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Completed

NCT Number: NCT04351672

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

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Fasting Feeding Behavior Inflammation Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

German Institute of Human Nutrition Potsdam-Rehbruecke

Nuthetal, 14558, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Time-Restricted Feeding

Behavioral

Eat between 8 am and 4 pm for two weeks

Other names: Early TRF, eTRF

Late Time-Restricted Feeding

Behavioral

Eat between 1 pm and 9 pm for two weeks

Other names: Late TRF, lTRF

Primary outcomes

  1. Insulin sensitivity

    Time frame: 2 weeks

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

Secondary outcomes

  1. Glucose tolerance, fasting glucose, and overall daily glycemic variation

    Time frame: 2 weeks (OGTT) and 14 days (CGM)

    Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring (CGM)

  2. Metabolic hormones and inflammatory markers

    Time frame: 2 weeks

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

  3. Oxidative stress markers

    Time frame: 2 weeks

    Malondialdehyde, 3-nitrotyrosine, and protein carbonyls

  4. Blood lipids

    Time frame: 2 weeks

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

  5. Blood pressure

    Time frame: 2 weeks

    Systolic and diastolic blood pressure

  6. Liver enzymes

    Time frame: 2 weeks

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

  7. Anthropometric parameters: body weight

    Time frame: 2 weeks

    Body weight in kilograms

  8. Anthropometric parameters: BMI

    Time frame: 2 weeks

    BMI in kg/m^2

  9. Anthropometric parameters: waist circumference

    Time frame: 2 weeks

    Waist circumference in centimeters

  10. Anthropometric parameters: fat and lean mass

    Time frame: 2 weeks

    Fat and lean mass in kilograms assessed by bioelectrical impedance analysis

  11. Food intake: eating times

    Time frame: 14 days

    Eating times in hours and minutes as assessed by food records

  12. Food intake: calorie intake

    Time frame: 14 days

    Calorie intake in kilocalories as assessed by food records

  13. Food intake: macronutrient composition

    Time frame: 14 days

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

  14. Satiety and hunger scores

    Time frame: 2 weeks

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

  15. Sleep quality and timing

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

    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

  16. Physical activity

    Time frame: 14 days

    24-h physical activity as monitored by an ActiGraph device

  17. Expression of metabolic genes in adipose tissue

    Time frame: 2 weeks

    RNA-Seq analysis of subcutaneous adipose tissue samples

  18. Social and economic decision behaviour

    Time frame: 2 weeks

    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)

Other outcomes

  1. Gene expression in peripheral mononuclear blood cells (PBMC)

    Time frame: 2 weeks

    mRNA expression of clock, metabolic and inflammatory genes

  2. Internal circadian phase

    Time frame: 2 weeks

    Circadian phase as assessed using the BodyTime assay in isolated CD14+ blood monocytes

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Charite University, Berlin, Germany
  • Hasso-Plattner Institut, Potsdam, Germany
  • Immanuel Krankenhaus Berlin, Germany
  • University of Potsdam

Registry information

Acronym: ChronoFast

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Apr 17, 2020
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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