NCT06544252

Brief Summary

The objective of this research is to determine the influence of low and high glycemic index Malaysian pre-exercise mixed meals on endurance exercise performance in a hot-humid environment. Glycemic index (GI) is a method used to classify CHO-containing foods based on their influence on postprandial blood glucose when compared to the response on blood glucose after ingesting the same amount of CHO from a reference food (glucose or bread). Low GI (LGI) foods are digested and absorbed more slowly as compared to high GI (HGI) foods, resulting in a stable rise in blood glucose levels. The participants were trained male endurance long-distance runners. On the day of experimental trials, they consumed pre-exercise rice-based mixed meal, either LGI or HGI 3 hours before endurance running exercise. After that, they ran for 45 minutes at constant running speed equivalent to 70% VO2peak, followed by 10km time-trial. The respiratory gases, blood measures, rectal and skin temperature were measured throughout the running test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable healthy

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, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

July 25, 2024

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to complete 10 km time-trial

    The participant was clearly instructed to complete the 10 km time-trial as quickly as possible. The 10 km time-trial commenced with a 30-s rolling start to the participant's 70% V̇O2peak speed, after which the participant could freely adjust the speed. Throughout the 10 km time-trial, the prevailing running velocity and time-lapse were blinded to the participant, and only information on the distance covered at 1 km intervals was verbally provided to the participant.

    Up to 1 hour

Secondary Outcomes (7)

  • Fat and carbohydrate oxidation

    Up to 2 hours

  • Capillary blood glucose

    Up to 5 hours

  • Serum insulin

    Up to 5 hours

  • Serum cortisol

    Up to 5 hours

  • Serum lactate

    Up to 2 hours

  • +2 more secondary outcomes

Study Arms (2)

Low glycaemic index, Then high glycaemic index

EXPERIMENTAL

The participants were randomised to receive pre-exercise low glycaemic index rice-based mixed meal followed by a cross-over with the high glycaemic index rice-based mixed meal after one week

Dietary Supplement: Low glycaemic index rice-based mixed meal (GI value = 47)Dietary Supplement: High glycaemic index rice-based mixed meal (GI value = 80)

High glycaemic index, Then low glycaemic index

EXPERIMENTAL

The participants were randomised to receive pre-exercise high glycaemic index rice-based mixed meal followed by a cross-over with the low glycaemic index rice-based mixed meal after one week

Dietary Supplement: Low glycaemic index rice-based mixed meal (GI value = 47)Dietary Supplement: High glycaemic index rice-based mixed meal (GI value = 80)

Interventions

The mixed meal consisted of Basmati rice, chicken, and green-leafy vegetables. The energy content of the mixed meal was based on the body mass of the participant. The amount of CHO was 1.3 g.kg-1 body mass (Burke et al. 2019), and the amount of protein given was 0.5 g.kg-1 per meal (Witard, Garthe and Phillips 2019).

High glycaemic index, Then low glycaemic indexLow glycaemic index, Then high glycaemic index

The mixed meal consisted of fragrant rice, chicken, and green-leafy vegetables.The energy content of the mixed meal was based on the body mass of the participant. The amount of CHO was 1.3 g.kg-1 body mass (Burke et al. 2019), and the amount of protein given was 0.5 g.kg-1 per meal (Witard, Garthe and Phillips 2019).

High glycaemic index, Then low glycaemic indexLow glycaemic index, Then high glycaemic index

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • age 18-35 years old
  • trained (peak oxygen consumption (V̇O2peak): ≥ 55 mL.kg-1.min-1)
  • training volume (\>150 min, ≥ three times per week)
  • competing at the national level
  • \>2-year of running experience
  • tier 2 (trained) or tier 3 (highly trained) runners (McKay et al. 2022)
  • no allergies to any test foods

You may not qualify if:

  • diagnosis of chronic diseases (i.e. diabetes mellitus, hypertension, cardiovascular disease)
  • bone, muscle or joint impairments
  • on medication
  • currently smoking
  • use of illicit drugs
  • use of dietary supplements
  • on any particular diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Community Health, Advanced Medical and Dental Institute

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Study Officials

  • Ahmad Munir Che Muhamed, PhD

    Department of Community Health, Advanced Medical and Dental Institute, Universiti Sains Malaysia, Bertam, 13200, Kepala Batas, Pulau Pinang, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The present study employed a randomised, single-blind, cross-over trial design consisting of two experimental trials separated by a one-week washout period to minimise carryover effects, conducted under hot-humid (32°C, 65% RH) conditions.. The participants were randomised into two groups, each comprising six participants. Six participants were randomised to receive low glycaemic index, and the other six participants received high glycaemic index pre-exercise dietary interventions, followed by a cross-over with the opposing dietary intervention after one week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 9, 2024

Study Start

January 1, 2022

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Private and confidential

Locations