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

Carbohydrate Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667963
• Other study ID #: RIS protocol number 33593
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: January 2019
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbohydrate Intolerance
• Carbohydrate Metabolism, Inborn Errors
• Malabsorption Syndromes

Intervention

Other:
• Glucose
50g glucose dissolved in 250ml water
• Glucose plus lactulose
50g glucose plus 10g lactulose dissolved in 250ml water
• Hot Rice
Freshly cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) and consumed hot.
• Cold Rice
Cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) cooled overnight in a refrigerator and consumed cold.

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Glycemic Index Laboratories, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-2 hours
Secondary	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.	0-6 hours.
Secondary	Glycemic response	The incremental area under the blood glucose response curve	0-2 hours
Secondary	Breath hydrogen response	Sum of breath hydrogen concentrations from the lowest in the first 3 hours to 6 hours.	0-6 hours