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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Early Time-Restricted Feeding; Behavioral: Late Time-Restricted Feeding

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nuthetal, Germany, 14558
    • German Institute of Human Nutrition Potsdam-Rehbruecke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	Assessed using Matsuda index in oral glucose tolerance test (OGTT)	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic hormones and inflammatory markers	Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers	2 weeks
Blood lipids	Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides	2 weeks
Satiety and hunger scores	Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)	2 weeks
Expression of metabolic genes in adipose tissue	RNA-Seq analysis of subcutaneous adipose tissue samples	2 weeks
Social and economic decision behaviour	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)	2 weeks
Glucose tolerance, fasting glucose, and overall daily glycemic variation	Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring (CGM)	2 weeks (OGTT) and 14 days (CGM)
Oxidative stress markers	Malondialdehyde, 3-nitrotyrosine, and protein carbonyls	2 weeks
Blood pressure	Systolic and diastolic blood pressure	2 weeks
Liver enzymes	γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT), and alanine aminotransferase (AST)	2 weeks
Anthropometric parameters: body weight	Body weight in kilograms	2 weeks
Anthropometric parameters: BMI	BMI in kg/m^2	2 weeks
Anthropometric parameters: waist circumference	Waist circumference in centimeters	2 weeks
Anthropometric parameters: fat and lean mass	Fat and lean mass in kilograms assessed by bioelectrical impedance analysis	2 weeks
Food intake: eating times	Eating times in hours and minutes as assessed by food records	14 days
Food intake: calorie intake	Calorie intake in kilocalories as assessed by food records	14 days
Food intake: macronutrient composition	Macronutrient composition in percentage of energy intake as assessed by food records	14 days
Sleep quality and timing	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	2 weeks (PSQI) and 14 days (ActiGraph, sleep diary)
Physical activity	24-h physical activity as monitored by an ActiGraph device	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression in peripheral mononuclear blood cells (PBMC)	mRNA expression of clock, metabolic and inflammatory genes	2 weeks
Internal circadian phase	Circadian phase as assessed using the BodyTime assay in isolated CD14+ blood monocytes	2 weeks

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: Charite University, Berlin, Germany; University of Potsdam; Immanuel Krankenhaus Berlin, Germany; Hasso-Plattner Institut, Potsdam, Germany

Publications and helpful links

General Publications

• Peters B, Koppold-Liebscher DA, Schuppelius B, Steckhan N, Pfeiffer AFH, Kramer A, Michalsen A, Pivovarova-Ramich O. Effects of Early vs. Late Time-Restricted Eating on Cardiometabolic Health, Inflammation, and Sleep in Overweight and Obese Women: A Study Protocol for the ChronoFast Trial. Front Nutr. 2021 Nov 15;8:765543. doi: 10.3389/fnut.2021.765543. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Obesity; Sleep; Glycemic control; Time-restricted feeding; Blood lipids; Meal timing
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: DFG RA 3340/3-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No