ChronoFast: Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans

Sponsor

German Institute of Human Nutrition (Other)

Overall Status

Recruiting

CT.gov ID

NCT04351672

Collaborator

Charite University, Berlin, Germany (Other), Immanuel Krankenhaus Berlin, Germany (Other), Hasso-Plattner Institut, Potsdam, Germany (Other), University of Potsdam (Other)

Enrollment

Location

Arms

35.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This human dietary intervention study with a cross-over design aims to compare the effects of two isocaloric diets - early time-restricted feeding (TRF) vs. late TRF - on glycemic control and lipid metabolism in overweight and obese women.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Early Time-Restricted Feeding Behavioral: Late Time-Restricted Feeding	N/A

Detailed Description

The participants are randomly allocated to one of two study groups: In study group (A) participants will begin with the early TRF (e-TRF) intervention. They will consume their habitual food (and the habitual daily amount of food) between 8 am and 4 pm for two weeks. After a washout-phase participants will conduct the late TRF (l-TRF) and consume their habitual food between 1 pm and 9 pm for another two weeks. Study group (B) receives the same interventions in the reversed order. Both dietary regimens will result in 8-hr eating period and 16-hr fasting period during the 24h day.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Time-Restricted Feeding	Behavioral: Early Time-Restricted Feeding Eat between 8 am and 4 pm for two weeks Other Names: Early TRF eTRF
Experimental: Late Time-Restricted Feeding	Behavioral: Late Time-Restricted Feeding Eat between 1 pm and 9 pm for two weeks Other Names: Late TRF lTRF

Arm

Intervention/Treatment

Experimental: Early Time-Restricted Feeding

Behavioral: Early Time-Restricted Feeding

Eat between 8 am and 4 pm for two weeks

Other Names:

Early TRF

eTRF

Experimental: Late Time-Restricted Feeding

Behavioral: Late Time-Restricted Feeding

Eat between 1 pm and 9 pm for two weeks

Other Names:

Late TRF

lTRF

Outcome Measures

Primary Outcome Measures

Insulin sensitivity [2 weeks]
Assessed using Matsuda index in oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Glucose tolerance, fasting glucose, and overall daily glycemic variation [1-2 weeks]
Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring system
Metabolic hormones and inflammatory markers [2 weeks]
Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers
Blood lipids [2 weeks]
Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides
Satiety and hunger scores [2 weeks]
Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
Sleep quality and duration [1-2 weeks]
Assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device
Physical activity [7 days]
24-h physical activity will be monitored by an ActiGraph device
Expression of metabolic genes in adipose tissue [2 weeks]
RNA-Seq analysis of subcutaneous adipose tissue samples
Social and economic decision behaviour [2 weeks]
Assessed by computer tests together with the Barratt Impulsiveness Scale short version (BIS-15 with a score between 15 and 60, where higher values correspond to higher impulsiveness) and the UCLA Loneliness Scale (with a score between 20 and 100, where higher values correspond to higher subjectively perceived loneliness)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI 25-35 kg/m²

Exclusion Criteria:

prior diagnosis of type 1 or 2 diabetes
weight changes > 5% within past 3 months
current shift work or history of shift work
traveled across more than one time zone one month before the study
poor quality of sleep (PSQI score>10)
eating disorders, food intolerance/allergy, severe indigestion
Pregnant or breastfeeding
severe internal or psychiatric disorders or other conditions that might influence the outcome of the study