Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes

NCT03854656 | Completed DMC

• 1 other identifier: NNF17OC0027822
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.

Conditions

Overweight and Obesity; PreDiabetes

Keywords

Overweight; Obesity; Time-restricted eating; Prediabetes

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  Measured in fasted state on a digital scale

  Change from baseline to the end of the intervention (after 12 weeks)

Secondary Outcomes (72)

• Body weight (kg)

  Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)

• Body mass index (kg/m^2)

  Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)

• Fat mass (kg)

  Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)

• Fat free mass (kg)

  Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)

• Fat percentage (%)

  Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)

Study Arms (2)

Control

NO INTERVENTION

Control group for 13 weeks (n=50). Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.

Time-restricted eating

EXPERIMENTAL

Time-restricted eating for 13 weeks (n=50). In addition to the intervention, participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.

Other: Time-restricted eating

Interventions

Time-restricted eating OTHER

Participants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles: 1. The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time 2. The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.

Time-restricted eating

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥30 kg/m2 or BMI ≥25 kg/m2 in combination with pre-diabetes (HbA1c ≥39-\<48 mmol/mol)
• Habitual eating/drinking window ≥12 hours (including foods/snacks and energy containing beverages e.g. soft drinks (except of water)) and an eating/drinking window of ≥14 hours minimum one day per week

You may not qualify if:

• Daily smoking
• For women: pregnancy, planned pregnancy (within the study period) or lactating
• Frequent travels over time zones (max one return trip/travel over times zones (˃one hour time difference) during the 13 weeks intervention).
• Shift work or partner engaged in shift work (if it affects the person's sleep and eating pattern)
• Unable to understand the informed consent and the study procedures
• Self-reported history of an eating disorder during the past three years
• Diabetes
• HbA1c ≥48 mmol/mol
• Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression
• Current treatment with medication or medical devices which significantly affect glucose metabolism, appetite, or energy balance
• Current treatment with antidepressants
• Bariatric surgery
• Implanted or portable electro-mechanical medical device such as a cardiac pacemaker, defibrillator or infusion pump
• Celiac disease, Crohn's disease, ulcerative colitis or proctitis
• Concomitant participation in other intervention studies

Sponsors & Collaborators

• Kristine Færch: lead
• University of Copenhagen: collaborator
• Aalborg University Hospital: collaborator
• IMotions A/S: collaborator
• University of Leeds: collaborator
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, DK-2810, Denmark

Location

Related Publications (3)

• Quist JS, Pedersen HE, Jensen MM, Clemmensen KKB, Bjerre N, Ekblond TS, Uldal S, Storling J, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Nyeland ME, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Blond MB, Faerch K. Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial. Lancet Healthy Longev. 2024 May;5(5):e314-e325. doi: 10.1016/S2666-7568(24)00028-X. Epub 2024 Apr 5.

  PMID: 38588687 DERIVED

• Jensen MM, Pedersen HE, Clemmensen KKB, Ekblond TS, Ried-Larsen M, Faerch K, Brock C, Quist JS. Associations Between Physical Activity and Gastrointestinal Transit Times in People with Normal Weight, Overweight, and Obesity. J Nutr. 2024 Jan;154(1):41-48. doi: 10.1016/j.tjnut.2023.06.005. Epub 2023 Jun 12.

  PMID: 37315794 DERIVED

• Quist JS, Jensen MM, Clemmensen KKB, Pedersen H, Bjerre N, Storling J, Blond MB, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Faerch K. Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. BMJ Open. 2020 Aug 26;10(8):e037166. doi: 10.1136/bmjopen-2020-037166.

  PMID: 32847912 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Kristine Færch, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher and Team Leader, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 26, 2019
• Study Start: February 25, 2019
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)