Clinical trial NCT03129581: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diet Modification
Keywords: obesity, diet, sleep activity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, non-blinded, behavioral intervention pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota, Division of Diabetes, Endocrinology and Metabolism
name: Lisa Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.