every day

Calorie restriction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 65 years old
  • BMI between 30 and 50 kg/m2
  • Sedentary or lightly active (\<60 minutes/week of light activity for the 3 months prior to the study)

You may not qualify if:

  • Type 1 DM or Type 2 DM
  • History of eating disorders (anorexia, bulimia, or binge eating disorder)
  • Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg)
  • Are not able to keep a food diary or activity log for 7 consecutive days during screening
  • Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications)
  • Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
  • Are eating within less than a 10-hour window at baseline
  • Are pregnant, or trying to become pregnant
  • Are night shift workers
  • Are smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • Lin S, Cienfuegos S, Ezpeleta M, Pavlou V, Runchey MC, Varady KA. Effect of time restricted eating versus daily calorie restriction on sex hormones in males and females with obesity. medRxiv [Preprint]. 2024 May 15:2024.05.15.24307415. doi: 10.1101/2024.05.15.24307415.

    PMID: 38798539DERIVED

  • Lin S, Cienfuegos S, Ezpeleta M, Gabel K, Pavlou V, Mulas A, Chakos K, McStay M, Wu J, Tussing-Humphreys L, Alexandria SJ, Sanchez J, Unterman T, Varady KA. Time-Restricted Eating Without Calorie Counting for Weight Loss in a Racially Diverse Population : A Randomized Controlled Trial. Ann Intern Med. 2023 Jul;176(7):885-895. doi: 10.7326/M23-0052. Epub 2023 Jun 27.

    PMID: 37364268DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Krista Varady, PhD

    University of Illinois Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)