Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000027718
Ethics application status
Approved
Date submitted
18/11/2021
Date registered
14/01/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
14/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Different New Zealand Foods and Beverages on Energy Expenditure, Blood Sugar and Appetite After Eating
Scientific title
SYNERGY Acute Single-Product Sub-Study: The Utility of Individual NZ Origin Food and Beverage Products for the Acute Enhancement of Postprandial Thermogenesis, Glycaemia and Appetite in Healthy or Prediabetic Adults
Secondary ID [1] 305059 0
None
Universal Trial Number (UTN)
U1111-1268-7219
Trial acronym
Linked study record
This current study is a sub-study of the parent Synergy residential study: ACTRN12621000318886.

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 323269 0
Condition category
Condition code
Metabolic and Endocrine 320840 320840 0 0
Diabetes
Diet and Nutrition 320841 320841 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-centre repeated measure, randomised, cross-over design trial which will be conducted at the Human Nutrition Unit (HNU), University of Auckland. We will test the acute short term cardiometabolic effects following the consumption of four NZ origin food or beverage products, that may have beneficial cardiometabolic effects:
(i) a yoghurt
(ii) a fruit powder
(iii) a fruit drink
(iv) and kiwifruit
in four individual trials and compared to a matched comparator.

All four of these test products are commercially available branded "off-the-shelf" products which are readily available to the general public. However, to avoid bias that may occur due to un-blinding at this stage which could impact study outcomes, the investigators request that the specific product information is not made publicly available at this time.

The effects will be assessed in Asian Chinese and Caucasian participants identified with and without prediabetes. In each trial, participants will be randomised to receive either the test product or the matched placebo (which will be consumed under clinical monitoring) on two separate study visits, with a washout period of at least 2 days in between visits. Each study visit will last approximately 4-5 hours.
For some trials, the products will be incorporated as part of a standardised breakfast meal the morning of the study visit.
Intervention code [1] 321457 0
Prevention
Comparator / control treatment
The comparator products will be appearance- and energy-matched comparators of the test products i.e. all delivered as part of meals comprising off-the-shelf food and beverage products. For two of the four trials, the comparator products will be commercial "off-the-shelf" products readily available to the general public. For the other two trials, the comparator product will be either a formulated beverage (glucose + water) or an appearance- and taste-matched inactive control beverage (created specifically for study purposes and used previously in a study by Gibson et al. (2020) [Antioxidants 2020, 9, 316; doi:10.3390/antiox9040316]
Control group
Active

Outcomes
Primary outcome [1] 328636 0
Composite change in both fasted and postprandial resting energy expenditure (following consumption of product) assessed using indirect calorimetry
Timepoint [1] 328636 0
Fasting (t = -45 min - t = -15 min) and postprandial (t = 0 min - t = 180 min)
Primary outcome [2] 328637 0
Composite change in respiratory quotient (substrate utilisation)
Timepoint [2] 328637 0
Fasting (t = -45 min - t = -15 min) and postprandial (t = 0 min - t = 180 min)
Primary outcome [3] 328638 0
Change in venous blood glucose (collected from antecubital vein via cannula inserted at start of day)
Timepoint [3] 328638 0
Fasting (t = -45 min; t = -10 min) and postprandial (t = 15 min; t = 30 min; t = 45 min; t = 60 min; t = 90 min; t = 120 min; t = 150 min; t = 180 min)
Secondary outcome [1] 399787 0
Change in appetite using Visual Analogue Scale (VAS) Questionnaire (hunger, fullness, ability to eat, comfort, nausea)
Timepoint [1] 399787 0
Fasting (t = -45 min; t = -10 min) and postprandial (t = 15 min; t = 30 min; t = 45 min; t = 60 min; t = 75 min; t = 90 min; t = 120 min; t = 150 min; t = 180 min)
Secondary outcome [2] 399788 0
Assessment of Wellness using the Bond Lader Questionnaire (pleasantness, satisfaction, relaxedness, sleepiness, energy, and mental alertness)
Timepoint [2] 399788 0
Fasting (t = -45 min; t = -10 min) and postprandial (t = 15 min; t = 30 min; t = 45 min; t = 60 min; t = 75 min; t = 90 min; t = 120 min; t = 150 min; t = 180 min)
Secondary outcome [3] 399789 0
Ad libitum energy intake as measured by ad lib consumption of a standardised lunch meal at the research unit. All food items will be double weighed before and after the lunch meal and dietary analysis software will be used to calculate the amount of energy consumed.
Timepoint [3] 399789 0
Postprandial (t = 180 min)
Secondary outcome [4] 399791 0
Composite change in established plasma markers of obesity and type II diabetes (peptides: insulin, C-peptide, glucagon, GLP-1 and GIP; immune response: PBMCs, cytokines; hs-CRP; LFT; lipid panel: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides; amylin; adiponectin; thyroid hormones; PYY; CCK; ghrelin; amino acids)
Timepoint [4] 399791 0
Fasting (t = -45 min; t = -10 min) and postprandial (t = 15 min; t = 30 min; t = 45 min; t = 60 min; t = 90 min; t = 120 min; t = 150 min; t = 180 min)
Secondary outcome [5] 399792 0
Antioxidant status (measured by Square Wave Voltammetry)
Timepoint [5] 399792 0
Fasting (t = -10 min) and postprandial (t = 30 min; t = 180 min)
Secondary outcome [6] 399793 0
Blood pressure (measured by sphygmomanometer)
Timepoint [6] 399793 0
Fasting (t = -10 min) and postprandial (t = 30 min; t = 90 min; t = 150 min; t = 180 min)
Secondary outcome [7] 404058 0
Ad libitum macronutrient intake as measured by ad lib consumption of a standardised lunch meal at the research unit. All food items will be double weighed before and after the lunch meal and dietary analysis software will be used to calculate the proportion/amount of each macronutrient (fat, protein, carbohydrate) consumed.
Timepoint [7] 404058 0
Postprandial (t = 180 min)
Secondary outcome [8] 404059 0
Heart rate (measured using a chest heart rate monitor)
Timepoint [8] 404059 0
Continuous monitoring throughout study visit from t = -45 min to t = 180 min
Secondary outcome [9] 404060 0
Body temperature (measured using a Thermochron iButton peripherally attached to finger)
Timepoint [9] 404060 0
Continuous monitoring throughout study visit from t = -45 min to t = -180 min

Eligibility
Key inclusion criteria
• Male and female
• Asian Chinese or European Caucasian ethnicity
• 18-60 years old
• BMI between 24 and 40 kg/m2
• Fasting plasma glucose <6.9 mmol/L (in healthy or prediabetic range, in accordance with the American Diabetes Association classification of diabetes; ADA, 2014)
• Otherwise healthy, as according to self-report
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Type 1 or type 2 diabetes mellitus
• Medications controlling glycaemia
• Current or history of significant disease including cardiovascular disease; pancreatic disease, or other digestive diseases including inflammatory bowel syndrome/disease, ulcerative colitis, Crohn's disease; cancer
• Recent body weight loss/gain >10% within previous 3 months or taking part in an active diet program; or current medications for weight loss
• Previous bariatric surgery
• Current illness (including gastrointestinal or eating disorders)
• Taking any medication which might impact metabolic rate during the last 3 months
• Dietary, vitamin or mineral supplement consumption within last 7 days
• Smoker, current or in previous 6 months
• Recreational drug user, current or in previous 6 months
• Dislike or unwilling to consume food items included in the study, or hypersensitivities or allergies to these foods
• Unwilling/unable to comply with study protocol
• Participation in other clinical study, current or in previous 6 months
• Pregnant or breastfeeding women, current or in previous 6 months
• Considered unsuitable to participate by the PI
• Blood donation within previous 3 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The order in which each participants will receive the test product and the matched placebo, in each trial, will be generated using an Online Randomiser once the participants has been confirmed eligible and enrolled into the Trial.

Allocation is not concealed to the investigators, but allocation will be concealed to the participants throughout the study in all trials except the kiwifruit trial, for which allocation will be concealed up to administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
This current study forms a sub-study of the parent 'Synergy' residential study. The current study is comprised of four individual trials. In each trial, one of four NZ origin food or beverage products will be administered as the test product (i.e. yoghurt, fruit powder, fruit drink or kiwifruit). Each participant is only required to complete one of the four trials, however if they so wish they can freely choose to participate in 1, 2, 3 or 4 of the 4 individual trials.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA/linear mixed-models will be used to compare the acute changes in the outcome variables following consumption of the test and comparator product. The analysis will also look to determine differences between ethnicity (i.e. Caucasian European vs Asian Chinese) and glycaemic status (i.e. normoglycaemia vs prediabetes). Statistical significance will be set at p = 0.05 for all analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
23/06/2022
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
100
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 24046 0
New Zealand
State/province [1] 24046 0
Auckland

Funding & Sponsors
Funding source category [1] 309454 0
Government body
Name [1] 309454 0
New Zealand Ministry of Business, Innovation and Employment (MBIE), National Science Challenge: High Value Nutrition Programme
Country [1] 309454 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Level 10, Building 620
49 Symonds St
Auckland 1010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 310437 0
None
Name [1] 310437 0
Not applicable
Address [1] 310437 0
Not applicable
Country [1] 310437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309247 0
Health and Disability Ethics Committees
Ethics committee address [1] 309247 0
Ethics committee country [1] 309247 0
New Zealand
Date submitted for ethics approval [1] 309247 0
20/08/2021
Approval date [1] 309247 0
13/12/2021
Ethics approval number [1] 309247 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113482 0
Dr Jennifer Miles-Chan
Address 113482 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mount Eden
Auckland, 1024
Country 113482 0
New Zealand
Phone 113482 0
+64 096305160
Fax 113482 0
Email 113482 0
[email protected]
Contact person for public queries
Name 113483 0
Jack Penhaligan
Address 113483 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mount Eden
Auckland, 1024
Country 113483 0
New Zealand
Phone 113483 0
+64 096301162
Fax 113483 0
Email 113483 0
[email protected]
Contact person for scientific queries
Name 113484 0
Jack Penhaligan
Address 113484 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mount Eden
Auckland, 1024
Country 113484 0
New Zealand
Phone 113484 0
+64 096301162
Fax 113484 0
Email 113484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is in accordance to National Health and Disability Ethics Committee (HDEC) application that all data generated will only be used for this study only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12905Study protocol    These documents are currently awaiting approval by... [More Details]
12906Informed consent form    These documents are currently awaiting approval by... [More Details]
12907Ethical approval    These documents are currently awaiting approval by... [More Details]



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.