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

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ClinicalTrials.gov Identifier: NCT03667963
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
Thomas Wolever, University of Toronto

Tracking Information
First Submitted Date  ICMJE September 10, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE August 29, 2018
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Glycemic Index (GI) [ Time Frame: 0-2 hours ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • Carbohydrate malabsorbed [ Time Frame: 0-6 hours. ]
    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.
  • Glycemic response [ Time Frame: 0-2 hours ]
    The incremental area under the blood glucose response curve
  • Breath hydrogen response [ Time Frame: 0-6 hours ]
    Sum of breath hydrogen concentrations from the lowest in the first 3 hours to 6 hours.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Cold and Hot Rice
Official Title  ICMJE Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Rice Prepared in Different Ways
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Carbohydrate Intolerance
Intervention  ICMJE
  • Other: Glucose
    50g glucose dissolved in 250ml water
  • Other: Glucose plus lactulose
    50g glucose plus 10g lactulose dissolved in 250ml water
  • Other: Hot Rice
    Freshly cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) and consumed hot.
  • Other: Cold Rice
    Cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) cooled overnight in a refrigerator and consumed cold.
Study Arms  ICMJE
  • Low Salivary Amylase Activity
    Glucose Glucose plus lactulose Hot Rice Cold Rice
    Interventions:
    • Other: Glucose
    • Other: Glucose plus lactulose
    • Other: Hot Rice
    • Other: Cold Rice
  • High Salivary Amylase Activity
    Glucose Glucose plus lactulose Hot Rice Cold Rice
    Interventions:
    • Other: Glucose
    • Other: Glucose plus lactulose
    • Other: Hot Rice
    • Other: Cold Rice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 21, 2018
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03667963
Other Study ID Numbers  ICMJE RIS protocol number 33593
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Wolever, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE Glycemic Index Laboratories, Inc
Investigators  ICMJE
Principal Investigator: Thomas MS Wolever, MD, PhD President, Medical Director
PRS Account University of Toronto
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP