Trial Review

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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
Sex
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
22/09/2017
Date of last participant enrolment
Anticipated
Actual
30/11/2017
Date of last data collection
Anticipated
Actual
22/12/2017
Sample size
Target
20
Accrual to date
Final
24
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
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
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
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
[email protected]
Contact person for public queries
Name 80275 0
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
[email protected]
Contact person for scientific queries
Name 80276 0
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
[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
SourceTitleYear of PublicationDOI
EmbasePostprandial glycine as a biomarker of satiety: A dose-rising randomised control trial of whey protein in overweight women.2022https://dx.doi.org/10.1016/j.appet.2021.105871
EmbaseIntra-pancreatic fat is associated with high circulating glucagon and GLP-1 concentrations following whey protein ingestion in overweight women with impaired fasting glucose: A randomised controlled trial.2024https://dx.doi.org/10.1016/j.diabres.2023.111084
N.B. These documents automatically identified may not have been verified by the study sponsor.