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Carbohydrate IntoleranceNCT03667963

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

A study testing Glucose, Glucose plus lactulose and Hot Rice in people with Carbohydrate Intolerance, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Carbohydrate Intolerance
What is being tested?
Glucose, Glucose plus lactulose and Hot Rice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
29 Aug 2018to 21 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Glycemic Index Laboratories

    Toronto, Ontario, M5C 2X3

Other trials in Canada

About this study

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

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.

Being tested
Glucose, Glucose plus lactulose, Hot Rice, Cold Rice
Medical subject headings
Glucose-Galactose Malabsorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlucoseOther

    50g glucose dissolved in 250ml water

  • Glucose plus lactuloseOther

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

  • Hot RiceOther

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

  • Cold RiceOther

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

Study groups in NCT03667963
Study groupRoleWhat they receive
Low Salivary Amylase ActivityOtherGlucose Glucose plus lactulose Hot Rice Cold Rice
Receives: Other: Glucose; Other: Glucose plus lactulose; Other: Hot Rice; Other: Cold Rice
High Salivary Amylase ActivityOtherGlucose Glucose plus lactulose Hot Rice Cold Rice
Receives: Other: Glucose; Other: Glucose plus lactulose; Other: Hot Rice; Other: Cold Rice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0-2 hours

Secondary outcomes (3)

  1. 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.

    Measured: 0-6 hours.

  2. Glycemic response

    The incremental area under the blood glucose response curve

    Measured: 0-2 hours

  3. Breath hydrogen response

    Sum of breath hydrogen concentrations from the lowest in the first 3 hours to 6 hours.

    Measured: 0-6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start29 Aug 2018
  3. Primary completion21 Dec 2018
  4. Study completion21 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667963
Sponsor's protocol ID
RIS protocol number 33593
Status last verified
Jan 2019
First submitted
10 Sep 2018
Last updated
11 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34293081

Questions about this trial

What is this clinical trial studying?

A study testing Glucose, Glucose plus lactulose and Hot Rice in people with Carbohydrate Intolerance, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Index (GI) (time frame: 0-2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.

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