Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000360819
Ethics application status
Approved
Date submitted
13/03/2012
Date registered
28/03/2012
Date last updated
29/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Postprandial glycaemia and satiety in Asian type 2 diabetics
Scientific title
Postprandial glycaemia and satiety in response to a rice and a rice mix meal in Asian people with type 2 diabetes
Secondary ID [1] 280108 0
Nil
Universal Trial Number (UTN)
U1111-1129-0183
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 286026 0
Condition category
Condition code
Diet and Nutrition 286215 286215 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 286216 286216 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is important for people with type 2 diabetes to keep blood glucose concentrations under control. Many Asians eat rice as a staple food and are reluctant to change dietary habits. We would bulk rice up with foods that elicit a smaller glycaemic response than the rice (beans, peas, corn grits, whole barley, whole oats) as an acceptable alternative to rice alone. Our hypothesis is that for equal sized portions, the mixed grains would elicit a smaller post-meal glycaemic response. The intervention will comprise participants consuming two cups of white rice or two cups of a rice mix that includes other grains and legumes. The meals will be consumed one week apart and the order that the meals will be eaten will be randomized to each participant. The meals will be cooked and served as an evening meal and consumed at the study premises.
Intervention code [1] 284438 0
Lifestyle
Comparator / control treatment
This is a crossover study in which each participant acts as his or her own control. Postprandial glycaemia measured three hours after eating a meal consisting of rice, other grains and legumes will be compared with postprandial glycaemia following the consumption of a meal of white rice. The comparator and control meals will have the same volume of two cups. There will be one week between treatments.
Control group
Active

Outcomes
Primary outcome [1] 286688 0
Postprandial blood glucose concentration as assessed by Hemocue glucose meter using capillary blood
Timepoint [1] 286688 0
Measurements taken at fixed intervals for 3 hours after eating. Capillary blood will be sampled before eating the meal (time 0 or baseline) and subsequently at 15, 30, 45, 60, 90, 120,150 and 180 min after eating.
Primary outcome [2] 286689 0
Postprandial satiety as assessed by visual analogue scale
Timepoint [2] 286689 0
Measurements taken at fixed intervals for 3 hours after eating. Visual analogue scales will be filled in before eating the meal (time 0 or baseline) and subsequently at 30, 60, 90, 120,150 and 180 min after eating.
Secondary outcome [1] 296464 0
Nil
Timepoint [1] 296464 0
Nil

Eligibility
Key inclusion criteria
Asian people living in Auckland, New Zealand diagnosed with type 2 diabetes mellitus
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of cardiovascular disease, cancer, or diseases of the gastrointestinal system. Diabetes mellitus requiring insulin.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
People on a diabetes register will be invited to participate. The person enrolling the participants will be unaware of which treatment (rice or the rice mix) the participant will be started on. Treatment allocation will be managed by another investigator based on a predetermined randomization. ie: as participants are enrolled he or she will receive a study ID from 1 to 36. The order in which each participant consumes the meals will be held on a computer remote from the person enrolling the participants. Eighteen of the participants will have rice as the first meal and 18 the rice mix as the first meal.
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 4192 0
New Zealand
State/province [1] 4192 0
Auckland

Funding & Sponsors
Funding source category [1] 284871 0
University
Name [1] 284871 0
University of Otago
Country [1] 284871 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] 283749 0
Hospital
Name [1] 283749 0
Greenlane Clinical Centre
Address [1] 283749 0
214 Green Lane West
One Tree Hill
Auckland 1051
Country [1] 283749 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286856 0
University of Otago Human Ethics Committee
Ethics committee address [1] 286856 0
Academic committees
PO Box 56
Dunedin 9054
Ethics committee country [1] 286856 0
New Zealand
Date submitted for ethics approval [1] 286856 0
Approval date [1] 286856 0
23/02/2012
Ethics approval number [1] 286856 0
1/12/0003

Summary
Brief summary
It is important for people with type 2 diabetes to keep blood glucose concentrations under control. Many Asians eat rice as a staple food and are reluctant to change dietary habits. We would bulk rice up with foods that elicit a smaller glycaemic response than the rice (beans, peas, corn grits, whole barley, whole oats) as an acceptable alternative to rice alone. Our hypothesis is that for equal sized portions, the mixed grains would elicit a smaller post-meal glycaemic response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33893 0
Address 33893 0
Country 33893 0
Phone 33893 0
Fax 33893 0
Email 33893 0
Contact person for public queries
Name 17140 0
Dr Bernard Venn
Address 17140 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 17140 0
New Zealand
Phone 17140 0
+6434795068
Fax 17140 0
+6434797958
Email 17140 0
[email protected]
Contact person for scientific queries
Name 8068 0
Dr Bernard Venn
Address 8068 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 8068 0
New Zealand
Phone 8068 0
+6434795068
Fax 8068 0
+6434797958
Email 8068 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.