Intermittent Fasting Versus Daily Caloric Restriction for Weight Loss

Summary

The primary aim of this study is to is to determine if intermittent fasting (IMF) is an effective dietary strategy for treatment of obesity. A 1 year randomized trial will be used to compare weight loss generated by IMF versus Daily Caloric Restriction (DCR). The targeted weekly energy deficit is designed to be similar (\~30%) and a comprehensive behavioral support program will be provided to both groups. The primary outcome is weight change at the end of the 1 year intervention; follow up measures will also be obtained 6 months after completing the intervention. This study will provide robust data regarding weight loss effectiveness of IMF and will further our understanding of the impact of IMF on energy balance.

Conditions

• Obesity

Interventions

BEHAVIORAL

Daily Caloric Restriction (DCR)

Participants in this group will be given a calorie goal designed to produce a 34.3% energy deficit from estimated baseline weight maintenance energy requirements. Participants in this group will also receive a 12 month comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support DCR. Randomized groups will meet separately. Participants in this group will also be asked to increase moderate intensity physical activity to a target of 300 minutes per week.

BEHAVIORAL

Intermittent Fasting (IMF)

Participants in this group will be instructed to limit energy intake to 20% of estimated baseline energy requirements on three non-consecutive days per week, and to eat ad libitum the other 4 days per week. Participants in this group will also receive a 12 month comprehensive group based behavioral weight loss program and will be instructed in specific strategies to support IMF. Randomized groups will meet separately. Participants in this group will also be asked to increase moderate intensity physical activity to a target of 300 minutes per week.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Victoria Catenacci, MD · University of Colorado Anschutz Health and Wellness Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-22

Primary Completion

2022-08-05

Completion

2023-01-24

Countries

• United States

Study Locations