Metabolic Impact of Time Restricted Feeding
Primary Purpose
Obesity, Diet Modification
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Counseling
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, diet, sleep activity
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- BMI ≥ 25
- Stable sleep and work schedule
- Owns a smart phone
- Capable of giving informed consent
Exclusion Criteria:
- Pregnant
- Nursing
- Anticipation of pregnancy during the course of the study
- Clinically significant medical issues as determined by the study clinician
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Time Restricted
Time Unrestricted
Arm Description
This group will receive dietary counseling.
This group will not receive dietary counseling.
Outcomes
Primary Outcome Measures
Weight
Change in weight (kg) from baseline to study conclusion
Secondary Outcome Measures
Body composition
Change in body composition (% change in body fat as measured by DXA) from baseline to study conclusions
Full Information
NCT ID
NCT03129581
First Posted
April 17, 2017
Last Updated
September 21, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03129581
Brief Title
Metabolic Impact of Time Restricted Feeding
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diet Modification
Keywords
obesity, diet, sleep activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, non-blinded, behavioral intervention pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Time Restricted
Arm Type
Active Comparator
Arm Description
This group will receive dietary counseling.
Arm Title
Time Unrestricted
Arm Type
No Intervention
Arm Description
This group will not receive dietary counseling.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Counseling
Intervention Description
Counseling to only eat during a restricted amount of time.
Primary Outcome Measure Information:
Title
Weight
Description
Change in weight (kg) from baseline to study conclusion
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Change in body composition (% change in body fat as measured by DXA) from baseline to study conclusions
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-65
BMI ≥ 25
Stable sleep and work schedule
Owns a smart phone
Capable of giving informed consent
Exclusion Criteria:
Pregnant
Nursing
Anticipation of pregnancy during the course of the study
Clinically significant medical issues as determined by the study clinician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Chow, MD
Organizational Affiliation
University of Minnesota, Division of Diabetes, Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34282646
Citation
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.
Results Reference
derived
Learn more about this trial
Metabolic Impact of Time Restricted Feeding
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