Dietary ManipulationNCT02605291
Dietary Macronutrient Manipulation and Substrate Oxidation During Exercise
A study testing Diet with a different macronutrient content A, Diet with a different macronutrient content B and Diet with a different macronutrient content C in people with Dietary Manipulation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Manipulation
- What is being tested?
- Diet with a different macronutrient content A, Diet with a different macronutrient content B and Diet with a different macronutrient content C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- Non-smoking - currently and for the past 5 years
- Fitness - V̇O2max 40-60 ml/kg/min
- Body mass index (20-25 kg/m2)
Who cannot join
- Known or suspected intolerance to the dietary interventions or their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
- Abnormal / extreme habitual dietary practice / intake
- Recent (≤3 months) dietary practice that may be deemed as low and/or high in macronutrients will be excluded.
- The taking of any prescribed medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, B15 2TT
About this study
Official title: The Effect of Dietary Macronutrient Manipulation and Glycogen Depleting Exercise on Substrate Oxidation at Rest and During Exercise
This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation during exercise.
Read the detailed description
One way to help reduce body fat is to expend more energy from the oxidation of fat as a fuel. Exercise is one way to increase fat oxidation. The extent to which exercise facilitates the use of fat as a fuel may be influenced by an individual's dietary intake.
This study aims to establish the effect of dietary macronutrient manipulation on muscle glycogen levels and substrate oxidation during exercise. Participants will undertake three separate trial periods. During each trial period participants will consume a diet containing different macronutrient compositions. For each of the trials the investigators will assess how the macronutrient composition of the diet affects muscle glycogen level and substrate oxidation during exercise.
- Conditions
- Dietary Manipulation
- Being tested
- Diet with a different macronutrient content A, Diet with a different macronutrient content B, Diet with a different macronutrient content C, Interval treadmill running exercise, Steady state treadmill running exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with a different macronutrient content AOther
A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.
Diet with a different macronutrient content BOther
A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.
Diet with a different macronutrient content COther
A diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3.
Interval treadmill running exerciseOther
Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Steady state treadmill running exerciseOther
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm 1 | Experimental | One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing. Receives: Other: Diet with a different macronutrient content A; Other: Interval treadmill running exercise; Other: Steady state treadmill running exercise |
| Experimental arm 2 | Experimental | One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing. Receives: Other: Diet with a different macronutrient content B; Other: Interval treadmill running exercise; Other: Steady state treadmill running exercise |
| Experimental arm 3 | Experimental | One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing. Receives: Other: Diet with a different macronutrient content C; Other: Interval treadmill running exercise; Other: Steady state treadmill running exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle glycogen concentration after dietary macronutrient manipulation
Muscle glycogen concentration will be measured after the dietary macronutrient manipulation intervention.
Measured: Day 7 of all experimental arms
Secondary outcomes (8)
Rate of fat oxidation at rest (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of fat oxidation at rest (g/min).
Measured: For 20 min on Day 7 of all experimental arms
Rate of fat oxidation during exercise (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) during exercise will be measured using indirect calorimetry to calculate the rate of fat oxidation during exercise (g/min).
Measured: During 60 min of exercise on day 7 of all experimental arms
Rate of carbohydrate oxidation at rest (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation at rest (g/min).
Measured: For 20 min on Day 7 of all experimental arms
Rate of carbohydrate oxidation during exercise (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) during exercise will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation during exercise (g/min).
Measured: During 60 min of exercise on day 7 of all experimental arms
Blood glucose concentration
Blood glucose concentration will be assessed in blood samples taken during exercise.
Measured: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
Blood insulin concentration
Blood insulin concentration will be assessed in blood samples taken during exercise.
Measured: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Blood fatty acid concentration
Blood fatty acid concentration will be assessed in blood samples taken during exercise.
Measured: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Change in intramuscular triglyceride (IMTG) content after exercise
IMTG utilisation during exercise (or change in IMTG content pre-post exercise) will be measured by comparing the IMTG content before and after exercise.
Measured: IMTG content measured just before and immediately after 60min of exercise on Day 7 of all experimental arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ManipulationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lucozade Ribena Suntory
- Responsible party
- Sponsor
- Investigators
- Gareth A Wallis, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605291
- Sponsor's protocol ID
- ERN_15-0963
- Status last verified
- Oct 2018
- First submitted
- 6 Nov 2015
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Macronutrient Manipulation and Glycogen Depleting Exercise on Substrate Oxidation at Rest and During Exercise
- ClinicalTrials.gov ID
- NCT02605291
- Acronym / sponsor ID
- ERN_15-0963
- Conditions
- Dietary Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Lucozade Ribena Suntory
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Nov 2015 (estimated)
- 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.
This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation during exercise.
Detailed description
One way to help reduce body fat is to expend more energy from the oxidation of fat as a fuel. Exercise is one way to increase fat oxidation. The extent to which exercise facilitates the use of fat as a fuel may be influenced by an individual's dietary intake.
This study aims to establish the effect of dietary macronutrient manipulation on muscle glycogen levels and substrate oxidation during exercise. Participants will undertake three separate trial periods. During each trial period participants will consume a diet containing different macronutrient compositions. For each of the trials the investigators will assess how the macronutrient composition of the diet affects muscle glycogen level and substrate oxidation during exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental arm 1 | Experimental | Other: Diet with a different macronutrient content A, Other: Interval treadmill running exercise, Other: Steady state treadmill running exerciseOne of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing. |
| Experimental arm 2 | Experimental | Other: Diet with a different macronutrient content B, Other: Interval treadmill running exercise, Other: Steady state treadmill running exerciseOne of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing. |
| Experimental arm 3 | Experimental | Other: Diet with a different macronutrient content C, Other: Interval treadmill running exercise, Other: Steady state treadmill running exerciseOne of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good general health
- Non-smoking - currently and for the past 5 years
- Fitness - V̇O2max 40-60 ml/kg/min
- Body mass index (20-25 kg/m2)
Key exclusion criteria (8 listed)
- Known or suspected intolerance to the dietary interventions or their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
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 |
|---|---|---|
| Diet with a different macronutrient content AA diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1. | Other | Experimental arm 1 |
| Diet with a different macronutrient content BA diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2. | Other | Experimental arm 2 |
| Diet with a different macronutrient content CA diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3. | Other | Experimental arm 3 |
| Interval treadmill running exerciseParticipants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms. | Other | Experimental arm 1, Experimental arm 2, Experimental arm 3 |
| Steady state treadmill running exerciseParticipants will perform steady state treadmill running exercise on day 7 of all experimental arms. | Other | Experimental arm 1, Experimental arm 2, Experimental arm 3 |
Primary outcome
Muscle glycogen concentration after dietary macronutrient manipulation
Time frame: Day 7 of all experimental arms
Muscle glycogen concentration will be measured after the dietary macronutrient manipulation intervention.
8 secondary outcomes
Rate of fat oxidation at rest (g/min)
Time frame: For 20 min on Day 7 of all experimental arms
Rate of fat oxidation during exercise (g/min)
Time frame: During 60 min of exercise on day 7 of all experimental arms
Rate of carbohydrate oxidation at rest (g/min)
Time frame: For 20 min on Day 7 of all experimental arms
Rate of carbohydrate oxidation during exercise (g/min)
Time frame: During 60 min of exercise on day 7 of all experimental arms
Blood glucose concentration
Time frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
Blood insulin concentration
Time frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Blood fatty acid concentration
Time frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Change in intramuscular triglyceride (IMTG) content after exercise
Time frame: IMTG content measured just before and immediately after 60min of exercise on Day 7 of all experimental arms
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 11 Oct 2018.
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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.
Gareth A Wallis, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet with a different macronutrient content A, Diet with a different macronutrient content B and Diet with a different macronutrient content C in people with Dietary Manipulation, run by University of Birmingham 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 11 Oct 2018. 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?
Muscle glycogen concentration after dietary macronutrient manipulation (time frame: Day 7 of all experimental arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018.