Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001228673
Ethics application status
Approved
Date submitted
3/10/2014
Date registered
24/11/2014
Date last updated
24/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the dietary supplement Satisfax (Registered Trademark) on weight loss in overweight volunteers.
Scientific title
Effect of the dietary supplement Satisfax (Registered Trademark) on weight loss in overweight volunteers.
Secondary ID [1] 285438 0
Nil
Universal Trial Number (UTN)
U1111-1160-5611
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 293198 0
Condition category
Condition code
Diet and Nutrition 293474 293474 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention with Satisfax (Registered Trademark), a proprietary blend of grape and kiwifruit extract, 3 times a day prior to meals at a dose of of 2 capsules (1 gram). The treatment will be administered for 8 weeks via an oral capsule. Adherence to the treatment regime will be monitored by capsule bottle return and self reporting on line.
Intervention code [1] 290371 0
Treatment: Drugs
Comparator / control treatment
No treatment. The participant's weight during the intervention will be compared to their weight immediately prior to the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293293 0
Body weight recorded on calibrated scales.
Timepoint [1] 293293 0
Eight weeks
Primary outcome [2] 293446 0
Acceptability of the treatment assessed by participants completing a 5 point Likert Scale.
Timepoint [2] 293446 0
8 weeks
Primary outcome [3] 293447 0
Compliance with prescribed dose assessed by participants returning their capsule bottles and the remaining capsules counted and recorded.
Timepoint [3] 293447 0
8 weeks
Secondary outcome [1] 310992 0
Nil
Timepoint [1] 310992 0
Nil

Eligibility
Key inclusion criteria
BMI between 25 and 35
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetic, pregnant or breast feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline demographic and clinical information will be summarized using standard descriptive statistics including means, medians, standard deviations, ranges, frequencies and percentages. Changes in outcomes will be analysed using paired t-tests with a two-tailed p-value <0.05 considered statistically significant. The primary analyses will be undertaken on all completing participants but analyses will also explore weight changes in those participants who exit the study early. Clinical trials demonstrating weight loss by a similar mechanism as is hypothesised for the NZ Extracts product have seen significant changes with 20-60 participants over an 8 week period. For this trial it is intended to recruit 100 participants with the aim that a least 60 will complete the trial. A sample size of 60 will enable an effect size for weight change of >0.4 to be detected as statistically significant (two-sided a=0.05) with greater than 80% power.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
13/10/2014
Actual
21/10/2014
Date of last participant enrolment
Anticipated
25/10/2014
Actual
24/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6388 0
New Zealand
State/province [1] 6388 0
Marlborough

Funding & Sponsors
Funding source category [1] 290044 0
Commercial sector/Industry
Name [1] 290044 0
Tuatara Natural Products Ltd
Country [1] 290044 0
New Zealand
Funding source category [2] 290045 0
Government body
Name [2] 290045 0
Callaghan Innovation
Country [2] 290045 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
New Zealand Extracts Ltd
Address
30 Maxwell Rd
Blenheim 7240
Country
New Zealand
Secondary sponsor category [1] 288734 0
None
Name [1] 288734 0
Address [1] 288734 0
Country [1] 288734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291754 0
Health and Disability Ethics Committees
Ethics committee address [1] 291754 0
c/- MEDSAFE
Level 6
Deloitte House
10 Brandon St
Wellington 6011
Ethics committee country [1] 291754 0
New Zealand
Date submitted for ethics approval [1] 291754 0
27/08/2014
Approval date [1] 291754 0
01/10/2014
Ethics approval number [1] 291754 0
14/STH/144

Summary
Brief summary
The primary purpose of this trial is to measure the acceptability of, and compliance with regular consumption of the health supplement Satisfax and its effect on body weight in overweight volunteers over a period of 8 weeks. We hypothesize that the regular consumption of Satisfax will lead to a loss of weight in overweight volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51882 0
Dr Glenn Vile
Address 51882 0
New Zealand Extracts Ltd
PO Box 549
Blenheim 7240
Country 51882 0
New Zealand
Phone 51882 0
+64 21 734 706
Fax 51882 0
Email 51882 0
glenn@nzextracts.com
Contact person for public queries
Name 51883 0
Dr Glenn Vile
Address 51883 0
New Zealand Extracts Ltd
PO Box 549
Blenheim 7240
Country 51883 0
New Zealand
Phone 51883 0
+64 21 734 706
Fax 51883 0
Email 51883 0
glenn@nzextracts.com
Contact person for scientific queries
Name 51884 0
Dr Glenn Vile
Address 51884 0
New Zealand Extracts Ltd
PO Box 549
Blenheim 7240
Country 51884 0
New Zealand
Phone 51884 0
+64 21 734 706
Fax 51884 0
Email 51884 0
glenn@nzextracts.com

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
No additional documents have been identified.