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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Carbohydrate Intolerance Other: Glucose Other: Glucose plus lactulose Other: Hot Rice Other: Cold Rice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Rice Prepared in Different Ways
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018


Arm Intervention/treatment
Low Salivary Amylase Activity
Glucose Glucose plus lactulose Hot Rice Cold Rice
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.

High Salivary Amylase Activity
Glucose Glucose plus lactulose Hot Rice Cold Rice
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Glycemic response [ Time Frame: 0-2 hours ]
    The incremental area under the blood glucose response curve

  3. Breath hydrogen response [ Time Frame: 0-6 hours ]
    Sum of breath hydrogen concentrations from the lowest in the first 3 hours to 6 hours.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667963


Locations
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Canada, Ontario
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C 2X3
Sponsors and Collaborators
University of Toronto
Glycemic Index Laboratories, Inc
Investigators
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Principal Investigator: Thomas MS Wolever, MD, PhD President, Medical Director

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Responsible Party: Thomas Wolever, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03667963    
Other Study ID Numbers: RIS protocol number 33593
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lactulose
Gastrointestinal Agents