Clinical trial NCT03867773: Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
Official title: Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.

Detailed description: Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.

Eligibility criteria: Inclusion Criteria:

* Male or female;
* body mass index (BMI) between 30.0 and 49.9 kg/m2;
* age between 18 and 65 years; sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week);
* weight stable for \>3 months prior to the beginning of the study (gain or loss \<4 kg);
* able to give written informed consent

Exclusion Criteria:

* Smoker; diabetic;
* taking weight loss medications;
* taking medication that requires eating food before (or with) the medication; history of eating disorders;
* night-shift workers;
* perimenopausal;
* pregnant women

Primary outcomes:
measure: Change from baseline to week 8 in body weight
timeFrame: Measured at week 1 and 8
Secondary outcomes:
measure: Change from baseline to week 8 in body composition
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in Insulin resistance
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in Fasting glucose
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in Fasting insulin
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in Blood pressure
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in adverse events
timeFrame: Measured weekly from baseline to week 8
measure: Change from baseline to week 8 in plasma lipids
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in heart rate
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in oxidative stress (8-isoprostane)
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in calorie and macronutrient intake
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in physical activity (steps/d)
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in diet adherence
timeFrame: Measured weekly from baseline to week 8
measure: Change from baseline to week 8 in sleep quality
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in insomnia severity
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in risk of sleep apnea
timeFrame: Measured at week 1 and 8
measure: Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)
timeFrame: Measured at week 1 and 8
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References:
citation: Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Lin S, Varady KA. Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Exp Gerontol. 2021 Oct 15;154:111545. doi: 10.1016/j.exger.2021.111545. Epub 2021 Aug 31.
citation: Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Wiseman E, Pavlou V, Lin S, Oliveira ML, Varady KA. Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cell Metab. 2020 Sep 1;32(3):366-378.e3. doi: 10.1016/j.cmet.2020.06.018. Epub 2020 Jul 15.