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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03917810
Other study ID # EP 17/18 219
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date September 1, 2021

Study information

Verified date May 2022
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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%)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diet
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated

Locations

Country Name City State
United Kingdom University of Bath Bath Somerset

Sponsors (1)

Lead Sponsor Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 3 days
Secondary 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 3 days
Secondary 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 3 days
Secondary 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 3 days
Secondary Fasting blood glucose concentrations Measures of blood glucose concentrations pre- and post-intervention. 3 days
Secondary Fasting blood insulin concentrations Measures of blood insulin concentrations pre- and post-intervention. 3 days
Secondary Fasting blood triglyceride concentrations Measures of blood triglyceride concentrations pre- and post-intervention. 3 days
Secondary Fasting blood non-esterified fatty acid concentrations Measures of blood non-esterified fatty acid concentrations pre- and post-intervention. 3 days
Secondary Fasting blood lactate concentrations Measures of blood lactate concentrations pre- and post-intervention. 3 days
Secondary Fasting blood beta-hydroxybutyrate concentrations Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention. 3 days
Secondary Fasting blood leptin concentrations Measures of blood leptin concentrations pre- and post-intervention. 3 days
Secondary Fasting blood fibroblast growth factor-21 concentrations Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention. 3 days
Secondary Fasting blood total cholesterol concentrations Measures of blood total cholesterol concentrations pre- and post-intervention. 3 days
Secondary Fasting blood high density lipoprotein concentrations Measures of blood high density lipoprotein concentrations pre- and post-intervention. 3 days
Secondary Fasting blood low density lipoprotein concentrations Measures of blood low density lipoprotein concentrations pre- and post-intervention. 3 days
Secondary Food preference ratings Food preference ratings determined by computer task measured pre- and post-intervention 3 days
Secondary Subjective appetite and mood ratings Measured by 0-100 mm visual analogue scales measured pre- and post-intervention 3 days
Secondary Blood pressure Blood pressure using an automated sphygmomanometer pre- and post-intervention 3 days
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