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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03969745
Other study ID # 19-1705
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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%)

Study Design


Related Conditions & MeSH terms


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.
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