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Completed

NCT Number: NCT03509610

Acute Responses to Dietary Carbohydrate Manipulation

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 comprises just one half of the energy balance equation (e.g. balance = intake - expenditure). Without considering energy expenditure, it is impossible to understand the effects of sugar on health. Sugar, and perhaps total carbohydrate intake, may be important for energy balance - perhaps by stimulating increased energy expenditure.

Understanding dietary regulators of energy balance is more important than ever before, because diseases like obesity are a consequence of energy surplus (i.e. energy intake > energy expenditure). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the acute (e.g. 24-hour) responses to manipulating dietary carbohydrate and sugar content on energy balance and health.

This research will contribute to enabling individuals to make informed dietary choices about carbohydrate and sugar consumption.

To achieve this, healthy non-obese adults will be recruited to a randomised crossover study. Measures of energy intake, energy expenditure, metabolic health, appetite, food preference, and gut microbiota will be taken. All laboratory trials will take place at the University of Bath.

Three diets will be investigated:

1. Control - reflecting the composition of a typical European diet 2. Low sugar - the same composition of a typical European diet but with <5% energy intake from sugar 3. Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat

The study will consist of a 3-day lead-in period with the control diet followed by one trial day with each diet.

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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

Dietary sugar is increasingly perceived in a negative way. This has led to taxation by government and guidelines by global public health bodies to reduce sugar intake to <5% of energy intake. All available public health guidelines regarding sugar advocate a reduction in sugar intake, despite a lack of evidence to support these recommendations. These guidelines focus on the association between sugar intake and energy intake, without regard for energy expenditure. This oversimplifies situations in which energy surplus is pathological, for example in diseases like obesity. This complexity is demonstrated by evidence that dietary sugar intake is decreasing in the United Kingdom, whilst rates of obesity have increased in the same timeframe.

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.

Carbohydrate availability dictates the capacity to perform physical work. However, the role of carbohydrate in regulating physical activity behaviours has only recently been considered. Ingestion of a carbohydrate-rich breakfast causes a significant increase in 24-hour PAEE compared with no breakfast consumption before midday. The magnitude of this difference is greatest prior to midday, near to when carbohydrate had been ingested and when glucose uptake to peripheral tissue is increased. This points towards a stimulatory role of carbohydrate or sugar on PAEE when carbohydrate is readily available to peripheral tissue. The amount of carbohydrate present in skeletal muscle is dictated by the amount of carbohydrate in the diet. As physical activity is performed by skeletal muscle, dietary carbohydrate intake may regulate physical activity behaviour. Consequently, reducing total carbohydrate intake may result in reduced PAEE.

Studies in which carbohydrate has been manipulated and physical activity has been measured have not been sufficient in answering this research question. Often self-report measures of physical activity are used, which are not sensitive enough to discern meaningful differences. Studies which have measured physical activity objectively, i.e. using pedometers or accelerometers, are confounded by a lack of information about actual carbohydrate intake or concurrent prescription of exercise interventions. Furthermore, government targets of reduced sugar intake to <5% of total energy intake are not aimed at overall carbohydrate intake per se. In the breakfast study mentioned, sugar intake was significantly greater amongst individuals who ate breakfast compared with individuals who fasted until midday. Therefore, it is also plausible that a regulatory role of carbohydrate on PAEE may be due to the type of carbohydrate rather than the absolute amount.

If the availability of carbohydrate to peripheral tissue plays a regulatory role on PAEE, then theoretically the effects of manipulating the amount or type of carbohydrate will be detectable acutely, within 24 hours.

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 or contraceptive use
  • No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)

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%)

Treatment and study plan

Diet

Other

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

Primary outcomes

  1. 24-hour physical activity energy expenditure (kcal/day)

    Time frame: 24 hours

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

Secondary outcomes

  1. 24-hour energy intake (kcal/day)

    Time frame: 24 hours

    24-hour energy intake (kcal/day)

  2. Fasting glucose concentrations

    Time frame: 24 hours

    Fasting glucose concentrations in serum samples

  3. Postprandial glucose concentrations

    Time frame: 24 hours

    Postprandial glucose concentrations in serum samples

  4. Fasting insulin concentrations

    Time frame: 24 hours

    Fasting insulin concentrations in serum samples

  5. Postprandial insulin concentrations

    Time frame: 24 hours

    Postprandial insulin concentrations in serum samples

  6. Fasting triglyceride concentrations

    Time frame: 24 hours

    Fasting and postprandial triglyceride concentrations determined in plasma samples

  7. Postprandial triglyceride concentrations

    Time frame: 24 hours

    Postprandial triglyceride concentrations in serum samples

  8. Fasting non-esterified fatty acid concentrations

    Time frame: 24 hours

    Fasting non-esterified fatty acid concentrations in serum samples

  9. Postprandial non-esterified fatty acid concentrations

    Time frame: 24 hours

    Postprandial non-esterified fatty acid concentrations in serum samples

  10. Fasting beta-hydroxybutyrate concentrations

    Time frame: 24 hours

    Fasting beta-hydroxybutyrate concentrations in serum samples

  11. Postprandial beta-hydroxybutyrate concentrations

    Time frame: 24 hours

    Postprandial beta-hydroxybutyrate concentrations in serum samples

  12. Subjective appetite

    Time frame: 24 hours

    Measured by 0-100 mm visual analogue scale

  13. Food preference ratings

    Time frame: 24 hours

    Food preference ratings determined by bespoke computer software

  14. Resting substrate oxidation

    Time frame: 24 hours

    Resting substrate oxidation determined by indirect calorimetry

  15. Postprandial substrate oxidation

    Time frame: 24 hours

    Postprandial substrate oxidation determined by indirect calorimetry

  16. Palatability

    Time frame: 24 hours

    Measured by 0-100 mm visual analogue scale

  17. Fasting cholesterol, HDL, and LDL concentrations

    Time frame: 24 hours

    Fasting cholesterol, HDL, and LDL concentrations in serum samples

  18. Postprandial cholesterol, HDL, and LDL concentrations

    Time frame: 24 hours

    Postprandial cholesterol, HDL, and LDL concentrations in serum samples

  19. Fasting leptin concentrations

    Time frame: 24 hours

    Fasting leptin concentrations in serum samples

  20. Postprandial leptin concentrations

    Time frame: 24 hours

    Postprandial leptin concentrations in serum samples

  21. Macronutrient intake

    Time frame: 24 hours

    Macronutrient intake across 24-h

  22. Fasting FGF21 concentrations

    Time frame: 24 hours

    Fasting FGF21 concentrations in serum samples

  23. Postprandial FGF21 concentrations

    Time frame: 24 hours

    Postprandial FGF21 concentrations in serum samples

  24. Eating rate

    Time frame: 24 hours

    Time taken to eat test meals

  25. Body mass

    Time frame: 24 hours

    Body mass

  26. Waist and hip circumference

    Time frame: 24 hours

    Waist and hip circumference, waist:hip ratio

  27. Fasting haematology profile

    Time frame: 24 hours

    Fasting haematology profile including WBC, RBC, HGB, haematocrit, platelet count

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

The Acute Responses to Manipulating Dietary Carbohydrate Content and Type on All Major Aspects of Energy Balance

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2018
Registry last updated
Jun 18, 2021

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.