Metabolic HealthTRFNCT03969745
Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men
A study testing Time restricted feeding and Caloric restriction in people with Metabolic Health, run by University of Nottingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health
- What is being tested?
- Time restricted feeding and Caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jun 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC/ARUK Centre for Musculoskeletal Ageing, School of Life Sciences, University of Nottingham
Nottingham, NG7 2UH
About this study
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.
Read the 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
- Being tested
- Time restricted feeding, Caloric restriction
- Keywords
- chrononutrition, metabolism, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
Restrict energy intake window to between 8am and 4pm
Caloric restrictionBehavioural
Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing
| Study group | Role | What they receive |
|---|---|---|
| Time restricted feeding (TRF) | Experimental | 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. Receives: Behavioral: Time restricted feeding |
| Caloric deficit | Active comparator | 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. Receives: Behavioral: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose uptake
The arterio-venous forearm balance method was used to assess skeletal muscle glucose uptake in micromoles/min.
Measured: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
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.
Measured: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
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.
Measured: Pre and post intervention (15 days apart).
Secondary outcomes (3)
Change in body composition
Dual-energy X-ray absorptiometry scans to assess changes in fat mass in kg
Measured: Pre and post intervention (15 days apart)
Change in body composition
Dual-energy X-ray absorptiometry scans to assess changes in fat-free mass in kg
Measured: Pre and post intervention (15 days apart)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start26 Jun 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kostas Tsintzas, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969745
- Sponsor's protocol ID
- 19-1705
- Acronym
- TRF
- Status last verified
- Sep 2019
- First submitted
- 30 Apr 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32729615
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men
- ClinicalTrials.gov ID
- NCT03969745
- Acronym / sponsor ID
- TRF / 19-1705
- Conditions
- Metabolic Health
- Keywords
- chrononutrition, metabolism, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Time restricted feeding (TRF) | Experimental | Behavioral: Time restricted feedingParticipants 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. |
| Caloric deficit | Active comparator | Behavioral: Caloric restrictionThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted feedingRestrict energy intake window to between 8am and 4pm | Behavioural | Time restricted feeding (TRF) |
| Caloric restrictionFollow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing | Behavioural | Caloric deficit |
Primary outcome
Change in glucose uptake
Time frame: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
The arterio-venous forearm balance method was used to assess skeletal muscle glucose uptake in micromoles/min.
Change in branched chain amino acid uptake
Time frame: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink
The arterio-venous forearm balance method was used to assess skeletal muscle branched chain amino acid uptake in micromoles/min.
Change in whole-body insulin sensitivity
Time frame: Pre and post intervention (15 days apart).
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.
3 secondary outcomes
Change in body composition
Time frame: Pre and post intervention (15 days apart)
Change in body composition
Time frame: Pre and post intervention (15 days apart)
Change in substrate metabolism
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 32729615Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kostas Tsintzas, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding and Caloric restriction in people with Metabolic Health, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose uptake (time frame: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.