Department for Health, University of Bath
Bath, BA2 7AY, United Kingdom
NCT Number: NCT03574987
This study will investigate how dietary sugar and carbohydrates influence metabolism and health across a 12-week period, with a focus on physical activity. One third of participants will eat a diet with typical amounts of sugar and carbohydrate, one third of participants will eat a diet with sugar intake restricted, and the final third of participants will eat a diet where both sugar and total carbohydrates are restricted and replaced with fat.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Bath, BA2 7AY, United Kingdom
Sugar is perceived negatively, leading to government taxation and targets to reduce consumption. These actions have been taken based on the limited evidence that high-sugar diets are associated with greater total energy intake. However, energy intake is only one half of the energy balance equation (energy in vs energy out). Without considering energy expenditure, it is impossible to fully understand the effects of sugar on health. Removing dietary sugar or carbohydrates from the diet may influence energy balance through mechanisms other than energy intake - for example by reducing levels of physical activity.
Understanding dietary regulators of energy balance is more important than ever because diseases like obesity are a consequence of energy surplus (i.e. energy in > energy out). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the responses to manipulating dietary carbohydrate and sugar content on energy balance and health. This research will enable the public to make informed dietary choices about carbohydrate and sugar consumption.
To achieve this, healthy non-obese adults, aged 18-65 years will be recruited to take part in an intervention study with measures of energy intake, energy expenditure, metabolic health, gut microbiota, and appetite. All laboratory trials will take place at the University of Bath. Participants will be randomised to consume one of three diets for a period of 12 weeks, with laboratory visits at baseline, at week 4, and at week 12:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
Time frame: 7 days (across 12 weeks) - Primary outcome at week 4
24-hour physical activity energy expenditure (kJ/day or kcal/day)
Time frame: 7 days (across 12 weeks)
Time spent in different physical activity intensities (MET categories) (minutes)
Time frame: 7 days (across 12 weeks)
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Time frame: 12 weeks
Estimated using food diaries, 7 days each time concurrently measured with PAEE and 3 days per week for the rest of the intervention
Time frame: 12 weeks
Measured weekly using electric scales
Time frame: 12 weeks
Bone mineral density measured using dual x-ray absorptiometry
Time frame: 12 weeks
Bone mineral content measured using dual x-ray absorptiometry
Time frame: 12 weeks
Fat mass measured using dual x-ray absorptiometry
Time frame: 12 weeks
Fat-free mass measured using dual x-ray absorptiometry
Time frame: 12 weeks
Android fat mass measured using dual x-ray absorptiometry
Time frame: 12 weeks
Gynoid fat mass measured using dual x-ray absorptiometry
Time frame: 12 weeks
Resting metabolic rate will be measured using indirect calorimetry
Time frame: 12 weeks
Substrate oxidation will be measured using indirect calorimetry both at rest and during exercise
Time frame: 12 weeks
Waist and hip circumference will be measured using a tape measure
Time frame: 12 weeks
Measured daily using pedometers
Time frame: 12 weeks
Assessment of blood glucose, insulin, triglycerides, non-esterified fatty acids, lactate, beta-hydroxybutyrate, leptin, fibroblast growth factor-21, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, appetite hormone concentrations (including PYY, GLP-1, ghrelin)
Time frame: 4 hours (across 12 weeks)
Assessment of blood glucose, insulin, triglycerides, non-esterified fatty acids, lactate, beta-hydroxybutyrate, leptin, fibroblast growth factor-21, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, appetite hormone concentrations (including PYY, GLP-1, ghrelin)
Time frame: 12 weeks
Measured using an automated sphygmomanometer
Time frame: 12 weeks
Food preference ratings determined by bespoke computer software
Time frame: 12 weeks
Measured by 0-100 mm visual analogue scale
Time frame: 14 days (across 12 weeks)
Measured using research-grade freestyle libre glucose monitors. Measured pre-, during- and at the end of the intervention
Time frame: 12 weeks
Expression of a panel of genes related to glucose metabolism in adipose biopsies using real-time polymerase chain reaction
Time frame: 12 weeks
Expression of various proteins related to glucose metabolism in adipose biopsies via Western blot
Time frame: 12 weeks
Expression of a panel of genes related to glucose metabolism in muscle biopsies using real-time polymerase chain reaction
Time frame: 12 weeks
Expression of various proteins related to glucose metabolism in muscle biopsies via Western blot
Time frame: 12 weeks
Glycogen concentrations measured from vastus lateralis muscle samples
Time frame: 12 weeks
Faecal sample DNA and water will be used to determine taxonomic and functional diversity of microbes using transcriptomic techniques
Time frame: 12 weeks
Will be measured using handheld sticks
Time frame: 12 weeks
Will be measured across trial days
University of Bath
Other
The Effect of Dietary Carbohydrate Manipulation on All Major Aspects of Energy Balance: A 12-week Randomised Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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