Clinical trial NCT03969745: Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men
Official title: Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Health
Keywords: chrononutrition
metabolism
body composition
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants monitored for a one week baseline period before being allocated to either a caloric deficit group or a time-restricted feeding group for two weeks.
Primary purpose: PREVENTION

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.

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%)

Primary outcomes:
measure: Change in glucose uptake
timeFrame: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
measure: Change in branched chain amino acid uptake
timeFrame: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
measure: Change in whole-body insulin sensitivity
timeFrame: Pre and post intervention (15 days apart).
Secondary outcomes:
measure: Change in body composition
timeFrame: Pre and post intervention (15 days apart)
measure: Change in body composition
timeFrame: Pre and post intervention (15 days apart)
measure: Change in substrate metabolism
timeFrame: Pre and post intervention (15 days apart). In each condition there was one measurement in the fasted state and two measurements in the postprandial state.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: MRC/ARUK Centre for Musculoskeletal Ageing, School of Life Sciences, University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Kostas Tsintzas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.