Dietary Carbohydrate Manipulation and Energy Balance: RCT

NCT03574987 | Completed Results

• 1 other identifier: CHEB-Intervention
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Activity; Diet Modification

Keywords

Physical Activity; Nutrition; Carbohydrates; Sugar; Energy Balance

Outcome Measures

Primary Outcomes (1)

• Physical Activity Energy Expenditure (kJ/Day or kcal/Day)

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

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

Secondary Outcomes (28)

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

  7 days (across 12 weeks)

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

  7 days (across 12 weeks)

• Energy Intake and Dietary Macronutrient Composition

  12 weeks

• Body Mass

  12 weeks

• Bone Mineral Density

  12 weeks

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/contraceptive use
• No anticipated changes in physical activity during the first 4 weeks of the study (e.g. holidays or training programmes)

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

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

• Bergwall S, Johansson A, Sonestedt E, Acosta S. High versus low-added sugar consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2022 Jan 5;1(1):CD013320. doi: 10.1002/14651858.CD013320.pub2.

  PMID: 34986271 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor Javier Gonzalez
• Organization: University of Bath

j.t.gonzalez@bath.ac.uk

0122538

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Randomised controlled trial with 3 arms. One arm is a typical diet (50% CHO, 20% SUG), one arm is low sugar (50% CHO, \<5% SUG), one arm is low carbohydrate (\<8% CHO, \<5% SUG). Stratified by sex and physical activity level (PAL).

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 2, 2018
• Study Start: October 1, 2018
• Primary Completion: February 11, 2022
• Study Completion: March 30, 2022
• Last Updated: June 17, 2024
• Results First Posted: June 17, 2024

Record last verified: 2024-01

Locations

GB (1)