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Trial registered on ANZCTR


Registration number
ACTRN12617000042347
Ethics application status
Approved
Date submitted
31/10/2016
Date registered
10/01/2017
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Clinical Study To Investigate The Safety and Efficacy of W8biotic as a Weight Loss (meal replacement) Intervention in Overweight and Obese Adult Volunteers.
Scientific title
A Clinical Study To Investigate The Safety and Efficacy of W8biotic as a Weight Loss (meal replacement) Intervention in Overweight and Obese Adult Volunteers.
Secondary ID [1] 290417 0
None
Secondary ID [2] 290418 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 300757 0
Obese 300758 0
Condition category
Condition code
Diet and Nutrition 300595 300595 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study aims to confirm the safety and efficacy of substituting the midday meal with a meal replacement shake (W8Biotic) in clinically overweight and obese adult volunteers for a period of 8 weeks. Participants will self-administer 1 scoop (25g) of W8Biotic in 250mL of water at midday each day for 56 days. Meals consumed morning and night will be participants choice, and will be precisely recorded via a food diary. Clinical Trial coordinator will deliver intervention to qualifying participants. Participants will be monitored by a daily consumption diary and the return of empty tub.
W8Biotic ingredients: 25 g (1 scoop) dose = 200.8Kj
Hi-Maize Resistant Starch 20 g
L-leucine 2 g
Levocarnitine Tartrate 1.5 g
Equiv. Levocarnitine 1 g
Lactobacillus plantarum 10 Billion CFU
Lactobacillus paracasei 10 Billion CFU
Intervention code [1] 296253 0
Treatment: Other
Comparator / control treatment
Allocation: non-randomized
Treatment Endpoint: BMI and DEXA scores
Intervention Model: oral administration
Masking: non-blinded
Primary Purpose: safety and efficacy
No control group
Control group
Active

Outcomes
Primary outcome [1] 300012 0
Composite outcome: BMI 28-35 kg/m2/ Waist to Hip Ratio / Blood Pressure.
Timepoint [1] 300012 0
Measured at baseline (T0), Week 4, Week 8. Scales, tape measure and sphygmomanometer will be used.
Primary outcome [2] 300013 0
DEXA scan (Dual-energy X-ray absorptiometry).
Timepoint [2] 300013 0
Measured at baseline (T0), Week 4 and Week 8.
Primary outcome [3] 300014 0
Composite outcome: Blood pathology (Laverty): FBC, Urea/ELFTS, Blood lipids.
Timepoint [3] 300014 0
Blood draws at Baseline (T0), Week 4 and Week 8 via Laverty Pathology.
Secondary outcome [1] 328805 0
SF12 quality of life general health questionnaire
Timepoint [1] 328805 0
SF12 General Health Questionnaire given at Baseline (T0) and Week 8 of trial.

Eligibility
Key inclusion criteria
1) Participants > 18 years of age at time of entry on study
2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
3) Participants agree to undergo venepuncture on multiple occasions
4) Participants agree to adhere to the study protocol
5) BMI range of 28-35 kg/m2
6) Caucasian Ethnicity
7) No history of any chronic diseases
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs
2) Active substance abuse (alcohol or drug dependency)
3) Participants who have less than three meals / day
4) The use of any illicit drugs
5) Pregnant or nursing an infant
6) The current use of any dietary and/or herbal supplements

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
31/01/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294823 0
Commercial sector/Industry
Name [1] 294823 0
Medlab Clinical
Country [1] 294823 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, NSW, 2015
Country
Australia
Secondary sponsor category [1] 293668 0
None
Name [1] 293668 0
Address [1] 293668 0
Country [1] 293668 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296214 0
National Institute of Integrative Medicine
Ethics committee address [1] 296214 0
Ethics committee country [1] 296214 0
Australia
Date submitted for ethics approval [1] 296214 0
Approval date [1] 296214 0
09/09/2016
Ethics approval number [1] 296214 0
0035E_2016

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

Contacts
Principal investigator
Name 70014 0
Prof Luis Vitetta
Address 70014 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 70014 0
Australia
Phone 70014 0
+610281880311
Fax 70014 0
Email 70014 0
luis_vitetta@medlab.co
Contact person for public queries
Name 70015 0
Tessa Nikov
Address 70015 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 70015 0
Australia
Phone 70015 0
+610281880311
Fax 70015 0
Email 70015 0
tessa_nikov@medlab.co
Contact person for scientific queries
Name 70016 0
Luis Vitetta
Address 70016 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015.
Country 70016 0
Australia
Phone 70016 0
+610281880311
Fax 70016 0
Email 70016 0
luis_vitetta@medlab.co

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.