NCT06400836

Brief Summary

Physical exercise (PE) significantly influences insulin sensitivity (IS), glucose control and overall metabolic health. While PE effectively enhances IS and glucose regulation, the timing of nutrient intake, before and after exercise, plays a crucial role in modulating its effects. The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate (CHO) ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period and the morning after during an oral glucose tolerance test (OGTT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 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 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

April 11, 2024

Last Update Submit

May 3, 2024

Conditions

Keywords

AthletesContinuous glucose monitoringExerciseMetabolismNutrition

Outcome Measures

Primary Outcomes (1)

  • To investigate change in glucose tolerance during a 75g glucose, 120 min oral glucose tolerance test (OGTT)

    To quantify participants' glucose tolerance, the change in plasma glucose levels (mmol/L) will be measured over a 120-minute period following the ingestion of a standardized 75g glucose solution during an OGTT.

    Comparing the change in glucose tolerance during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise, with carbohydrates consumed either before or after exercise.

Secondary Outcomes (1)

  • To investigate substrate oxidation during the oral glucose tolerance test (OGTT)

    Comparing the change in substrate oxidation during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise with carbohydrates being consumed either before or after exercise.

Other Outcomes (3)

  • To investigate performance capacity during a cycle ergometer time trial (TT).

    Comparing the change in performance capacity between the interventions involving carbohydrates being consumed either before (week 1) or after the time trial (week 2). Note that respective arm will be randomized.

  • To investigate substrate oxidation during 50 min submaximal evening exercise.

    Comparing the change in substrate oxidation between the interventions involving previous evening exercise with carbohydrates being consumed either before (week 1) or after exercise (week 2). Note that respective arm will be randomized.

  • To investigate nocturnal glucose regulation.

    Comparing the change in glucose levels (mmol/L) during the period 21:00-06:00 between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise, with CHO consumed either before or after exercise.

Study Arms (2)

Carbohydrate drink

ACTIVE COMPARATOR

All study participants will receive the carbohydrate (CHO) drink and the placebo in a randomized, doubleblind crossover fashion. The CHO drink and placebo products have similar appearance and taste.

Other: Carbohydrate timing - carbohydrate intake before or after exercise

Placebo

PLACEBO COMPARATOR

All study participants will receive the carbohydrate (CHO) drink and the placebo in a randomized, double-blind crossover fashion. The CHO drink and placebo products have similar appearance and taste.

Other: Carbohydrate timing - carbohydrate intake before or after exercise

Interventions

The study aims to investigate how pre- or post evening exercise carbohydrate ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period (21:00-06:00) and the morning after during an 120 minute oral glucose tolerance test (OGTT).

Carbohydrate drinkPlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females and males
  • years
  • Endurance fitness level of ≥40 mL O2/kg/min.
  • Signed informed consent

You may not qualify if:

  • Medical treatment and/or nutritional supplements that may affect glucose tolerance, substrate oxidation and performance capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutrition, and Sport Science, Centre for Health and Performance, University of Gothenburg, Gothenburg, Sweden

Gothenburg, Bohuslän, 405 30, Sweden

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stefan Pettersson, Assoc. Prof.

    Department of Food and Nutrition, and Sport Science, University of Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Participant, Investigator)
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment Randomised double-blind cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

May 6, 2024

Study Start

January 10, 2022

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations