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Trial registered on ANZCTR


Registration number
ACTRN12618000145202
Ethics application status
Approved
Date submitted
16/01/2018
Date registered
31/01/2018
Date last updated
31/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of macronutrient interventions on diabetes- and appetite-related biomarkers in prediabetes, a randomised control trial.
Scientific title
Postprandial response of diabetes- and appetite-related biomarkers: macronutrient interventions in participants with prediabetes
Secondary ID [1] 293787 0
None
Universal Trial Number (UTN)
U1111-1198-6950
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 306184 0
Condition category
Condition code
Diet and Nutrition 305297 305297 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cross-over trial with a 7 day washout period where participants were given either a High dose protein drink 380mL with whey protein 50g, Low dose protein drink 380mL with whey protein 12.5g, or 380mL water on each of the 3 visits as their breakfast meal. Ad Lib lunch of pasta and tomato mince sauce were given to participants 4 hours after the breakfast treatment and were asked to eat as much as they can until comfortably full.
Intervention code [1] 300040 0
Treatment: Other
Comparator / control treatment
Water 380mL
Control group
Placebo

Outcomes
Primary outcome [1] 304459 0
blood samples for diabetes related biomarkers. Glucose, Insulin, C-peptide.
Timepoint [1] 304459 0
Time 0, 15, 30, 60, 90, 120, 180, 240, 270, 300, 360
Primary outcome [2] 304520 0
blood samples for appetite related biomarkers. PYY, CCK, GLP-1.
Timepoint [2] 304520 0
Time 0, 15, 30, 60, 90, 120, 180, 240, 270, 300, 360
Secondary outcome [1] 342018 0
Visual analogue scale (VAS) measuring appetite sensations
Timepoint [1] 342018 0
Time 0, 15, 30, 60, 90, 120, 180, 240, 270, 300, 360
Secondary outcome [2] 342019 0
Energy intake at ad lib lunch meal
Timepoint [2] 342019 0
Time = 240min. lunch is 4 hours after the protein drink

Eligibility
Key inclusion criteria
• Asian (Ethnic Chinese, incl. mainland China, Singapore, Malaysian, Hong Kong, Taiwan)
• Caucasian (Ethnic European)
• Female
• Aged 18-65 years
• BMI 23-40kg/m2
• Increased T2D risk; assessed by (i) glycaemic status as ‘Prediabetic’ with fasting plasma glucose (FPG) in the range of 5.6 – 6.9 mmol/L;
Minimum age
18 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Recent body weight loss/gain >10%, within previous 3 months or taking part in an active diet program.
• Low iron status, hence unsuitable for cannulation studies
• Current medications for weight loss or other conditions known to affect appetite
• Bariatric surgery
• Type 2 diabetes, or other significant current disease such as cardiovascular disease or cancer; or digestive disease including inflammatory bowel syndrome/disease (IBS/D), ulcerative colitis (UC), Crohn's disease
• Depression or any other anxiety disorder known to affect appetite
• Dislike or unwilling to consume food items included in the study or hypersensitivities or allergies to these foods (based on Food Preference Questionnaire)
• Smokers or ex-smokers who have given up smoking for less than 6 months
• Pregnant or breastfeeding women
• Unwilling/unable to comply with study protocol

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based upon a Latin square design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
This is a cross over study because all participants will take part in all 3 treatments.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A power analysis was performed to provide estimates of variance components using data from a previous test meal experiment performed at the Human Nutrition Unit which investigated the effect of a test breakfast on satiety and energy intake (EI) at an ad libitum lunch meal in a similar group of single gender of 18 women.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9493 0
New Zealand
State/province [1] 9493 0
Auckland

Funding & Sponsors
Funding source category [1] 298404 0
Government body
Name [1] 298404 0
NZ government National Science Challenge
Address [1] 298404 0
Building 505
85 Park Road, Grafton
Auckland, New Zealand
Country [1] 298404 0
New Zealand
Primary sponsor type
University
Name
University of Auckland Research Office
Address
Level 10, Building 620
49 Symonds St
Auckland 1010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 297537 0
None
Name [1] 297537 0
None
Address [1] 297537 0
None
Country [1] 297537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299399 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 299399 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299399 0
New Zealand
Date submitted for ethics approval [1] 299399 0
23/08/2017
Approval date [1] 299399 0
15/09/2017
Ethics approval number [1] 299399 0
17/NTA/172

Summary
Brief summary
People of Asian descent may be at much greater risk of poor metabolic health and diabetes at a younger age and a lower body weight than Europeans, Maori or Pacific people. The reason why some individuals may be more susceptible than others and what controls their diabetes risk may lie in the storage of body fat. Gaining even small amounts of body weight can lead to the fat ‘spilling over’ from adipose tissue and into important organs such as the pancreas, which in turn may significantly increase risk of disease. T2D is a nutritional disease and is able to be both prevented and treated through better nutrition. Macronutrients such as carbohydrates, lipids and protein can affect T2D biomarkers such as glucose and insulin, as well as the control of body weight. Considering overweight and obesity as the major risk factor for T2D, understanding mechanism that influence appetite control may play a significant role in preventing the onset of T2D. As part of the National Science Challenge, our research team is conducting acute clinical studies to assess if type and dose of macronutrients will affect biomarkers related to diabetes risk as well as those that are related to appetite control. The aim of this study is to assess the effect of dietary macronutrients given in different doses as part of a standardised breakfast drink on markers in your blood that relate to risk of diabetes; Appetite and food intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80274 0
Prof Sally Poppitt
Address 80274 0
University of Auckland Human Nutrition Unit,
18 Carrick Place,
Mt Eden,
Auckland 1024
Country 80274 0
New Zealand
Phone 80274 0
+6496305160
Fax 80274 0
Email 80274 0
s.poppitt@auckland.ac.nz
Contact person for public queries
Name 80275 0
Mr Wilson Yip
Address 80275 0
University of Auckland Human Nutrition Unit,
18 Carrick Place,
Mt Eden,
Auckland 1024
Country 80275 0
New Zealand
Phone 80275 0
+6496301162
Fax 80275 0
Email 80275 0
w.yip@auckland.ac.nz
Contact person for scientific queries
Name 80276 0
Mr Wilson Yip
Address 80276 0
University of Auckland Human Nutrition Unit,
18 Carrick Place,
Mt Eden,
Auckland 1024
Country 80276 0
New Zealand
Phone 80276 0
+6496301162
Fax 80276 0
Email 80276 0
w.yip@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary