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: Recruiting
• 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 (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga Ramich, PD Dr.; Phone Number: +4933200882749; Email: olga.ramich@dife.de

Study Locations

• Germany
  • Nuthetal, Germany, 14558
    • Recruiting
    • German Institute of Human Nutrition Potsdam-Rehbruecke
    • Contact: Olga Ramich, PD Dr.; Email: olga.ramich@dife.de

Participation Criteria

Eligibility Criteria

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

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
Glucose tolerance, fasting glucose, and overall daily glycemic variation	Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring system	1-2 weeks
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
Sleep quality and duration	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	1-2 weeks
Physical activity	24-h physical activity will be monitored by an ActiGraph device	7 days
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

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): March 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): February 1, 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): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Obesity; Sleep; Glycemic control; Time-restricted feeding; Blood lipids; Meal timing
• Additional Relevant MeSH Terms: 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