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OpenTrials
Completed

NCT Number: NCT03129581

Metabolic Impact of Time Restricted Feeding

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Counseling

Behavioral

Counseling to only eat during a restricted amount of time.

Primary outcomes

  1. Weight

    Time frame: 12 weeks

    Change in weight (kg) from baseline to study conclusion

Secondary outcomes

  1. Body composition

    Time frame: 12 weeks

    Change in body composition (% change in body fat as measured by DXA) from baseline to study conclusions

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Apr 26, 2017
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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