HyperglycemiaNCT01804738
Investigating Inter-individual Variability in Glycemic and Insulin Responses
A study testing Jasmine rice and Parboiled basmati rice in people with Hyperglycemia and Insulin Sensitivity, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial summary
This study aims to test the following hypothesis in healthy lean young men: There are differences in glycemic response (GR) and insulin response (IR) between Chinese, Malay and Asian-Indian There are differences in GI values to the same food between ethnic groups There are ethnic differences postprandial GR and IR for… 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
- Hyperglycemia, Insulin Sensitivity
- What is being tested?
- Jasmine rice and Parboiled basmati rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2013to Jun 2014
- 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
- Be willing and able to comply with study procedures and given written informed consent
- Chinese/Malay/Indian males, aged 21-40 years old
- Body mass index (BMI) between 18.5 - 24.9 kg/m2
- Fasting blood glucose between 4 - 6 mmol/L
- Sedentary adults, with <1 episode of exercise per week
- Not have a history of food allergies or food intolerances
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- Be a non-smoker
- Drinks less than 3 units of alcohol per day
- Not taking antibiotics for the past 3 weeks
Who cannot join
- Subjects with known chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, and other significant medical conditions
- BMI <18.5 kg/m2 or >25 kg/m2
- Fasting blood glucose ≥7.0mmol/l
- Alcohol consumption >3 drinks / day
- Use of medications known to affect glucose metabolism
- Recent changes in weight of >5% over the past 3 months
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- Significant changes in diet over the past 3 months
- History of eating disorders or irregular eating habits
- Taking antibiotics medications over the past 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to test the following hypothesis in healthy lean young men:
- There are differences in glycemic response (GR) and insulin response (IR) between Chinese, Malay and Asian-Indian
- There are differences in GI values to the same food between ethnic groups
- There are ethnic differences postprandial GR and IR for high vs low GI foods
- Mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition influences inter-individual glycemic and insulinemic variability
- Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition determines the inter-ethnic glycemic and insulinemic variability
Read the detailed description
There is extensive evidence that numerous biological digestive factors varies between individuals and influence postprandial glycemic response (GR) and insulin response (IR), which are well established risk factors that precipitate the development of Type 2 diabetes mellitus (T2DM). However, no study to date has measured and compared physiological parameters such as mastication, salivary amylase activity, gastric emptying rates and gut microbiota in a multi-ethnic Asian population, with varying prevalence of obesity and T2DM. The aim of this study is to investigate ethnic differences in GR and IR as well as the GI values of foods. Additionally, we aim to examine how physiological digestive factors contribute to inter-ethnic and inter-individual variability in GR and IR. The study outcomes can potentially explain, in part, the varying susceptibility to obesity, T2DM and DM control between Chinese, Malays and Asian-Indians in Singapore, as reflected by the differences in prevalence of obesity, T2DM and DM control among the three local ethnic groups.
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Being tested
- Jasmine rice, Parboiled basmati rice
- Keywords
- Ethnic differences, Inter-individual variability, Glycemic response, Insulin response, Mastication, Salivary alpha-amylase, Gastric emptying, Metagenome
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jasmine riceOther
Standardised rice:cooking liquid ratio for 50g available carbohydrate portion
Parboiled basmati riceOther
Also called Dreamrice
Standardised rice:cooking liquid for 50g available carbohydrate portion
| Study group | Role | What they receive |
|---|---|---|
| Glucose | No intervention | Glucose anhydrous 50g dissolved in 250ml water |
| Jasmine rice | Active comparator | 50g available carbohydrate portion Receives: Other: Jasmine rice |
| Parboiled basmati rice | Active comparator | 50g available carbohydrate portion Receives: Other: Parboiled basmati rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic and insulin responses
Capillary bloods will be obtained using finger-pricks
Measured: Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption
Secondary outcomes (1)
Physiological digestive functions
They include: measurement of mastication rate, salivary amylase activity, gastric emptying rate and gut microbiota composition
Measured: Up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Yung Seng, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Yung S Lee, A/Prof, Principal investigator, Institute for Human Development and Potential (IHDP), Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804738
- Sponsor's protocol ID
- 2012/01149
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2013
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan VM, Ooi DS, Kapur J, Wu T, Chan YH, Henry CJ, Lee YS. The role of digestive factors in determining glycemic response in a multiethnic Asian population. Eur J Nutr. 2016 Jun;55(4):1573-81. doi: 10.1007/s00394-015-0976-0. Epub 2015 Jul 10.
PubMed 26160548Tan VM, Wu T, Henry CJ, Lee YS. Glycaemic and insulin responses, glycaemic index and insulinaemic index values of rice between three Asian ethnic groups. Br J Nutr. 2015 Apr 28;113(8):1228-36. doi: 10.1017/S0007114515000586. Epub 2015 Mar 19.
PubMed 25789978Ooi DS, Tan VM, Ong SG, Chan YH, Heng CK, Lee YS. Differences in AMY1 Gene Copy Numbers Derived from Blood, Buccal Cells and Saliva Using Quantitative and Droplet Digital PCR Methods: Flagging the Pitfall. PLoS One. 2017 Jan 26;12(1):e0170767. doi: 10.1371/journal.pone.0170767. eCollection 2017.
PubMed 28125683
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Inter-individual Variability in Glycemic and Insulin Responses
- ClinicalTrials.gov ID
- NCT01804738
- Acronym / sponsor ID
- 2012/01149
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Keywords
- Ethnic differences, Inter-individual variability, Glycemic response, Insulin response, Mastication, Salivary alpha-amylase, Gastric emptying, Metagenome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Mar 2013 (estimated)
- 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.
This study aims to test the following hypothesis in healthy lean young men:
- There are differences in glycemic response (GR) and insulin response (IR) between Chinese, Malay and Asian-Indian
- There are differences in GI values to the same food between ethnic groups
- There are ethnic differences postprandial GR and IR for high vs low GI foods
- Mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition influences inter-individual glycemic and insulinemic variability
- Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition determines the inter-ethnic glycemic and insulinemic variability
Detailed description
There is extensive evidence that numerous biological digestive factors varies between individuals and influence postprandial glycemic response (GR) and insulin response (IR), which are well established risk factors that precipitate the development of Type 2 diabetes mellitus (T2DM). However, no study to date has measured and compared physiological parameters such as mastication, salivary amylase activity, gastric emptying rates and gut microbiota in a multi-ethnic Asian population, with varying prevalence of obesity and T2DM. The aim of this study is to investigate ethnic differences in GR and IR as well as the GI values of foods. Additionally, we aim to examine how physiological digestive factors contribute to inter-ethnic and inter-individual variability in GR and IR. The study outcomes can potentially explain, in part, the varying susceptibility to obesity, T2DM and DM control between Chinese, Malays and Asian-Indians in Singapore, as reflected by the differences in prevalence of obesity, T2DM and DM control among the three local ethnic groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose | No intervention | –Glucose anhydrous 50g dissolved in 250ml water |
| Jasmine rice | Active comparator | Other: Jasmine rice50g available carbohydrate portion |
| Parboiled basmati rice | Active comparator | Other: Parboiled basmati rice50g available carbohydrate portion |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be willing and able to comply with study procedures and given written informed consent
- Chinese/Malay/Indian males, aged 21-40 years old
- Body mass index (BMI) between 18.5 - 24.9 kg/m2
- Fasting blood glucose between 4 - 6 mmol/L
- Sedentary adults, with <1 episode of exercise per week
Key exclusion criteria (9 listed)
- Subjects with known chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, and other significant medical conditions
- BMI <18.5 kg/m2 or >25 kg/m2
- Fasting blood glucose ≥7.0mmol/l
- Alcohol consumption >3 drinks / day
- Use of medications known to affect glucose metabolism
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 |
|---|---|---|
| Jasmine riceStandardised rice:cooking liquid ratio for 50g available carbohydrate portion | Other | Jasmine rice |
| Parboiled basmati riceAlso: DreamriceStandardised rice:cooking liquid for 50g available carbohydrate portion | Other | Parboiled basmati rice |
Primary outcome
Postprandial glycemic and insulin responses
Time frame: Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption
Capillary bloods will be obtained using finger-pricks
1 secondary outcome
Physiological digestive functions
Time frame: Up to 5 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 14 Mar 2019.
- Results publication: PubMed 26160548Tan VM, Ooi DS, Kapur J, Wu T, Chan YH, Henry CJ, Lee YS. The role of digestive factors in determining glycemic response in a multiethnic Asian population. Eur J Nutr. 2016 Jun;55(4):1573-81. doi: 10.1007/s00394-015-0976-0. Epub 2015 Jul 10.
- Results publication: PubMed 25789978Tan VM, Wu T, Henry CJ, Lee YS. Glycaemic and insulin responses, glycaemic index and insulinaemic index values of rice between three Asian ethnic groups. Br J Nutr. 2015 Apr 28;113(8):1228-36. doi: 10.1017/S0007114515000586. Epub 2015 Mar 19.
- Results publication: PubMed 28125683Ooi DS, Tan VM, Ong SG, Chan YH, Heng CK, Lee YS. Differences in AMY1 Gene Copy Numbers Derived from Blood, Buccal Cells and Saliva Using Quantitative and Droplet Digital PCR Methods: Flagging the Pitfall. PLoS One. 2017 Jan 26;12(1):e0170767. doi: 10.1371/journal.pone.0170767. eCollection 2017.
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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.
Yung S Lee, A/Prof principal investigator
Institute for Human Development and Potential (IHDP), Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jasmine rice and Parboiled basmati rice in people with Hyperglycemia and Insulin Sensitivity, run by Institute for Human Development and Potential (IHDP), Singapore 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 9 inclusion and 9 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 14 Mar 2019. 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?
Postprandial glycemic and insulin responses (time frame: Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption). 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 NCT01804738, which also lists 3 linked publications.
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 14 Mar 2019.