CClinicalTrials.gg
CompletedNCT03667963Updated Jan 11, 2019

Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Cold and Hot Rice

An interventional study of Glucose and Glucose plus lactulose in Carbohydrate Intolerance, sponsored by University of Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-11.

Sponsored by University of Toronto · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

This study evaluates the effect of different methods of preparation (cooked and consumed hot vs cooked, cooled overnight and consumed cold) and variation in the activity of salivary amylase on the glycemic index and carbohydrate digestibility in healthy human subjects. The effect of genetic variation in small intestinal starch digesting enzymes on glycemic index and starch digestibility will also be assessed.

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Conditions studied

  • Carbohydrate Intolerance
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In context

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males or non-pregnant females aged 18-75 years and in good health
  • Eligible to receive income in Canada
  • Have Ontario Health Insurance Plan or equivalent medical coverage.
  • Previous donor of saliva using protocol reference number # 31093 or GIL-1670 (in which subject consents to measurement of salivary amylase activity and genetic variation in AMY1, SI and MGAM genes).
  • Salivary amylase activity in the lowest tertile (\<50 U/ml) or highest tertile (>105 U/ml) of salivary amylase activity of 40 subjects previously measured.

Exclusion criteria

Exclusion Criteria:

  • known history of AIDS, hepatitis, diabetes or a heart condition
  • Allergy to rice, canola oil or sesame oil.
  • use of medications (including, but not limited to, insulin or other antidiabetic drugs, systemic steroids, antipsychotics, protease inhibitors, antivirals, immunosuppressive agents and drugs affecting gut motility or digestion) or with any condition which might, in the opinion of Dr. Wolever, the Medical Director or GI Labs, either: 1) make participation dangerous to the participant himself (or herself) or to others, or 2) affect the results.
  • individuals who cannot or will not comply with the experimental procedures or do not follow the instructions of GI Labs staff related to the safe performance of the experimental procedures
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Other
    Low Salivary Amylase Activity

    Glucose Glucose plus lactulose Hot Rice Cold Rice

    Other: Glucose · Other: Glucose plus lactulose · Other: Hot Rice · Other: Cold Rice

  • Other
    High Salivary Amylase Activity

    Glucose Glucose plus lactulose Hot Rice Cold Rice

    Other: Glucose · Other: Glucose plus lactulose · Other: Hot Rice · Other: Cold Rice

Interventions

  • OtherGlucose

    50g glucose dissolved in 250ml water

  • OtherGlucose plus lactulose

    50g glucose plus 10g lactulose dissolved in 250ml water

  • OtherHot Rice

    Freshly cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) and consumed hot.

  • OtherCold Rice

    Cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) cooled overnight in a refrigerator and consumed cold.

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What researchers measure

Primary outcomes

  1. Glycemic Index (GI)

    For each subject, the incremental area under the glucose response curve over 2 hours (iAUC) after each rice test meal is expressed as a percentage of the mean iAUC elicited by the 2 glucose test meals.

    Time frame: 0-2 hours

Secondary outcomes

  1. Carbohydrate malabsorbed

    For each test meal the sum of breath hydrogen concentrations from the lowest value over 0-3 hours to 6 hours (termed "H"). For each subject the amount of hydrogen per gram malabsorbed carbohydrate (H/g) is calculated as (GL-G)/10 where GL is H after the glucose plus lactose meal and G is H after the glucose meal. The amount of carbohydrate malabsorbed after the hot and cold rice meals, respectively, are HR/Hg and CR/Hg, where HR and Cr are H after the hot and cold rice meals.

    Time frame: 0-6 hours.

  2. Glycemic response

    The incremental area under the blood glucose response curve

    Time frame: 0-2 hours

  3. Breath hydrogen response

    Sum of breath hydrogen concentrations from the lowest in the first 3 hours to 6 hours.

    Time frame: 0-6 hours

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Study locations

1 site
  • Glycemic Index Laboratories
    Toronto, Ontario M5C 2X3, Canada
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References and documents

Publications

  • Wolever TMS, El-Sohemy A, Ezatagha A, Zurbau A, Jenkins AL. Neither low salivary amylase activity, cooling cooked white rice, nor single nucleotide polymorphisms in starch-digesting enzymes reduce glycemic index or starch digestibility: a randomized, crossover trial in healthy adults. Am J Clin Nutr. 2021 Nov 8;114(5):1633-1645. doi: 10.1093/ajcn/nqab228. PubMed 34293081 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03667963
Lead sponsor
University of Toronto
Collaborators
Glycemic Index Laboratories, Inc
Responsible party
Thomas Wolever (Professor, University of Toronto) — Principal investigator
First posted
Sep 12, 2018
Start date
Aug 29, 2018
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018
Last update
Jan 11, 2019

Study contacts

Thomas MS Wolever, MD, PhD
principal investigator · President, Medical Director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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