- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06544252
Pre-exercise Ingestion of a Low Glycaemic Index Rice-based Mixed Meal Increases Fat Oxidation and Endurance Running in a Hot-humid Environment
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to complete 10 km time-trial
Time Frame: Up to 1 hour
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat and carbohydrate oxidation
Time Frame: Up to 2 hours
|
A portable gas analyser (K5, COSMED, Italy) was used to measure the respiratory gas exchange. Prior to each experimental session, the device was calibrated according to the procedures outlined in the manufacturer's instructions. The mixing chamber measurements were performed for V̇O2, V̇CO2, and respiratory exchange ratio (RER) and were measured continuously throughout exercise trials. The average values for V̇O2 (L.min-1) and V̇CO2 (L.min-1) were calculated over the last 30-s of each 15-min interval during SS running and each 1 km of 10 km time-trial. Whole-body rates of CHO and fat oxidation (g.min-1) were calculated using intensity-dependent equations for moderate to high-intensity exercise (50 - 75% V̇O2max) that assume negligible protein contribution to energy expenditure (Jeukendrup and Wallis 2005): CHO oxidation (g.min-1): (4.210 x V̇CO2) - (2.962 x V̇O2) Fat oxidation (g.min-1): (1.695 x V̇O2) - (1.701 x V̇CO2) |
Up to 2 hours
|
|
Capillary blood glucose
Time Frame: Up to 5 hours
|
The capillary blood was sampled for blood glucose via a finger prick using a sterile, single-use lancet (Accu-Check Safe-T-Pro Plus; Roche Diagnostics) during fasting state (before meal consumption), postprandial period (at 15, 30, 60, 90, 120, 180-min intervals), steady-state running (at 10, 30, 45-min intervals), time-trial 10km running performance (at 5, 10km marks).
|
Up to 5 hours
|
|
Serum insulin
Time Frame: Up to 5 hours
|
The venous blood was sampled for insulin using 22G IV catheter insertion (Surflo IV Catheter, Terumo Med Corporation, Eklton, MD., USA) during fasting state (before meal consumption), postprandial period (at 30, 90, 180-min intervals), steady-state running (at 10, 30, 45-min intervals), time-trial 10km running performance (at 10 km marks).
|
Up to 5 hours
|
|
Serum cortisol
Time Frame: Up to 5 hours
|
The venous blood was sampled for cortisol using 22G IV catheter insertion (Surflo IV Catheter, Terumo Med Corporation, Eklton, MD., USA) during fasting state (before meal consumption), postprandial period (at 180-min interval), steady-state running (at 45-min interval), time-trial 10km running performance (at 10 km marks).
|
Up to 5 hours
|
|
Serum lactate
Time Frame: Up to 2 hours
|
The venous blood was sampled for lactate using 22G IV catheter insertion (Surflo IV Catheter, Terumo Med Corporation, Eklton, MD., USA) at postprandial period (at 180-min interval), steady-state running (at 10, 45-min intervals), time-trial 10 km running performance (at 10 km marks).
|
Up to 2 hours
|
|
Heart rate
Time Frame: Up to 2 hours
|
Heart rate was recorded using heart rate monitor (Garmin HRM-Run®; Olathe, KS, USA) throughout the running test.
|
Up to 2 hours
|
|
Thermoregulatory measure
Time Frame: Up to 2 hours
|
Rectal temperature (Tre), and skin temperature (Tsk) were continuously measured throughout the running exercise.
Tre was measured by self-inserting a disposable thermistor probe (YSI 400 series, Mallinckrodt Medical, Kansas City, Mo., USA) 12 cm beyond the anal sphincter.
Tsk was assessed at four distinct sites (left shoulder, left chest, right mid-thigh, and right mid-shin) using iButton temperature sensors (Maxim Integrated Products,Sunnyvale, CA., USA).
|
Up to 2 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USM/JEPeM/19010083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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