Clinical trial NCT03917810: Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Official title: Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Nutrition
Carbohydrates
Ketogenic
Metabolism
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised crossover design
Primary purpose: BASIC_SCIENCE

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

Eligibility 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%)

Primary outcomes:
measure: Physical activity energy expenditure (kj/day or kcal/day)
timeFrame: 3 days
Secondary outcomes:
measure: Time spent in different physical activity intensities (MET categories) (minutes)
timeFrame: 3 days
measure: Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
timeFrame: 3 days
measure: Energy expended in the postprandial period (kJ or kcal)
timeFrame: 3 days
measure: Fasting blood glucose concentrations
timeFrame: 3 days
measure: Fasting blood insulin concentrations
timeFrame: 3 days
measure: Fasting blood triglyceride concentrations
timeFrame: 3 days
measure: Fasting blood non-esterified fatty acid concentrations
timeFrame: 3 days
measure: Fasting blood lactate concentrations
timeFrame: 3 days
measure: Fasting blood beta-hydroxybutyrate concentrations
timeFrame: 3 days
measure: Fasting blood leptin concentrations
timeFrame: 3 days
measure: Fasting blood fibroblast growth factor-21 concentrations
timeFrame: 3 days
measure: Fasting blood total cholesterol concentrations
timeFrame: 3 days
measure: Fasting blood high density lipoprotein concentrations
timeFrame: 3 days
measure: Fasting blood low density lipoprotein concentrations
timeFrame: 3 days
measure: Food preference ratings
timeFrame: 3 days
measure: Subjective appetite and mood ratings
timeFrame: 3 days
measure: Blood pressure
timeFrame: 3 days
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
state: Somerset
Study officials:
References:
citation: 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.
citation: 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.