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

• ClinicalTrials.gov Identifier: NCT03917810
• Recruitment Status: Suspended
• First Posted: April 17, 2019
• Last Update Posted: May 20, 2021
• Sponsor: University of Bath
• Information provided by (Responsible Party): Javier Gonzalez, University of Bath

Study Description

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

Study Design

• 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: January 1, 2022
• Estimated Primary Completion Date: September 1, 2022
• Estimated Study Completion Date: September 1, 2022

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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%)

Contacts and Locations

Locations

United Kingdom

University of Bath

Bath, Somerset, United Kingdom, BA2 7AY

Sponsors and Collaborators

University of Bath

More Information

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. Review.

Betts 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.

• Responsible Party: Javier Gonzalez, Senior Lecturer, University of Bath
• ClinicalTrials.gov Identifier: NCT03917810
• Other Study ID Numbers: EP 17/18 219
• First Posted: April 17, 2019
• Last Update Posted: May 20, 2021
• Last Verified: May 2021

• 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