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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 : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, University of Bath

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date May 27, 2019
Estimated Study Start Date  ICMJE September 8, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03917810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
  • 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
  • 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
  • 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
  • Fasting blood glucose concentrations [ Time Frame: 3 days ]
    Measures of blood glucose concentrations pre- and post-intervention.
  • Fasting blood insulin concentrations [ Time Frame: 3 days ]
    Measures of blood insulin concentrations pre- and post-intervention.
  • Fasting blood triglyceride concentrations [ Time Frame: 3 days ]
    Measures of blood triglyceride concentrations pre- and post-intervention.
  • Fasting blood non-esterified fatty acid concentrations [ Time Frame: 3 days ]
    Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.
  • Fasting blood lactate concentrations [ Time Frame: 3 days ]
    Measures of blood lactate concentrations pre- and post-intervention.
  • Fasting blood beta-hydroxybutyrate concentrations [ Time Frame: 3 days ]
    Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.
  • Fasting blood leptin concentrations [ Time Frame: 3 days ]
    Measures of blood leptin concentrations pre- and post-intervention.
  • Fasting blood fibroblast growth factor-21 concentrations [ Time Frame: 3 days ]
    Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.
  • Fasting blood total cholesterol concentrations [ Time Frame: 3 days ]
    Measures of blood total cholesterol concentrations pre- and post-intervention.
  • Fasting blood high density lipoprotein concentrations [ Time Frame: 3 days ]
    Measures of blood high density lipoprotein concentrations pre- and post-intervention.
  • Fasting blood low density lipoprotein concentrations [ Time Frame: 3 days ]
    Measures of blood low density lipoprotein concentrations pre- and post-intervention.
  • Food preference ratings [ Time Frame: 3 days ]
    Food preference ratings determined by computer task measured pre- and post-intervention
  • Subjective appetite and mood ratings [ Time Frame: 3 days ]
    Measured by 0-100 mm visual analogue scales measured pre- and post-intervention
  • Blood pressure [ Time Frame: 3 days ]
    Blood pressure using an automated sphygmomanometer pre- and post-intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Official Title  ICMJE Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomised crossover design
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Physical Activity
Intervention  ICMJE Other: Diet
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
Study Arms  ICMJE
  • Active Comparator: MODSUG
    Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat
    Intervention: Other: Diet
  • Experimental: LOWSUG
    Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
    Intervention: Other: Diet
  • Experimental: LOWCHO
    Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat
    Intervention: Other: Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917810
Other Study ID Numbers  ICMJE EP 17/18 219
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javier Gonzalez, University of Bath
Study Sponsor  ICMJE University of Bath
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Bath
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP