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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Immanuel Krankenhaus Berlin, Germany | UNKNOWN |
| Hasso-Plattner Institut, Potsdam, Germany | UNKNOWN |
| University of Potsdam |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Time-Restricted Feeding | Experimental |
| |
| Late Time-Restricted Feeding | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Time-Restricted Feeding | Behavioral | Eat between 8 am and 4 pm for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Assessed using Matsuda index in oral glucose tolerance test (OGTT) | 2 weeks |
| 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 (CGM) | 2 weeks (OGTT) and 14 days (CGM) |
| Metabolic hormones and inflammatory markers |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression in peripheral mononuclear blood cells (PBMC) | mRNA expression of clock, metabolic and inflammatory genes | 2 weeks |
| Internal circadian phase | Circadian phase as assessed using the BodyTime assay in isolated CD14+ blood monocytes |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institute of Human Nutrition Potsdam-Rehbruecke | Nuthetal | 14558 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42272904 | Derived | 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. | |
| 34869534 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| OTHER |
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| Late Time-Restricted Feeding | Behavioral | Eat between 1 pm and 9 pm for two weeks |
|
|
Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers
| 2 weeks |
| Oxidative stress markers | Malondialdehyde, 3-nitrotyrosine, and protein carbonyls | 2 weeks |
| Blood lipids | Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides | 2 weeks |
| Blood pressure | Systolic and diastolic blood pressure | 2 weeks |
| Liver enzymes | γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT), and alanine aminotransferase (AST) | 2 weeks |
| Anthropometric parameters: body weight | Body weight in kilograms | 2 weeks |
| Anthropometric parameters: BMI | BMI in kg/m^2 | 2 weeks |
| Anthropometric parameters: waist circumference | Waist circumference in centimeters | 2 weeks |
| Anthropometric parameters: fat and lean mass | Fat and lean mass in kilograms assessed by bioelectrical impedance analysis | 2 weeks |
| Food intake: eating times | Eating times in hours and minutes as assessed by food records | 14 days |
| Food intake: calorie intake | Calorie intake in kilocalories as assessed by food records | 14 days |
| Food intake: macronutrient composition | Macronutrient composition in percentage of energy intake as assessed by food records | 14 days |
| 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 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 | 2 weeks (PSQI) and 14 days (ActiGraph, sleep diary) |
| Physical activity | 24-h physical activity as monitored by an ActiGraph device | 14 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 |
| 2 weeks |
| 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |