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Glycaemic ResponseNCT03484858

The Effects of Exercise on Glycaemic Response of Low or High Glycaemic Index Meals

A study testing High glycaemic index meal and exercise, High glycaemic index meal and rest and Low glycaemic index meal and exercise in people with Glycaemic Response, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

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

The aim of the current study is to determine the effect of sprint interval training (SIT) in conjunction with either high or low glycaemic index meals (breakfast, lunch and dinner) on the 24-hour glycaemic profile and glucoregulatory hormones in Asian males. Read more about this study

Who is it for?
Ages 21 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Glycaemic Response
What is being tested?
High glycaemic index meal and exercise, High glycaemic index meal and rest and Low glycaemic index meal and exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSingapore
Study dates
17 Dec 2015to Mar 2018
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 21 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male
  • Age between 21-40 years
  • Chinese Ethnicity
  • Body mass index between 17 - 25 kg m2
  • Fasting blood glucose (< 6 mmol/L)
  • Normal blood pressure (< 140/90 mmHg)
Show all 12Show fewer
  • Do not have metabolic diseases (such as diabetes, hypertension etc.)
  • Do not have glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Do not take prescription medication that may affect metabolism
  • Low activity level (≤ 60 min of moderate-intensity exercise weekly)
  • Do not intentionally restrict food intake
  • Do not have intolerances or allergies to test foods

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Clinical Nutrition Research Centre

    Singapore, 117599

Other trials in Singapore

About this study

The aim of the current study is to determine the effect of sprint interval training (SIT) in conjunction with either high or low glycaemic index meals (breakfast, lunch and dinner) on the 24-hour glycaemic profile and glucoregulatory hormones in Asian males.

Read the detailed description

The study will recruit 20 young healthy Asian men of Chinese descent. Subjects will visit our Clinical Nutrition Research Centre (CNRC) on 5 occasions: once for consenting, screening and familiarization with the exercise and testing equipment (screening), and four additional times, interspaced by a minimum of 3 days, to undergo a total of four study conditions. The four study trials combine SIT or rest and low or high GI diet in a 2 x 2 design, and will be assigned in randomized order: (RL) Rest and low GI, (SL) SIT and low GI, (RH) Rest and high GI, and (SH) SIT and high GI. The test conditions will have comparable foods with RL and SL diets comprising local foods of low glycaemic index and RH and SH diets comprising local foods of high glycaemic index. Randomization of study trials will be carried out using an online randomizer (www.randomizer.org/). In the SL and SH trials, subjects will perform a SIT bout consisting of alternating periods of low-resistance cycling (4 ½ minutes) and maximal effort all out cycling (30 sec Wingate test) for a total of 30 min (i.e. a total of 6 Wingate tests)*, whereas in the RL and RH trials, subjects will rest for the equivalent period of time (i.e. 30 min). For screening, potential subjects will come in the morning after an overnight fast. After obtaining informed consent, a series of screening tests will be conducted, including questionnaires (general health, physical activity and eating behaviour), anthropometry (height, weight, waist and hip circumference), blood pressure, resting heart rate, fasting blood glucose, HbA1c and body composition by air displacement plethysmography (BodPod, Cosmed, Rome, Italy). Following enrolment, subjects will undergo assessment of resting metabolic rate (RMR) for 30 minutes using a ventilated hood system (Quark CPET, Cosmed, Rome, Italy). RMR will be multiplied by a factor of 1.5 to approximate total energy requirement for weight maintenance. This will allow for tailoring the caloric content of the test meals to each subject's energy requirements. Thereafter, subjects will eat a small standardized breakfast and they will perform a 30-min SIT session to get familiarized with the exercise and the equipment. The total time required for screening will be around 2 hours. After the screening, subjects will be provided with a food diary to record all food intake on Day 1 and an activity diary to record all activities on Days 1 and 2 of the actual study trials (see below). Although only sedentary subjects will be recruited (=60 min of moderate-intensity exercise weekly), they will also be instructed to refrain from any vigorous activities during the three days before each study trials and throughout its duration. On Visits 2 to 5 (four experimental trials, in random order): Each of the four study visits will last for approximately 12 hours (spanning over 3 days), during which the following will take place: On Day 1, subjects will come to the Lab at around 4:00 pm to have the continuous glucose monitoring system (CGMS) inserted. CGMS will be used to measure 24 hour blood glucose concentrations. The sensor records interstitial blood glucose concentrations every five minutes. This will involve the insertion of a small sensor under the skin in the abdomen, which will be carried out by using a device that produces minimal pain and discomfort. After insertion, the stabilizing and calibration procedures will take 2 hours after which the subjects will go home with a standardized dinner to eat at around 7:00pm. Subjects will have to refrain from eating after 10:30pm and return to the CNRC the following morning (Day 2).On Day 2, subjects will report to the lab at 8:15 am following an overnight fast for the first of the four study conditions. Upon arrival, an indwelling catheter will be inserted into the antecubital fossa or forearm vein of one arm and will be kept patent. Blood samples will be obtained after the insertion of the catheter at 8:30 am (time = -30 min). Between 8:30 am and 9:00 am, subjects will either rest for 30 minutes or perform the SIT bout which will start with 4 ½ minutes of low-resistance cycling followed by 30 seconds of maximum effort, repeated for a total of 6 times*. During the SIT, subjects' ratings of perceived exertion (RPE) will be measured periodically using the Borg scale. At 9:00 am, blood samples will be collected (time = 0 min), after which breakfast (low or high GI) will be provided. After finishing breakfast, at 9:15 am, blood samples will be collected every 10 minutes for the first half hour and every 30 minutes for the remaining 3 hours at 15, 25, 35, 45, 75, 105, 135, 165, and 195 minutes. Before lunch is served at 12:45pm (time = 225 min), blood will be collected and again after lunch at 1:00 pm (time = 240 min), followed by blood collection every 10 minutes for the first half hour and every 30 minutes for the remaining 3 hours at 250, 260, 270, 300, 330, 360, 390, 420 and 450 minutes. After the last blood sample is collected at 4:30 pm, the catheter will be removed and the subjects will be discharged from the Lab. Subjects will be provided with the last test meal of the day (dinner) to eat at home at around 7:00pm. Throughout the day and at specific times, subjects will complete computerized visual analogue scales (VAS) on hunger and fullness. Blood samples will be used to measure fasting and postprandial concentrations of glucose and major glucoregulatory hormones like insulin and glucagon. C-peptide concentrations will be used to provide estimates of insulin secretion with mathematical modelling. Blood lactate will be determined before and after exercise to verify maximal exercise effort. On Day 3, subjects will come to the Lab at 8:30 am for final calibration and removal of the CGMS sensor. Subjects will come to the Lab for visits 3, 4, and 5 to perform the other 3 experimental trials, with at least 3 days wash-out in-between visits.

Being tested
High glycaemic index meal and exercise, High glycaemic index meal and rest, Low glycaemic index meal and exercise, Low glycaemic index meal and rest

What participants receive

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

  • High glycaemic index meal and exerciseOther

  • High glycaemic index meal and restOther

  • Low glycaemic index meal and exerciseOther

  • Low glycaemic index meal and restOther

Study groups in NCT03484858
Study groupRoleWhat they receive
High glycaemic index meal and exerciseOtherNot described
Receives: Other: High glycaemic index meal and exercise
High glycaemic index meal and restOtherNot described
Receives: Other: High glycaemic index meal and rest
Low glycaemic index meal and exerciseOtherNot described
Receives: Other: Low glycaemic index meal and exercise
Low glycaemic index meal and restOtherNot described
Receives: Other: Low glycaemic index meal and rest

What is being measured

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

  1. Glycaemic response

    Measured using continuous glucose monitoring system

    Measured: up to 24 hours

  2. Glycaemic response

    Venous blood obtained through cannula, analysed using COBAS Analyzer

    Measured: up to 8 hours

Secondary outcomes (2)
  1. Blood biochemistry

    Measure of plasma insulin, triglyceride, C-peptide, non-esterified fatty acid (NEFA) and lactate.

    Measured: up to 8 hours

  2. Hunger and satiety

    Assessed using Visual Analogue Scale (VAS)

    Measured: up to 8 hours

Timeline

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

  1. First posted2 Apr 2018
  2. Study start17 Dec 2015
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized cross over design
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484858
Sponsor's protocol ID
2015/01092
Other IDs
2015
Status last verified
Mar 2018
First submitted
26 Mar 2018
Last updated
2 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High glycaemic index meal and exercise, High glycaemic index meal and rest and Low glycaemic index meal and exercise in people with Glycaemic Response, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

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 12 inclusion and 0 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 2 Apr 2018. 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 Singapore. 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?

Glycaemic response (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Apr 2018.

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