Clinical trial NCT04351672: Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans
Official title: Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Time-restricted feeding
Meal timing
Obesity
Glycemic control
Blood lipids
Inflammation
Sleep
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Immanuel Krankenhaus Berlin, Germany
name: Hasso-Plattner Institut, Potsdam, Germany
name: University of Potsdam
First posted: 2020-04-17
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 2 weeks
Secondary outcomes:
measure: Glucose tolerance, fasting glucose, and overall daily glycemic variation
timeFrame: 2 weeks (OGTT) and 14 days (CGM)
measure: Metabolic hormones and inflammatory markers
timeFrame: 2 weeks
measure: Oxidative stress markers
timeFrame: 2 weeks
measure: Blood lipids
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: Liver enzymes
timeFrame: 2 weeks
measure: Anthropometric parameters: body weight
timeFrame: 2 weeks
measure: Anthropometric parameters: BMI
timeFrame: 2 weeks
measure: Anthropometric parameters: waist circumference
timeFrame: 2 weeks
measure: Anthropometric parameters: fat and lean mass
timeFrame: 2 weeks
measure: Food intake: eating times
timeFrame: 14 days
measure: Food intake: calorie intake
timeFrame: 14 days
measure: Food intake: macronutrient composition
timeFrame: 14 days
measure: Satiety and hunger scores
timeFrame: 2 weeks
measure: Sleep quality and timing
timeFrame: 2 weeks (PSQI) and 14 days (ActiGraph, sleep diary)
measure: Physical activity
timeFrame: 14 days
measure: Expression of metabolic genes in adipose tissue
timeFrame: 2 weeks
measure: Social and economic decision behaviour
timeFrame: 2 weeks
Other outcomes:
measure: Gene expression in peripheral mononuclear blood cells (PBMC)
timeFrame: 2 weeks
measure: Internal circadian phase
timeFrame: 2 weeks
Locations:
city: Nuthetal
country: Germany
facility: German Institute of Human Nutrition Potsdam-Rehbruecke
Study officials:
References:
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.