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Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure

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ClinicalTrials.gov Identifier: NCT03917810
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, University of Bath

Brief 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. Metabolic and appetite/mood responses to 3 days on each diet will be measured.

Each participant will undergo 3 days of each diet:

  1. Moderate sugar - reflecting the composition of a typical European diet
  2. Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
  3. Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat

Condition or disease Intervention/treatment Phase
Physical Activity Other: Diet Not Applicable

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:

  1. Moderate sugar - reflecting the composition of a typical European diet
  2. Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
  3. Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised crossover design
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Estimated Study Start Date : April 8, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MODSUG
Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat
Other: Diet
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated

Experimental: LOWSUG
Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
Other: Diet
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated

Experimental: LOWCHO
Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat
Other: Diet
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Time spent in different physical activity intensities (MET categories) (minutes) [ Time Frame: 3 days ]
    Time spent in different physical activity intensities (MET categories) (minutes) using individually-calibrated combined heart rate and accelerometry

  2. Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) [ Time Frame: 3 days ]
    Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) using individually-calibrated combined heart rate and accelerometry

  3. Energy expended in the postprandial period (kJ or kcal) [ Time Frame: 3 days ]
    Energy expended in the postprandial period (kJ or kcal) measured using individually-calibrated combined heart rate and accelerometry

  4. Fasting blood glucose concentrations [ Time Frame: 3 days ]
    Measures of blood glucose concentrations pre- and post-intervention.

  5. Fasting blood insulin concentrations [ Time Frame: 3 days ]
    Measures of blood insulin concentrations pre- and post-intervention.

  6. Fasting blood triglyceride concentrations [ Time Frame: 3 days ]
    Measures of blood triglyceride concentrations pre- and post-intervention.

  7. Fasting blood non-esterified fatty acid concentrations [ Time Frame: 3 days ]
    Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.

  8. Fasting blood lactate concentrations [ Time Frame: 3 days ]
    Measures of blood lactate concentrations pre- and post-intervention.

  9. Fasting blood beta-hydroxybutyrate concentrations [ Time Frame: 3 days ]
    Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.

  10. Fasting blood leptin concentrations [ Time Frame: 3 days ]
    Measures of blood leptin concentrations pre- and post-intervention.

  11. Fasting blood fibroblast growth factor-21 concentrations [ Time Frame: 3 days ]
    Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.

  12. Fasting blood total cholesterol concentrations [ Time Frame: 3 days ]
    Measures of blood total cholesterol concentrations pre- and post-intervention.

  13. Fasting blood high density lipoprotein concentrations [ Time Frame: 3 days ]
    Measures of blood high density lipoprotein concentrations pre- and post-intervention.

  14. Fasting blood low density lipoprotein concentrations [ Time Frame: 3 days ]
    Measures of blood low density lipoprotein concentrations pre- and post-intervention.

  15. Food preference ratings [ Time Frame: 3 days ]
    Food preference ratings determined by computer task measured pre- and post-intervention

  16. Subjective appetite and mood ratings [ Time Frame: 3 days ]
    Measured by 0-100 mm visual analogue scales measured pre- and post-intervention

  17. Blood pressure [ Time Frame: 3 days ]
    Blood pressure using an automated sphygmomanometer pre- and post-intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917810


Locations
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United Kingdom
University of Bath Recruiting
Bath, Somerset, United Kingdom, BA2 7AY
Contact: Aaron Hengist, BSc    +44 (0) 1225 385434    A.Hengist@bath.ac.uk   
Contact: Javier T Gonzalez, PhD    +44 (0) 1225 385518    J.T.Gonzalez@bath.ac.uk   
Sub-Investigator: Francoise Koumanov, PhD         
Sub-Investigator: Dylan Thompson, PhD         
Sub-Investigator: James A Betts, PhD         
Sponsors and Collaborators
University of Bath

Publications:
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Responsible Party: Javier Gonzalez, Senior Lecturer, University of Bath
ClinicalTrials.gov Identifier: NCT03917810     History of Changes
Other Study ID Numbers: EP 17/18 219
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Gonzalez, University of Bath:
Nutrition
Carbohydrates
Ketogenic
Metabolism