Physical ActivityNCT03917810
Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
A study testing Diet in people with Physical Activity, run by University of Bath at 1 site in United Kingdom.
Trial summary
Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 1 Sep 2021
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Male
- Able and willing to provide informed consent and safely comply with study procedures
- No anticipated changes in physical activity during the study (e.g. holidays)
Who cannot join
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)•Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (±3%)
Trial locations and contacts
1 site in 1 country.
About this study
Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured.
Each participant will undergo 3 days of each diet:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Read the detailed description
Guidelines calling for dietary free sugars to be reduced have been formulated from evidence that diets high in sugar are associated with high energy intake. In theory, by reducing the intake of sugars, calorie surplus will be reduced and energy balance will be maintained. However, when referring to interventions/behaviours that influence energy balance, both sides of the energy balance equation need to be considered. Alterations in nutrients may influence aspects of energy expenditure, not solely energy intake, and this may have implications for the efficacy of guidelines seeking to influence energy intake.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Furthermore, there is increasing interest in restricting overall carbohydrate intake to treat metabolic disease or achieve ketogenesis. Very little is known about nutrition-physical activity interactions with this type of intervention.
This study will prescribe 3 diets to healthy males for 3 days in a randomised crossover design, where each participant will consume each of the diets. All food will be prepared and provided by the study team. The diets are as follows:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
- Conditions
- Physical Activity
- Being tested
- Diet
- Keywords
- Nutrition, Carbohydrates, Ketogenic, Metabolism
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
| Study group | Role | What they receive |
|---|---|---|
| MODSUG | Active comparator | Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Receives: Other: Diet |
| LOWSUG | Experimental | Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat Receives: Other: Diet |
| LOWCHO | Experimental | Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity energy expenditure (kj/day or kcal/day)
Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)
Measured: 3 days
Secondary outcomes (17)
Time spent in different physical activity intensities (MET categories) (minutes)
Time spent in different physical activity intensities (MET categories) (minutes) using individually-calibrated combined heart rate and accelerometry
Measured: 3 days
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) using individually-calibrated combined heart rate and accelerometry
Measured: 3 days
Energy expended in the postprandial period (kJ or kcal)
Energy expended in the postprandial period (kJ or kcal) measured using individually-calibrated combined heart rate and accelerometry
Measured: 3 days
Fasting blood glucose concentrations
Measures of blood glucose concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood insulin concentrations
Measures of blood insulin concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood triglyceride concentrations
Measures of blood triglyceride concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood non-esterified fatty acid concentrations
Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood lactate concentrations
Measures of blood lactate concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood beta-hydroxybutyrate concentrations
Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood leptin concentrations
Measures of blood leptin concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood fibroblast growth factor-21 concentrations
Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood total cholesterol concentrations
Measures of blood total cholesterol concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood high density lipoprotein concentrations
Measures of blood high density lipoprotein concentrations pre- and post-intervention.
Measured: 3 days
Fasting blood low density lipoprotein concentrations
Measures of blood low density lipoprotein concentrations pre- and post-intervention.
Measured: 3 days
Food preference ratings
Food preference ratings determined by computer task measured pre- and post-intervention
Measured: 3 days
Subjective appetite and mood ratings
Measured by 0-100 mm visual analogue scales measured pre- and post-intervention
Measured: 3 days
Blood pressure
Blood pressure using an automated sphygmomanometer pre- and post-intervention
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Jan 2018
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Model description
- Randomised crossover design
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917810
- Sponsor's protocol ID
- EP 17/18 219
- Status last verified
- May 2022
- First submitted
- 10 Apr 2019
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
PubMed 29028272Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
PubMed 24898233
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
- ClinicalTrials.gov ID
- NCT03917810
- Acronym / sponsor ID
- EP 17/18 219
- Conditions
- Physical Activity
- Keywords
- Nutrition, Carbohydrates, Ketogenic, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Apr 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.
Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured.
Each participant will undergo 3 days of each diet:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Detailed description
Guidelines calling for dietary free sugars to be reduced have been formulated from evidence that diets high in sugar are associated with high energy intake. In theory, by reducing the intake of sugars, calorie surplus will be reduced and energy balance will be maintained. However, when referring to interventions/behaviours that influence energy balance, both sides of the energy balance equation need to be considered. Alterations in nutrients may influence aspects of energy expenditure, not solely energy intake, and this may have implications for the efficacy of guidelines seeking to influence energy intake.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Furthermore, there is increasing interest in restricting overall carbohydrate intake to treat metabolic disease or achieve ketogenesis. Very little is known about nutrition-physical activity interactions with this type of intervention.
This study will prescribe 3 diets to healthy males for 3 days in a randomised crossover design, where each participant will consume each of the diets. All food will be prepared and provided by the study team. The diets are as follows:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised crossover design
| Arm | Type | Receives |
|---|---|---|
| MODSUG | Active comparator | Other: DietDiet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat |
| LOWSUG | Experimental | Other: DietDiet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat |
| LOWCHO | Experimental | Other: DietDiet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Male
- Able and willing to provide informed consent and safely comply with study procedures
- No anticipated changes in physical activity during the study (e.g. holidays)
Key exclusion criteria (4 listed)
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)•Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (±3%)
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 |
|---|---|---|
| DietMacronutrient composition (specifically type and/or amount of carbohydrate) is manipulated | Other | LOWCHO, LOWSUG, MODSUG |
Primary outcome
Physical activity energy expenditure (kj/day or kcal/day)
Time frame: 3 days
Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)
17 secondary outcomes
Time spent in different physical activity intensities (MET categories) (minutes)
Time frame: 3 days
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
Time frame: 3 days
Energy expended in the postprandial period (kJ or kcal)
Time frame: 3 days
Fasting blood glucose concentrations
Time frame: 3 days
Fasting blood insulin concentrations
Time frame: 3 days
Fasting blood triglyceride concentrations
Time frame: 3 days
Fasting blood non-esterified fatty acid concentrations
Time frame: 3 days
Fasting blood lactate concentrations
Time frame: 3 days
Fasting blood beta-hydroxybutyrate concentrations
Time frame: 3 days
Fasting blood leptin concentrations
Time frame: 3 days
Fasting blood fibroblast growth factor-21 concentrations
Time frame: 3 days
Fasting blood total cholesterol concentrations
Time frame: 3 days
Fasting blood high density lipoprotein concentrations
Time frame: 3 days
Fasting blood low density lipoprotein concentrations
Time frame: 3 days
Food preference ratings
Time frame: 3 days
Subjective appetite and mood ratings
Time frame: 3 days
Blood pressure
Time frame: 3 days
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 4 May 2022.
- Background: PubMed 29028272Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
- Background: PubMed 24898233Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Physical Activity, run by University of Bath 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 5 inclusion and 4 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 4 May 2022. 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?
Physical activity energy expenditure (kj/day or kcal/day) (time frame: 3 days). 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 NCT03917810, which also lists 2 linked publications.
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 4 May 2022.