Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000519853
Ethics application status
Approved
Date submitted
15/05/2012
Date registered
16/05/2012
Date last updated
16/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Glycemic responses to glucose and rice in people of Chinese and European ethnicity
Scientific title
Determinants of postprandial glycaemia and glycaemic index of five rice varieties and a sucrose beverage in healthy people of Chinese or European descent
Secondary ID [1] 280485 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial glycaemia 286465 0
Condition category
Condition code
Diet and Nutrition 286722 286722 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 286723 286723 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Glycaemic Index (GI) provides a measure of a person’s rise in blood glucose following consumption of a test food relative to a reference food. Data from some observational studies suggest that consuming high GI food is a risk factor for obesity and type II diabetes. Although more than 60% of the world’s population with diabetes will come from Asia, studies of GI in Asian people are scarce. White rice is a staple food in Asia and a major determinant of GI in the Asian diet. In the clinical setting in New Zealand, dietitians recommend patients consume varieties of rice shown to have a low GI value. However, published GI values are largely obtained in other countries using non-Asian test subjects. The relevance of GI values determined in Caucasian people for Asian consumers is questionable because we have found ethnic differences in GI. The rice varieties to be tested are generally available in New Zealand supermarkets and are jasmine, parboiled, basmati, brown and Doongara. The sucrose is LoGiCane sugar. Testing will be undertaken over a period of 6 weeks. Test days will be non-consecutive and be undertaken 2 to 3 days per week. The trial is measuring the acute response of blood glucose immediately following a test meal served in portions containing 50g available carbohydrate. Equal numbers of male and female volunteers will be enrolled within age brackets (10 aged 18-30y, 10 aged 31-40y, and 10 aged 41-50y) for each ethnicity. The foods will be tested in sequence but the entry point of a participant into that sequence will be randomized. As such, ethnic-specific diet plans are not required although there are recommendations regarding standardisation of evening meals and exercise prior to each test day and exercise on the morning of the test day. Postprandial glycaemia will be measured using capillary blood and a Hemocue instrument. Extent of chewing will be determined by having the participants chew and expectorate a weighed sample and then rinsing over a laboratory sieve in order to measure the proportion of finely chewed rice. Saliva samples will be collected for the determination os salivary alpha-amylase activity using a proprietary kit.
Intervention code [1] 284852 0
Lifestyle
Comparator / control treatment
This is a study in which postprandial glycaemic responses and glycaemic index will be compared between ethnic groups for a number of foods. The European group will be considered as the control for the Chinese group.
Control group
Active

Outcomes
Primary outcome [1] 287120 0
Postprandial blood glucose concentration as assessed by Hemocue glucose meter using capillary blood
Timepoint [1] 287120 0
Measurements taken at fixed intervals for 2 hours after eating. Capillary blood will be sampled before eating the meal (time 0 or baseline) and subsequently at 15, 30, 45, 60, 90 and 120 min after eating.
Primary outcome [2] 287121 0
Glycaemic Index as assessed by Hemocue glucose meter using capillary blood. Glycaemic Index will be calculated as the ratio of postprandial incremental area under the blood glucose curve of a test food relative to a reference food.
Timepoint [2] 287121 0
Measurements taken at fixed intervals for 2 hours after eating. Capillary blood will be sampled before eating the meal (time 0 or baseline) and subsequently at 15, 30, 45, 60, 90 and 120 min after eating.
Primary outcome [3] 287122 0
Extent of chewing measured using a chewing/expectorating/sieving test.
Timepoint [3] 287122 0
The test will be conducted following the 2 hour postprandial blood glucose measurements.
Secondary outcome [1] 297438 0
Salivary alpha-amylase activity by obtaining saliva samples from participants both before and after chewing.
Timepoint [1] 297438 0
The test will be conducted both before and following the 2 hour postprandial blood glucose measurements.

Eligibility
Key inclusion criteria
Healthy people of Chinese descent both of whose parents were of the same race.
Healthy people of European descent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People diagnosed with chronic disease including diabetes mellitus, cardiovascular disease, cancer, and diseases of the digestive system; who are taking any medications that affect glucose tolerance; that suffer from food allergies; and women who are pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Equal numbers of male and female volunteers will be enrolled within age brackets (10 aged 18-30y, 10 aged 31-40y, and 10 aged 41-50y) for each ethnicity. The foods will be tested in sequence but the entry point of a participant into that sequence will be randomized. Enrolment of participants will be carried out before allocation of start date. Participants will be block randomized to ensure equal numbers of each ethnic group will be tested on the same day. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4319 0
New Zealand
State/province [1] 4319 0
Otago

Funding & Sponsors
Funding source category [1] 285246 0
University
Name [1] 285246 0
University of Otago
Country [1] 285246 0
New Zealand
Funding source category [2] 285247 0
University
Name [2] 285247 0
Riddet Institute
Country [2] 285247 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 284110 0
University
Name [1] 284110 0
Riddet Institute
Address [1] 284110 0
Massey University
Corner University Avenue and Orchard Road
Palmerston North 4442
Country [1] 284110 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287254 0
University of Otago Human Ethics Committee
Ethics committee address [1] 287254 0
Academic committees
PO Box 56
Dunedin 9054
Ethics committee country [1] 287254 0
New Zealand
Date submitted for ethics approval [1] 287254 0
Approval date [1] 287254 0
13/10/2009
Ethics approval number [1] 287254 0
1/09/0185

Summary
Brief summary
The aim of the project is to compare postprandial glycaemia and the glycaemic index of five types of rice and a sucrose product available in New Zealand between Chinese and Caucasian groups. Chewing and salivary alpha amylase activity will be tested as possible determinants of the postprandial response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34176 0
Address 34176 0
Country 34176 0
Phone 34176 0
Fax 34176 0
Email 34176 0
Contact person for public queries
Name 17423 0
Dr Bernard Venn
Address 17423 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 17423 0
New Zealand
Phone 17423 0
+6434795068
Fax 17423 0
+6434797958
Email 17423 0
[email protected]
Contact person for scientific queries
Name 8351 0
Prof Jim Mann
Address 8351 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 8351 0
New Zealand
Phone 8351 0
+6434797719
Fax 8351 0
+6434797958
Email 8351 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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