Metabolic Impact of Time Restricted Feeding

Using Novel Digital Mobile Technology to Implement Time-restricted Feeding to Improve the Metabolic Health of Overweight and Obese Participants at Risk for Developing Diabetes

The investigators are interested in how time-restricted feeding will impact weight, sleep duration and efficacy, and activity levels in obese adults. Significant advances in digital mobile technology allow detailed measures of an individual's habits, permitting the opportunity for personalized dietary and lifestyle recommendations. This is especially relevant as time-restricted feeding appears to promote weight loss independent of calorie intake, potentially shifting the paradigm of dietary recommendations from a calorie-based to a time-based perspective.

Study Overview

• Status: Completed
• Conditions: Obesity; Diet Modification
• Intervention / Treatment: Behavioral: Dietary Counseling

Detailed Description

Given the obesity epidemic, there is intense medical and public interest in dietary and lifestyle management to mitigate obesity and its associated complications. Although weight loss has traditionally focused on restricting calories, it is well described that most people are unable to maintain the caloric restriction required to long term weight loss or maintenance. This proposal will address whether restricting the timing of food intake, rather than restricting calories, may facilitate weight loss and provide metabolic benefits. It has been recently shown that the average American eats over the course of 15 hours per day. Such an eating cycle dictates that most people are always in a fed metabolic state and likely misaligns circadian patterns. Time-restricted feeding (TRF) is the process of limiting food consumption to a specific window of time (e.g. 8 hours per day) and is associated with weight loss in humans and metabolic improvements in rodent studies. Significant advances in digital mobile technology now allow further detailed measures of an individual's habits to facilitate this analysis. Thus, the objective of this study is to test the health related effects of 12 week TRF (8 hour fed and 16 hour fasting cycle) in overweight/obese adults. The investigators hypothesize that TRF will 1) improve sleep duration, sleep efficacy, increase activity and increase basal metabolic rate, 2) promote weight loss and lower body fat, and 3) improve insulin sensitivity and postprandial hyperglycemia. The investigators expect these studies to show that TRF is effective and sustainable approach to improving metabolic parameters in overweight/obese individuals.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-65
2. BMI ≥ 25
3. Stable sleep and work schedule
4. Owns a smart phone
5. Capable of giving informed consent

Exclusion Criteria:

1. Pregnant
2. Nursing
3. Anticipation of pregnancy during the course of the study
4. Clinically significant medical issues as determined by the study clinician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Time Restricted; This group will receive dietary counseling.	Behavioral: Dietary Counseling; Counseling to only eat during a restricted amount of time.
No Intervention: Time Unrestricted; This group will not receive dietary counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Change in weight (kg) from baseline to study conclusion	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Change in body composition (% change in body fat as measured by DXA) from baseline to study conclusions	12 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Lisa Chow, MD, University of Minnesota, Division of Diabetes, Endocrinology and Metabolism

Publications and helpful links

General Publications

• Olawsky E, Zhang Y, Eberly LE, Helgeson ES, Chow LS. A New Analysis Tool for Continuous Glucose Monitor Data. J Diabetes Sci Technol. 2022 Nov;16(6):1496-1504. doi: 10.1177/19322968211028909. Epub 2021 Jul 20.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: obesity, diet, sleep activity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: MED-2016-25155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No