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

G

German Institute of Human Nutrition

Status

Completed

Conditions

Overweight and Obesity

Treatments

Behavioral: Late Time-Restricted Feeding
Behavioral: Early Time-Restricted Feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT04351672
DFG RA 3340/3-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Early Time-Restricted Feeding
Experimental group
Treatment:
Behavioral: Early Time-Restricted Feeding
Late Time-Restricted Feeding
Experimental group
Treatment:
Behavioral: Late Time-Restricted Feeding

Trial contacts and locations

1

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Central trial contact

Olga Ramich, PD Dr.

Data sourced from clinicaltrials.gov

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