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

Overweight and Obesity Clinical Trial

— ChronoFast  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04351672
• Other study ID #: DFG RA 3340/3-1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 2023

Study information

• Verified date: May 2021
• Source: German Institute of Human Nutrition
• Contact: Olga Ramich, PD Dr.
• Phone: +4933200882749
• Email: olga.ramich[@]dife.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Early Time-Restricted Feeding
Eat between 8 am and 4 pm for two weeks
• Late Time-Restricted Feeding
Eat between 1 pm and 9 pm for two weeks

Locations

Country	Name	City	State
Germany	German Institute of Human Nutrition Potsdam-Rehbruecke	Nuthetal

Sponsors (5)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Charite University, Berlin, Germany, Hasso-Plattner Institut, Potsdam, Germany, Immanuel Krankenhaus Berlin, Germany, University of Potsdam

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Assessed using Matsuda index in oral glucose tolerance test (OGTT)	2 weeks
Secondary	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
Secondary	Metabolic hormones and inflammatory markers	Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers	2 weeks
Secondary	Blood lipids	Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides	2 weeks
Secondary	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
Secondary	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
Secondary	Physical activity	24-h physical activity will be monitored by an ActiGraph device	7 days
Secondary	Expression of metabolic genes in adipose tissue	RNA-Seq analysis of subcutaneous adipose tissue samples	2 weeks
Secondary	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