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Completed

NCT Number: NCT03574987

Dietary Carbohydrate Manipulation and Energy Balance: RCT

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

About this study

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:

  • CONTROL (moderate sugar) - reflecting the composition of a typical European diet
  • Low sugar - the same composition of a typical European diet but with <5% energy intake from sugar
  • Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar, replacing carbohydrate energy with fat

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index 18.5-29.9 kg∙m-2
  • Age 18-65 years
  • Able and willing to provide informed consent and safely comply with study procedures
  • Females to maintain record of regular menstrual cycle phase/contraceptive use
  • No anticipated changes in physical activity during the first 4 weeks of the study (e.g. holidays or training programmes)

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%)
  • Use of antibiotic medication in the last 3 months
  • Use of prebiotic or probiotic products in the last month

Treatment and study plan

Diet

Other

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

Primary outcomes

  1. Physical Activity Energy Expenditure (kJ/Day or kcal/Day)

    Time frame: 7 days (across 12 weeks) - Primary outcome at week 4

    24-hour physical activity energy expenditure (kJ/day or kcal/day)

Secondary outcomes

  1. Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes)

    Time frame: 7 days (across 12 weeks)

    Time spent in different physical activity intensities (MET categories) (minutes)

  2. Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal)

    Time frame: 7 days (across 12 weeks)

    Energy expended in different physical activity intensities (MET categories) (kJ or kcal)

  3. Energy Intake and Dietary Macronutrient Composition

    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

  4. Body Mass

    Time frame: 12 weeks

    Measured weekly using electric scales

  5. Bone Mineral Density

    Time frame: 12 weeks

    Bone mineral density measured using dual x-ray absorptiometry

  6. Bone Mineral Content

    Time frame: 12 weeks

    Bone mineral content measured using dual x-ray absorptiometry

  7. Fat Mass

    Time frame: 12 weeks

    Fat mass measured using dual x-ray absorptiometry

  8. Fat-free Mass

    Time frame: 12 weeks

    Fat-free mass measured using dual x-ray absorptiometry

  9. Android Fat Mass

    Time frame: 12 weeks

    Android fat mass measured using dual x-ray absorptiometry

  10. Gynoid Fat Mass

    Time frame: 12 weeks

    Gynoid fat mass measured using dual x-ray absorptiometry

  11. Resting Metabolic Rate

    Time frame: 12 weeks

    Resting metabolic rate will be measured using indirect calorimetry

  12. Substrate Oxidation

    Time frame: 12 weeks

    Substrate oxidation will be measured using indirect calorimetry both at rest and during exercise

  13. Waist and Hip Circumference

    Time frame: 12 weeks

    Waist and hip circumference will be measured using a tape measure

  14. Step Count

    Time frame: 12 weeks

    Measured daily using pedometers

  15. Fasting Metabolite/Hormone Profile

    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)

  16. Postprandial Metabolite/Hormone Profile

    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)

  17. Blood Pressure

    Time frame: 12 weeks

    Measured using an automated sphygmomanometer

  18. Food Preference Ratings

    Time frame: 12 weeks

    Food preference ratings determined by bespoke computer software

  19. Subjective Appetite and Mood Ratings

    Time frame: 12 weeks

    Measured by 0-100 mm visual analogue scale

  20. Interstitial Glucose Concentrations

    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

  21. Adipose Tissue Gene Expression

    Time frame: 12 weeks

    Expression of a panel of genes related to glucose metabolism in adipose biopsies using real-time polymerase chain reaction

  22. Adipose Tissue Protein Expression

    Time frame: 12 weeks

    Expression of various proteins related to glucose metabolism in adipose biopsies via Western blot

  23. Muscle Tissue Gene Expression

    Time frame: 12 weeks

    Expression of a panel of genes related to glucose metabolism in muscle biopsies using real-time polymerase chain reaction

  24. Muscle Tissue Protein Expression

    Time frame: 12 weeks

    Expression of various proteins related to glucose metabolism in muscle biopsies via Western blot

  25. Muscle Glycogen Concentrations

    Time frame: 12 weeks

    Glycogen concentrations measured from vastus lateralis muscle samples

  26. Gut Microbiome Characterisation

    Time frame: 12 weeks

    Faecal sample DNA and water will be used to determine taxonomic and functional diversity of microbes using transcriptomic techniques

  27. Urinary Acetoacetate Concentrations

    Time frame: 12 weeks

    Will be measured using handheld sticks

  28. Urine Urea Nitrogen Excretion

    Time frame: 12 weeks

    Will be measured across trial days

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

The Effect of Dietary Carbohydrate Manipulation on All Major Aspects of Energy Balance: A 12-week Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2018
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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