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

Metabolic Health Clinical Trial

— TRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969745
• Other study ID #: 19-1705
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2019
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Metabolic Health

Intervention

Behavioral:
• Time restricted feeding
Restrict energy intake window to between 8am and 4pm
• Caloric restriction
Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing

Locations

Country	Name	City	State
United Kingdom	MRC/ARUK Centre for Musculoskeletal Ageing, School of Life Sciences, University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose uptake	The arterio-venous forearm balance method was used to assess skeletal muscle glucose uptake in micromoles/min.	Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
Primary	Change in branched chain amino acid uptake	The arterio-venous forearm balance method was used to assess skeletal muscle branched chain amino acid uptake in micromoles/min.	Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
Primary	Change in whole-body insulin sensitivity	The Matsuda Index was used to calculate an index of whole-body insulin sensitivity using values of fasted and postprandial glucose and insulin. Measured in arbitrary units and higher values indicates increased insulin sensitivity. All individual changes will be reported.	Pre and post intervention (15 days apart).
Secondary	Change in body composition	Dual-energy X-ray absorptiometry scans to assess changes in fat mass in kg	Pre and post intervention (15 days apart)
Secondary	Change in body composition	Dual-energy X-ray absorptiometry scans to assess changes in fat-free mass in kg	Pre and post intervention (15 days apart)
Secondary	Change in substrate metabolism	Rates of oxygen consumption and carbon dioxide production were measured using indirect calorimetry. These were used to calculate rates of fat and carbohydrate metabolism in grams/min.	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.