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Completed

NCT Number: NCT03667963

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

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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Key information

Conditions

Carbohydrate Intolerance Glucose-Galactose Malabsorption

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories

Toronto, Ontario, M5C 2X3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose

Other

50g glucose dissolved in 250ml water

Glucose plus lactulose

Other

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

Hot Rice

Other

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

Cold Rice

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Glycemic Index Laboratories, Inc

Registry information

Official study title

Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Rice Prepared in Different Ways

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2018
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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