Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism

NCT04414644 | Completed Results

• 2 other identifiers: 820064R21DK100787
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if, controlling for eating and sleep timing, caloric intake, and exercise, daytime vs. delayed eating affects body mass, adiposity, and energy metabolism in healthy adults.

Conditions

Obesity

Keywords

Metabolism; Eating; Circadian Rhythms

Outcome Measures

Primary Outcomes (1)

• Body Mass Changes Between the Daytime vs. Delayed Eating Conditions

  To determine if timing of food consumption (daytime vs. delayed eating) affects body mass (kg).

  pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)

Secondary Outcomes (2)

• Respiratory Quotient Changes in the Daytime vs Delayed Eating Conditions

  pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)

• Energy Expenditure Changes Between the Daytime and Delayed Eating Conditions

  pre-post changes between the daytime and delayed eating conditions; change for each condition is calculated from measures at baseline and 8 weeks (end of condition)

Study Arms (2)

Daytime Eating Condition

EXPERIMENTAL

Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.

Behavioral: Eating Condition

Delayed Eating Condition

EXPERIMENTAL

Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.

Behavioral: Eating Condition

Interventions

Eating Condition BEHAVIORAL

Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.

Daytime Eating Condition; Delayed Eating Condition

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults of all races and ethnicities
• Age 21-45; BMI 20-27 kg/m2
• stable weight (+/- 10 lbs) over the previous 6 months
• Women must be pre-menopausal with regular menstrual cycles.

You may not qualify if:

• Regular exercise more than 3 d/wk, for 30 min measured by exercise logs and actigraphy
• normal activity levels are required throughout the study (+/-30 min/wk of baseline level).
• Unstable, serious medical conditions
• use of medicine linked to weight gain/loss
• cancer, diabetes, or autoimmune disease
• use of illicit drugs, melatonin, diuretics or hypnotics
• current weight loss program; presence of a sleep disorder (determined by surveys and actigraphy)
• night shift work; extreme chronotypes (extreme larks or night owls)
• habitual waking outside of 0600 h-0930h
• habitual bedtime outside of 2200h to 2400h
• sleep duration outside of 6.5 to 8.5 h/night.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator
• Department of Health and Human Services: collaborator

Study Sites (1)

Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Allison KC, Hopkins CM, Ruggieri M, Spaeth AM, Ahima RS, Zhang Z, Taylor DM, Goel N. Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism. Curr Biol. 2021 Feb 8;31(3):650-657.e3. doi: 10.1016/j.cub.2020.10.092. Epub 2020 Nov 30.

  PMID: 33259790 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kelly Allison, PhD
• Organization: University of Pennsylvania

kca@pennmedicine.upenn.edu

215-898-2823

Study Officials

• Kelly C Allison, PhD

  Perelman School of Medicine at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Weight and Eating Disorders

Model Details: Randomized within subjects, cross-over design

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 4, 2020
• Study Start: October 8, 2014
• Primary Completion: June 4, 2017
• Study Completion: June 5, 2017
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)