NCT03917810

Brief Summary

Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured. Each participant will undergo 3 days of each diet:

  1. 1.Moderate sugar - reflecting the composition of a typical European diet
  2. 2.Low sugar - similar macronutrient composition of a typical European diet but with \<5% energy intake from free sugars (as per government guidelines)
  3. 3.Low carbohydrate - low carbohydrate diet with \<5% energy intake from sugar and \<8% energy intake from carbohydrate, replacing carbohydrate energy with fat

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

April 10, 2019

Last Update Submit

May 2, 2022

Conditions

Physical Activity

Keywords

NutritionCarbohydratesKetogenicMetabolism

Outcome Measures

Primary Outcomes (1)

  • Physical activity energy expenditure (kj/day or kcal/day)

    Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)

    3 days

Secondary Outcomes (17)

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

    3 days

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

    3 days

  • Energy expended in the postprandial period (kJ or kcal)

    3 days

  • Fasting blood glucose concentrations

    3 days

  • Fasting blood insulin concentrations

    3 days

  • +12 more secondary outcomes

Study Arms (3)

MODSUG

ACTIVE COMPARATOR

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

Other: Diet

LOWSUG

EXPERIMENTAL

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

Other: Diet

LOWCHO

EXPERIMENTAL

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

Other: Diet

Interventions

DietOTHER

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

LOWCHOLOWSUGMODSUG

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index 18.5-29.9 kg∙m-2
  • Age 18-65 years
  • Male
  • Able and willing to provide informed consent and safely comply with study procedures
  • No anticipated changes in physical activity during the study (e.g. holidays)

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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related Publications (2)

  • 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: 29028272BACKGROUND

  • 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: 24898233BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 17, 2019

Study Start

January 1, 2018

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

GB(1)