Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000209099
Ethics application status
Approved
Date submitted
9/03/2010
Date registered
15/03/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo controlled trial of the effect of functional beverages on blood pressure, body weight and body fat in overweight and obese adults.
Scientific title
A randomised, double-blind, placebo controlled trial of the effect of functional beverages on blood pressure, body weight and body fat in overweight and obese adults.
Secondary ID [1] 1468 0
Nil
Universal Trial Number (UTN)
U1111-1114-3414
Trial acronym
QUENCH Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood pressure (including hypertension) 256924 0
Overweight and Obesity 256925 0
Inflammation 256926 0
Hypercholesterolaemia 256927 0
Condition category
Condition code
Diet and Nutrition 257069 257069 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Green Tea, Coffee and purple carrot drink - all with a similar combination of grape, olive leave and seaweed extracts. There is also a green tea with mango seed extract. Participants will be allocated to one intervention beverage which is to be consumed orally, three serves per day for 16 weeks). The products will be presented as dry serves for instant rehydration with near-boiling water. The dry weights of the beverage serves are: green tea 0.6g, coffee 2.4g, purple carrot drink 4g and green tea with mango extract 4g.
Intervention code [1] 256117 0
Treatment: Other
Comparator / control treatment
Placebo black tea, coffee, fruit/vegetable based drinks (with flavours/colours added where applicable)
Control group
Placebo

Outcomes
Primary outcome [1] 257964 0
Blood pressure.
Assessed using digital sphygmomanometers.
Timepoint [1] 257964 0
At baseline, 2,4,6,8 weeks, 4, 6 and 12 months
Primary outcome [2] 257965 0
Body weight and body composition (including waist circumference).
Assessed using digital weighing scales, air displacement plethysmography (BodPod), and measuring tape.
Timepoint [2] 257965 0
At baseline, 2,4,6,8 weeks, 4, 6 and 12 months
Primary outcome [3] 257966 0
Total and Low-Density Lipoprotein (LDL) cholesterol.
Assessed using blood test.
Timepoint [3] 257966 0
At baseline, 4,8 weeks, 4, 6 and 12 months
Primary outcome [4] 257967 0
Inflammation (hsC-reactive protein).
Assessed using blood test.
Timepoint [4] 257967 0
At baseline, 4,8 weeks, 4, 6 and 12 months
Secondary outcome [1] 263498 0
Digestion of fat (lipase enzyme activity).
Assessed using blood test.
Timepoint [1] 263498 0
At baseline, 4, 8 weeks, 4, 6 and 12 months
Secondary outcome [2] 263499 0
Electrolytes/Liver Function Tests (E/LFTs).
Assessed using blood test.
Timepoint [2] 263499 0
At baseline, 4,8 weeks, 4, 6 and 12 months
Secondary outcome [3] 263500 0
Adiponectin, Vitamin D and Free Fatty Acids.
Assessed using blood test.
Timepoint [3] 263500 0
At baseline and 4 months

Eligibility
Key inclusion criteria
Body Mass Index of 25-35kg/m^2
Stable blood pressure in the "normal" (=110/70mmHg),“high-normal” (120-139/80-90mmHg) or “mildly hypertensive” (140-159/90-99mmHg) and must be on medication if the blood pressure is 140/90 159/99 mmHg.
Must be otherwise healthy.
Participants must be capable of giving informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Must not be pregnant or breastfeeding
Participants already consuming functional beverage products (except if participants conduct four week wash-out period).
Participants will be required to withdraw from the trial and seek further medical advice if there is substantial elevation in blood pressure (ie >159/99) at any time, or any sudden drop in blood pressure (<100/60).

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)
Potential participants will undergo telephone screening and attend and information/recruitment session. If participants meet all inclusion/exclusion criteria (as determined by Research Team), and sign informed consent, they will be included in the study. Treatment identification is concealed from participants and the Research Team via numbered treatment containers. The identification of the numbered treatment containers will be held off-site in secure location by a Research Partner. Participants will receive a numbered treatment container at random by the Research Team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment products will be randomised using a simple randomisation table created by computer software (computerised sequence generation). This will result in treatment products being allocated a randomised number. Treatment identification will be concealed from the Research Team and participants. The Research Team will receive treatment products in concealed numbered treatment containers. Participants will receive a treatment product via random selection of a treatment container. The batch number of the treatment container will be recorded by the Research Team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
272
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256613 0
University
Name [1] 256613 0
University of Queensland
Country [1] 256613 0
Australia
Funding source category [2] 256614 0
Commercial sector/Industry
Name [2] 256614 0
Dr Red Nutraceuticals
Country [2] 256614 0
Australia
Primary sponsor type
Individual
Name
Dr Olivia Wright
Address
School of Human Movement Studies
University of Queensland
St Lucia Campus
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 255904 0
None
Name [1] 255904 0
Address [1] 255904 0
Country [1] 255904 0
Other collaborator category [1] 1148 0
Individual
Name [1] 1148 0
Professor Sandra Capra
Address [1] 1148 0
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country [1] 1148 0
Australia
Other collaborator category [2] 1149 0
Individual
Name [2] 1149 0
Associate Professor Judy Bauer
Address [2] 1149 0
The Wesley Hospital / Wesley Research Institute
PO Box 499
Toowong QLD 4066
Country [2] 1149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258643 0
Medical Research Ethics Committee of the University of Queensland
Ethics committee address [1] 258643 0
Ethics committee country [1] 258643 0
Australia
Date submitted for ethics approval [1] 258643 0
Approval date [1] 258643 0
Ethics approval number [1] 258643 0
2010000102
Ethics committee name [2] 258644 0
Uniting Care Human Research Ethics Committee
Ethics committee address [2] 258644 0
Ethics committee country [2] 258644 0
Australia
Date submitted for ethics approval [2] 258644 0
Approval date [2] 258644 0
23/12/2009
Ethics approval number [2] 258644 0
0955

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

Contacts
Principal investigator
Name 30907 0
Address 30907 0
Country 30907 0
Phone 30907 0
Fax 30907 0
Email 30907 0
Contact person for public queries
Name 14154 0
Dr Olivia Wright
Address 14154 0
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country 14154 0
Australia
Phone 14154 0
+61 7 33467768
Fax 14154 0
Email 14154 0
[email protected]
Contact person for scientific queries
Name 5082 0
Dr Olivia Wright
Address 5082 0
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country 5082 0
Australia
Phone 5082 0
+61 7 33467768
Fax 5082 0
Email 5082 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
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