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

NCT ID: NCT03667963

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2018-12-21

Brief Summary

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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

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Conditions

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Carbohydrate Intolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Low Salivary Amylase Activity

Glucose Glucose plus lactulose Hot Rice Cold Rice

Group Type OTHER

Glucose

Intervention Type OTHER

50g glucose dissolved in 250ml water

Glucose plus lactulose

Intervention Type OTHER

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

Hot Rice

Intervention Type OTHER

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

Cold Rice

Intervention Type OTHER

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

Group Type OTHER

Glucose

Intervention Type OTHER

50g glucose dissolved in 250ml water

Glucose plus lactulose

Intervention Type OTHER

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

Hot Rice

Intervention Type OTHER

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

Cold Rice

Intervention Type OTHER

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

Interventions

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Glucose

50g glucose dissolved in 250ml water

Intervention Type OTHER

Glucose plus lactulose

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

Intervention Type OTHER

Hot Rice

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

Intervention Type OTHER

Cold Rice

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Thomas Wolever

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

President, Medical Director

Locations

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Glycemic Index Laboratories

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34293081 (View on PubMed)

Other Identifiers

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RIS protocol number 33593

Identifier Type: -

Identifier Source: org_study_id

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