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

Primary Purpose

Overweight and Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Early Time-Restricted Feeding
Late Time-Restricted Feeding
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Time-restricted feeding, Meal timing, Obesity, Glycemic control, Blood lipids, Inflammation, Sleep

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • German Institute of Human Nutrition Potsdam-RehbrueckeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Time-Restricted Feeding

Late Time-Restricted Feeding

Arm Description

Outcomes

Primary Outcome Measures

Insulin sensitivity
Assessed using Matsuda index in oral glucose tolerance test (OGTT)

Secondary Outcome Measures

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
Metabolic hormones and inflammatory markers
Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers
Blood lipids
Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides
Satiety and hunger scores
Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
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
Physical activity
24-h physical activity will be monitored by an ActiGraph device
Expression of metabolic genes in adipose tissue
RNA-Seq analysis of subcutaneous adipose tissue samples
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)

Full Information

First Posted
April 7, 2020
Last Updated
May 18, 2021
Sponsor
German Institute of Human Nutrition
Collaborators
Charite University, Berlin, Germany, Immanuel Krankenhaus Berlin, Germany, Hasso-Plattner Institut, Potsdam, Germany, University of Potsdam
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1. Study Identification

Unique Protocol Identification Number
NCT04351672
Brief Title
Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans
Acronym
ChronoFast
Official Title
Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
Charite University, Berlin, Germany, Immanuel Krankenhaus Berlin, Germany, Hasso-Plattner Institut, Potsdam, Germany, University of Potsdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Time-restricted feeding, Meal timing, Obesity, Glycemic control, Blood lipids, Inflammation, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Time-Restricted Feeding
Arm Type
Experimental
Arm Title
Late Time-Restricted Feeding
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Early Time-Restricted Feeding
Other Intervention Name(s)
Early TRF, eTRF
Intervention Description
Eat between 8 am and 4 pm for two weeks
Intervention Type
Behavioral
Intervention Name(s)
Late Time-Restricted Feeding
Other Intervention Name(s)
Late TRF, lTRF
Intervention Description
Eat between 1 pm and 9 pm for two weeks
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Assessed using Matsuda index in oral glucose tolerance test (OGTT)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Glucose tolerance, fasting glucose, and overall daily glycemic variation
Description
Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring system
Time Frame
1-2 weeks
Title
Metabolic hormones and inflammatory markers
Description
Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers
Time Frame
2 weeks
Title
Blood lipids
Description
Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides
Time Frame
2 weeks
Title
Satiety and hunger scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
Time Frame
2 weeks
Title
Sleep quality and duration
Description
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
Time Frame
1-2 weeks
Title
Physical activity
Description
24-h physical activity will be monitored by an ActiGraph device
Time Frame
7 days
Title
Expression of metabolic genes in adipose tissue
Description
RNA-Seq analysis of subcutaneous adipose tissue samples
Time Frame
2 weeks
Title
Social and economic decision behaviour
Description
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)
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Ramich, PD Dr.
Phone
+4933200882749
Email
olga.ramich@dife.de
Facility Information:
Facility Name
German Institute of Human Nutrition Potsdam-Rehbruecke
City
Nuthetal
ZIP/Postal Code
14558
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Ramich, PD Dr.
Email
olga.ramich@dife.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
34869534
Citation
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.
Results Reference
derived

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

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