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Overweight and ObesityChronoFastNCT04351672

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

A study testing Early Time-Restricted Feeding and Late Time-Restricted Feeding in people with Overweight and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Overweight and Obesity
What is being tested?
Early Time-Restricted Feeding and Late Time-Restricted Feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteGermany
Study dates
23 Jun 2020to 28 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI 25-35 kg/m²

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • German Institute of Human Nutrition Potsdam-Rehbruecke

    Nuthetal, 14558

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Early Time-Restricted Feeding, Late Time-Restricted Feeding
Keywords
Time-restricted feeding, Meal timing, Obesity, Glycemic control, Blood lipids, Inflammation, Sleep
Medical subject headings
Overweight, Obesity, Intermittent Fasting, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Time-Restricted FeedingBehavioural

    Also called Early TRF, eTRF

    Eat between 8 am and 4 pm for two weeks

  • Late Time-Restricted FeedingBehavioural

    Also called Late TRF, lTRF

    Eat between 1 pm and 9 pm for two weeks

Study groups in NCT04351672
Study groupRoleWhat they receive
Early Time-Restricted FeedingExperimentalNot described
Receives: Behavioral: Early Time-Restricted Feeding
Late Time-Restricted FeedingExperimentalNot described
Receives: Behavioral: Late Time-Restricted Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin sensitivity

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

    Measured: 2 weeks

Secondary outcomes (18)

  1. 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)

    Measured: 2 weeks (OGTT) and 14 days (CGM)

  2. Metabolic hormones and inflammatory markers

    Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers

    Measured: 2 weeks

  3. Oxidative stress markers

    Malondialdehyde, 3-nitrotyrosine, and protein carbonyls

    Measured: 2 weeks

  4. Blood lipids

    Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides

    Measured: 2 weeks

  5. Blood pressure

    Systolic and diastolic blood pressure

    Measured: 2 weeks

  6. Liver enzymes

    γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT), and alanine aminotransferase (AST)

    Measured: 2 weeks

  7. Anthropometric parameters: body weight

    Body weight in kilograms

    Measured: 2 weeks

  8. Anthropometric parameters: BMI

    BMI in kg/m^2

    Measured: 2 weeks

  9. Anthropometric parameters: waist circumference

    Waist circumference in centimeters

    Measured: 2 weeks

  10. Anthropometric parameters: fat and lean mass

    Fat and lean mass in kilograms assessed by bioelectrical impedance analysis

    Measured: 2 weeks

  11. Food intake: eating times

    Eating times in hours and minutes as assessed by food records

    Measured: 14 days

  12. Food intake: calorie intake

    Calorie intake in kilocalories as assessed by food records

    Measured: 14 days

  13. Food intake: macronutrient composition

    Macronutrient composition in percentage of energy intake as assessed by food records

    Measured: 14 days

  14. Satiety and hunger scores

    Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)

    Measured: 2 weeks

  15. 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

    Measured: 2 weeks (PSQI) and 14 days (ActiGraph, sleep diary)

  16. Physical activity

    24-h physical activity as monitored by an ActiGraph device

    Measured: 14 days

  17. Expression of metabolic genes in adipose tissue

    RNA-Seq analysis of subcutaneous adipose tissue samples

    Measured: 2 weeks

  18. 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)

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start23 Jun 2020
  3. Primary completion20 Dec 2021
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04351672
Sponsor's protocol ID
DFG RA 3340/3-1
Acronym
ChronoFast
Status last verified
Aug 2024
First submitted
7 Apr 2020
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Peters B, Jokisch J, Schwarz J, Schuppelius B, Pfeiffer AFH, Michalsen A, Kramer A, Pivovarova-Ramich O. Early but not late time-restricted eating improves an actigraphy-estimated sleep quality in women with overweight or obesity: secondary analysis of the crossover ChronoFast trial. Front Nutr. 2026 May 26;13:1823259. doi: 10.3389/fnut.2026.1823259. eCollection 2026.

    PubMed 42272904

  • 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.

    PubMed 34869534

Questions about this trial

What is this clinical trial studying?

A study testing Early Time-Restricted Feeding and Late Time-Restricted Feeding in people with Overweight and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin sensitivity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04351672, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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