NCT01804738

Brief 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 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

March 4, 2013

Last Update Submit

March 12, 2019

Conditions

HyperglycemiaInsulin Sensitivity

Keywords

Ethnic differencesInter-individual variabilityGlycemic responseInsulin responseMasticationSalivary alpha-amylaseGastric emptyingMetagenome

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycemic and insulin responses

    Capillary bloods will be obtained using finger-pricks

    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

    Up to 5 hours

Other Outcomes (1)

  • Glycemic index values

    180 mins

Study Arms (3)

Glucose

NO INTERVENTION

Glucose anhydrous 50g dissolved in 250ml water

Jasmine rice

ACTIVE COMPARATOR

50g available carbohydrate portion

Other: Jasmine rice

Parboiled basmati rice

ACTIVE COMPARATOR

50g available carbohydrate portion

Other: Parboiled basmati rice

Interventions

Jasmine riceOTHER

Standardised rice:cooking liquid ratio for 50g available carbohydrate portion

Jasmine rice
Parboiled basmati riceOTHER

Standardised rice:cooking liquid for 50g available carbohydrate portion

Also known as: Dreamrice
Parboiled basmati rice

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Be a non-smoker
  • Drinks less than 3 units of alcohol per day
  • Not taking antibiotics for the past 3 weeks

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (3)

  • 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.

    PMID: 26160548RESULT

  • Tan 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.

    PMID: 25789978RESULT

  • Ooi 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.

    PMID: 28125683RESULT

MeSH Terms

Conditions

HyperglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Yung S Lee, A/Prof

    Institute for Human Development and Potential (IHDP), Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 5, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

SG(1)