HealthyNCT06544252

Pre-exercise Ingestion of a Low Glycaemic Index Rice-based Mixed Meal Increases Fat Oxidation and Endurance Running in a Hot-humid Environment

A study testing Low glycaemic index rice-based mixed meal (GI value = 47) and High glycaemic index rice-based mixed meal (GI value = 80) in people with Healthy and Trained Athletes, run by Universiti Sains Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy, Trained Athletes
What is being tested?: Low glycaemic index rice-based mixed meal (GI value = 47) and High glycaemic index rice-based mixed meal (GI value = 80)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteMalaysia
Study dates: 1 Jan 2022to 30 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Department of Community Health, Advanced Medical and Dental Institute
Kepala Batas, Pulau Pinang, 13200

Other trials in Malaysia

About this study

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.

Conditions: Healthy, Trained Athletes
Being tested: Low glycaemic index rice-based mixed meal (GI value = 47), High glycaemic index rice-based mixed meal (GI value = 80)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low glycaemic index rice-based mixed meal (GI value = 47)Dietary supplement
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 rice-based mixed meal (GI value = 80)Dietary supplement
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).

Study groups in NCT06544252
Study group	Role	What they receive
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 Receives: 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 Receives: Dietary Supplement: Low glycaemic index rice-based mixed meal (GI value = 47); Dietary Supplement: High glycaemic index rice-based mixed meal (GI value = 80)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 1 hour

Secondary outcomes (7)

Fat and carbohydrate oxidation
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)
Measured: Up to 2 hours
Capillary blood glucose
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).
Measured: Up to 5 hours
Serum insulin
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).
Measured: Up to 5 hours
Serum cortisol
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).
Measured: Up to 5 hours
Serum lactate
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).
Measured: Up to 2 hours
Heart rate
Heart rate was recorded using heart rate monitor (Garmin HRM-Run®; Olathe, KS, USA) throughout the running test.
Measured: Up to 2 hours
Thermoregulatory measure
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).
Measured: Up to 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202230 Jan 2023

First posted9 Aug 2024
Study start1 Jan 2022
Primary completion30 Jan 2023
Study completion30 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06544252
Sponsor's protocol ID: USM/JEPeM/19010083
Status last verified: Aug 2024
First submitted: 25 Jul 2024
Last updated: 9 Aug 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Private and confidential

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pre-exercise Ingestion of a Low Glycaemic Index Rice-based Mixed Meal Increases Fat Oxidation and Endurance Running in a Hot-humid Environment
ClinicalTrials.gov ID: NCT06544252
Acronym / sponsor ID: USM/JEPeM/19010083
Conditions: Healthy, Trained Athletes
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Universiti Sains MalaysiaUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 30 Jan 2023 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 9 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Low glycaemic index, Then high glycaemic index	Experimental	Dietary Supplement: Low glycaemic index rice-based mixed meal (GI value = 47), Dietary Supplement: High glycaemic index rice-based mixed meal (GI value = 80)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
High glycaemic index, Then low glycaemic index	Experimental	Dietary Supplement: Low glycaemic index rice-based mixed meal (GI value = 47), Dietary Supplement: High glycaemic index rice-based mixed meal (GI value = 80)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

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low glycaemic index rice-based mixed meal (GI value = 47)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).	Dietary supplement	High glycaemic index, Then low glycaemic index, Low glycaemic index, Then high glycaemic index
High glycaemic index rice-based mixed meal (GI value = 80)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).	Dietary supplement	High glycaemic index, Then low glycaemic index, Low glycaemic index, Then high glycaemic index

Primary outcome

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.

7 secondary outcomes

Fat and carbohydrate oxidation
Time frame: Up to 2 hours
Capillary blood glucose
Time frame: Up to 5 hours
Serum insulin
Time frame: Up to 5 hours
Serum cortisol
Time frame: Up to 5 hours
Serum lactate
Time frame: Up to 2 hours
Heart rate
Time frame: Up to 2 hours
Thermoregulatory measure
Time frame: Up to 2 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Individual participant dataSharing planned: No. Private and confidential

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahmad Munir Che Muhamed, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to complete 10 km time-trial (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06544252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.