Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men

NCT ID: NCT03969745

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-26
• Study Completion Date: 2019-05-30

Brief Summary

In the modern era, food access is widely available and it is not uncommon for the time between breakfast and a late night snack to exceed 14 hours. The investigators are interested in studying whether limiting this window to 8 hours will have any beneficial effects of human health as has been demonstrated in animal models. Eight men were asked to restrict their energy intake window to between 8 am and 4 pm for two weeks whilst maintaining their habitual diet (quantity and composition). Improvements in skeletal muscle and whole-body insulin sensitivity were observed but these were potentially confounded by an average weight loss of 1 kg. Therefore an additional control group was recruited to follow a daily caloric deficit of ~400 kilocalories without changing the timing of intake.

Detailed Description

All participants were monitored for a one week baseline period to establish their habitual physical activity and dietary patterns. This was done using food diaries, interstitial glucose monitors and a combined heart rate + accelerometer device. Participants consumed a standardised evening meal ~12h before visiting the laboratory to assess their metabolic response to a liquid test meal (1g/kg bodyweight dextrose and 0.4g/kg bodyweight protein) using the arterio-venous forearm balance model. Dual-energy X-ray absorptiometry scans, indirect calorimetry measurements and fasted and postprandial vastus lateralis biopsies were also obtained.

From the next day, participants either restricted their daily energy intake window to between 8 am and 4 pm or were prescribed a caloric deficit diet (~400 kilocalories/day) for two weeks. Physical activity, interstitial glucose concentrations and dietary patterns were monitored throughout. After this, participants visited the laboratory again to assess changes in metabolism and body composition.

Conditions

Metabolic Health

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Time restricted feeding (TRF)

Participants restricted their daily energy intake window to between 8 am and 4 pm for two weeks. They were encouraged to not alter the quantity and composition of their diet or alter physical activity patterns.

Group Type: EXPERIMENTAL

Time restricted feeding

Intervention Type: BEHAVIORAL

Restrict energy intake window to between 8am and 4pm

Caloric deficit

The investigators observed significant weight loss in the TRF group with participants reporting to consume \~400 kilocalories less per day. Therefore the investigators added a caloric deficit group to control for the effects of weight loss on metabolism. Total energy expenditure was measured for one week and was used to prescribe a 400 kilocalories/day energy deficit diet to follow for two weeks.

Group Type: ACTIVE_COMPARATOR

Caloric restriction

Intervention Type: BEHAVIORAL

Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing

Interventions

Time restricted feeding

Restrict energy intake window to between 8am and 4pm

Intervention Type: BEHAVIORAL

Caloric restriction

Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Healthy male between 18 and 35 years old
• Body mass index between 18 and 27.5 kg.m^-2
• Regular breakfast consumer, 5 or more days per week
• Moderate physical activity level (PAL between 1.6 and 2)

Exclusion Criteria

• Smoking
• Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (heart or blood) abnormalities including hypertension.
• Clinically significant abnormalities on screening including ECG abnormalities
• Routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
• High alcohol consumption (Routinely >4 units per day)
• Eating attitudes test (EAT-26) score > 20
• On an energy-restricted diet
• Significant body mass fluctuation in previous 3 months (>5%)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kostas Tsintzas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

MRC/ARUK Centre for Musculoskeletal Ageing, School of Life Sciences, University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

References

Jones R, Pabla P, Mallinson J, Nixon A, Taylor T, Bennett A, Tsintzas K. Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men. Am J Clin Nutr. 2020 Oct 1;112(4):1015-1028. doi: 10.1093/ajcn/nqaa192.

Reference Type: DERIVED

PMID: 32729615 (View on PubMed)

Other Identifiers

19-1705

Identifier Type: -

Identifier Source: org_study_id