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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Late Time-Restricted Feeding; Behavioral: Early Time-Restricted Feeding

• Registration Number: NCT04351672
• Lead Sponsor: German Institute of Human Nutrition

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.

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 Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Study Start: 2020-06-23
• Primary Completion: 2021-12-20
• Study Completion: 2023-02-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Late Time-Restricted Feeding	Late Time-Restricted Feeding	-
Early Time-Restricted Feeding	Early Time-Restricted Feeding	-

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	2 weeks	Assessed using Matsuda index in oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Name	Time	Method
Anthropometric parameters: BMI	2 weeks	BMI in kg/m\^2
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
Anthropometric parameters: fat and lean mass	2 weeks	Fat and lean mass in kilograms assessed by bioelectrical impedance analysis
Food intake: macronutrient composition	14 days	Macronutrient composition in percentage of energy intake as assessed by food records
Sleep quality and timing	2 weeks (PSQI) and 14 days (ActiGraph, sleep diary)	Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and by the ActiGraph device; sleep timing (sleep onset and offset) as monitored using a sleep diary
Glucose tolerance, fasting glucose, and overall daily glycemic variation	2 weeks (OGTT) and 14 days (CGM)	Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring (CGM)
Oxidative stress markers	2 weeks	Malondialdehyde, 3-nitrotyrosine, and protein carbonyls
Food intake: eating times	14 days	Eating times in hours and minutes as assessed by food records
Food intake: calorie intake	14 days	Calorie intake in kilocalories as assessed by food records
Physical activity	14 days	24-h physical activity as monitored by an ActiGraph device
Anthropometric parameters: waist circumference	2 weeks	Waist circumference in centimeters
Blood pressure	2 weeks	Systolic and diastolic blood pressure
Liver enzymes	2 weeks	γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT), and alanine aminotransferase (AST)
Anthropometric parameters: body weight	2 weeks	Body weight in kilograms
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)
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)

Trial Locations

Locations (1)

German Institute of Human Nutrition Potsdam-Rehbruecke; 🇩🇪 Nuthetal, Germany