Acute Responses to Dietary Carbohydrate Manipulation

NCT03509610 | Completed

• 1 other identifier: EP 17/18 87
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutrition and Energy Balance

Keywords

Nutrition; Carbohydrates

Outcome Measures

Primary Outcomes (1)

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

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

  24 hours

Secondary Outcomes (27)

• 24-hour energy intake (kcal/day)

  24 hours

• Fasting glucose concentrations

  24 hours

• Postprandial glucose concentrations

  24 hours

• Fasting insulin concentrations

  24 hours

• Postprandial insulin concentrations

  24 hours

Study Arms (3)

CONTROL

ACTIVE COMPARATOR

Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat

Other: Diet

LOW SUG

EXPERIMENTAL

Diet consisting of 50% carbohydrate (\<5% sugar), 15% protein, 35% fat

Other: Diet

LOW CHO

EXPERIMENTAL

Diet consisting of \<8% carbohydrate (\<5% sugar), 15% protein, \>77% fat

Other: Diet

Interventions

Diet OTHER

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

CONTROL; LOW CHO; LOW SUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 29028272 BACKGROUND

• 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.

  PMID: 24898233 BACKGROUND

• Erickson J, Sadeghirad B, Lytvyn L, Slavin J, Johnston BC. The Scientific Basis of Guideline Recommendations on Sugar Intake: A Systematic Review. Ann Intern Med. 2017 Feb 21;166(4):257-267. doi: 10.7326/M16-2020. Epub 2016 Dec 20.

  PMID: 27992898 BACKGROUND

• Hengist A, Davies RG, Rogers PJ, Brunstrom JM, van Loon LJC, Walhin JP, Thompson D, Koumanov F, Betts JA, Gonzalez JT. Restricting sugar or carbohydrate intake does not impact physical activity level or energy intake over 24 h despite changes in substrate use: a randomised crossover study in healthy men and women. Eur J Nutr. 2023 Mar;62(2):921-940. doi: 10.1007/s00394-022-03048-x. Epub 2022 Nov 3.

  PMID: 36326863 DERIVED

Related Links

• SACN 2015 Report on Carbohydrates and Health

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 26, 2018
• Study Start: December 4, 2017
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

GB (1)