Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001118594
Ethics application status
Approved
Date submitted
6/10/2015
Date registered
23/10/2015
Date last updated
27/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the satiety and blood glucose effects of formulated beverages in adults
Scientific title
Satiety and blood glucose measurement trial to determine the effects of formulated beverages with red grape skin extract in healthy adults
Secondary ID [1] 287619 0
Nil known
Universal Trial Number (UTN)
U1111-1173-3485
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appetite control 296425 0
Blood glucose response 296426 0
Condition category
Condition code
Diet and Nutrition 296690 296690 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The potential satiety ingredient, Oxifend Red Grape Extract (RGE) is sourced from New Zealand Extracts Ltd. The aim of this study is to compare 3 formulated beverages, without RGE (control), with low dose RGE (1.25g in 250mL serve) and with high dose RGE (2.5g in 250mL serve), on subjective appetite and blood glucose responses when consumed and over 4 hours. The study design will be double-blinded, placebo controlled, crossover, randomised and completely balanced. Participants will be randomised to consume the 3 formulated beverages (each beverage once during a single morning, taken 30 minutes before standard breakfast), with a washout period of 3 days to 1 week between beverages. The standard breakfast meals will be provided to the participants, which comprises of 60g Sanitarium toasted muesli and 150 ml skim milk. The sessions will be held at the Human Clinical Facility at Plant & Food Research, Palmerston North (meeting room), where participants will be comfortably seated and could bring their work or reading material to the sessions. The study investigators will be administering the intervention, who are also trained to collect finger-prick blood samples for glucose measurements. We have detailed procedures in place to ensure adherence to the intervention. Participants are provided with the study information sheet and requirements (e.g. fasting from 10pm onwards on days before each session) and procedures explained to them during face-to-face meeting.
Intervention code [1] 293012 0
Treatment: Other
Comparator / control treatment
Placebo - control beverage without the red grape extract. Other ingredients are water, sugar, soy protein isolate, inulin, sodium carboxymethylcellulose, blueberry flavour, potassium citrate, tricalcium phosphate and food colourings.
Control group
Placebo

Outcomes
Primary outcome [1] 296297 0
Significant differences in the subjective appetite ratings (composite primary outcome) between beverages - without, with low dose, with high dose RGE. Appetite ratings for feelings of hunger, fullness, satiety, desire to eat and prospective food consumption are measured using 100 mm visual analogue scales (VAS). For example, beverage with the high RGE dose may contribute to lower hunger, higher fullness, higher satiety, lower desire to eat and lower prospective food consumption ratings (analysed as repeated measures) than the control beverage.
Timepoint [1] 296297 0
Baseline (before consuming beverage), at 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after consuming the beverage. Standard breakfast is consumed at 30 minutes timepoint.
Secondary outcome [1] 318110 0
Differences in the change in blood glucose responses between beverages - without, with low dose, with high dose RGE.
Timepoint [1] 318110 0
Baseline (before consuming the beverage), at 30, 60, 45, 60, 90, 120 and 180 minutes after consuming the beverage.

Eligibility
Key inclusion criteria
Healthy male and female individuals, aged 18–60 years with BMI of 18.5–26 kg/m2 (or up to 30 kg/m2 if healthy, by self-report)
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women, smokers, on medication, on restrained diet, have food allergy or intolerance to soy, milk, cereals (gluten), nuts, sesame seeds.

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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/10/2015
Date of last participant enrolment
Anticipated
Actual
12/12/2016
Date of last data collection
Anticipated
Actual
23/12/2016
Sample size
Target
30
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 7211 0
New Zealand
State/province [1] 7211 0
Palmerston North

Funding & Sponsors
Funding source category [1] 292181 0
Government body
Name [1] 292181 0
Ministry of Business, Innovation and Employment (MBIE)
Country [1] 292181 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
The New Zealand Institute for Plant & Food Research Ltd
Address
Foods for Appetite Control Research Programme Leader
Plant & Food Research Lincoln
Canterbury Agriculture & Science Centre
Gerald Street
Lincoln 7608
Country
New Zealand
Secondary sponsor category [1] 290856 0
None
Name [1] 290856 0
None
Address [1] 290856 0
None
Country [1] 290856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293654 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293654 0
Ministry of Health
Ethics Department
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 293654 0
New Zealand
Date submitted for ethics approval [1] 293654 0
08/09/2015
Approval date [1] 293654 0
05/10/2015
Ethics approval number [1] 293654 0
Provisionally approved, further information submitted.

Summary
Brief summary
The aim of the study is to determine the effects of red grape extract (RGE) in breakfast beverages on subjective appetite and blood glucose responses. We hypothesise that RGE increases satiety effect of the beverage through the strong GLUT2 transporter inhibitor thus eliciting an ileal brake effect by inhibiting the uptake of glucose, which is measured by blood glucose concentrations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60842 0
Ms Irene Ho
Address 60842 0
Plant & Food Research
Food Industry Science Centre
Batchelar Road
Palmerston North 4474
Country 60842 0
New Zealand
Phone 60842 0
+6463556101
Fax 60842 0
Email 60842 0
[email protected]
Contact person for public queries
Name 60843 0
Dr Lee Huffman
Address 60843 0
Plant & Food Research
Food Industry Science Centre
Batchelar Road
Palmerston North 4474
Country 60843 0
New Zealand
Phone 60843 0
+6469537700
Fax 60843 0
Email 60843 0
[email protected]
Contact person for scientific queries
Name 60844 0
Dr Lee Huffman
Address 60844 0
Plant & Food Research
Food Industry Science Centre
Batchelar Road
Palmerston North 4474
Country 60844 0
New Zealand
Phone 60844 0
+6469537700
Fax 60844 0
Email 60844 0
[email protected]

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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
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