NCT02605291

Brief Summary

This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation during exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

November 6, 2015

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle glycogen concentration after dietary macronutrient manipulation

    Muscle glycogen concentration will be measured after the dietary macronutrient manipulation intervention.

    Day 7 of all experimental arms

Secondary Outcomes (8)

  • Rate of fat oxidation at rest (g/min)

    For 20 min on Day 7 of all experimental arms

  • Rate of fat oxidation during exercise (g/min)

    During 60 min of exercise on day 7 of all experimental arms

  • Rate of carbohydrate oxidation at rest (g/min)

    For 20 min on Day 7 of all experimental arms

  • Rate of carbohydrate oxidation during exercise (g/min)

    During 60 min of exercise on day 7 of all experimental arms

  • Blood glucose concentration

    At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.

  • +3 more secondary outcomes

Study Arms (3)

Experimental arm 1

EXPERIMENTAL

One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing.

Other: Diet with a different macronutrient content AOther: Interval treadmill running exerciseOther: Steady state treadmill running exercise

Experimental arm 2

EXPERIMENTAL

One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing.

Other: Diet with a different macronutrient content BOther: Interval treadmill running exerciseOther: Steady state treadmill running exercise

Experimental arm 3

EXPERIMENTAL

One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing.

Other: Diet with a different macronutrient content COther: Interval treadmill running exerciseOther: Steady state treadmill running exercise

Interventions

A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.

Experimental arm 1

A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.

Experimental arm 2

A diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3.

Experimental arm 3

Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.

Experimental arm 1Experimental arm 2Experimental arm 3

Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.

Experimental arm 1Experimental arm 2Experimental arm 3

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health
  • Non-smoking - currently and for the past 5 years
  • Fitness - V̇O2max 40-60 ml/kg/min
  • Body mass index (20-25 kg/m2)

You may not qualify if:

  • Known or suspected intolerance to the dietary interventions or their stated ingredients.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Previous participation in this study.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • An employee of the sponsor or the study site or members of their immediate family.
  • Abnormal / extreme habitual dietary practice / intake
  • Recent (≤3 months) dietary practice that may be deemed as low and/or high in macronutrients will be excluded.
  • The taking of any prescribed medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport Exercise and Rehabilitation Sciences, University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Gareth A Wallis, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 16, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations