Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000272796
Ethics application status
Approved
Date submitted
5/03/2013
Date registered
6/03/2013
Date last updated
6/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Caralluma fimbriata extract (Slimaluma) combined with Morosil extract reduce the risk factors of metabolic syndrome in overweight and obese adults?
Scientific title
The effect of Caralluma fimbriata extract combined with Morosil extract on the risk factors of metabolic syndrome in overweight and obese adults: a randomised controlled clinical trial
Secondary ID [1] 282073 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 288563 0
Condition category
Condition code
Alternative and Complementary Medicine 288893 288893 0 0
Herbal remedies
Diet and Nutrition 288894 288894 0 0
Obesity
Metabolic and Endocrine 288895 288895 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Placebo group + nutrition advice: Participants will take one 500mg capsule (containing maltodextrin/Placebo) and one 250mg capsule (containing maltodextrin/placebo) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults.

Group 2: Caralluma fimbriata + nutrition advice group: Participants will take one 500mg capsule (containing Caralluma fimbriata extract) and one 250mg capsule (containing maltodextrin/placebo) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults.

Group 3: Morosil + nutrition advice group: Participants will take one 500mg capsule (containing Maltodextrin/ Placebo) and one 250mg capsule (containing Morosil extract) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults.

Group 4: Caralluma fimbriata + Morosil + nutrition advice: Participants will take one 500mg capsule (containing Caralluma fimbriata extract) and one 250mg capsule (containing Morosil) orally 30 minutes before meals twice daily for 16 weeks. Participants will also receive nutrition advice in a one on one nutrition consultation with a nutritional therapist for 30-45 minutes, fortnightly for 16 weeks. The recommendations will be based on the Australian Dietary Guidelines for Adults.
Intervention code [1] 286670 0
Prevention
Intervention code [2] 286671 0
Lifestyle
Comparator / control treatment
The placebo capsules will contain 100% maltodextrin. The placebo capsules will be opaque and indistinguishable in appearance, size, texture and smell from the capsules with the active ingredient. The taste of the capsules will be identical as the capsules with the active ingredient provided that they are swallowed whole as instructed.
Control group
Placebo

Outcomes
Primary outcome [1] 289021 0
Anthropometric measurements including body weight, height, body mass index, waist circumference, hip circumference, waist to hip ratio, percentage body fat, bone mineral mass, lean body mass and girth/ circumference measurments.
Timepoint [1] 289021 0
Anthropometric measurements including body weight, height, body mass index, waist circumference, hip circumference & waist to hip ratio will be conducted pre and post intervention and fortnightly during the intervention.
Percentage body fat, bone mineral mass, lean body mass and girth/ circumference measurments will be conducted pre and post intervention.
Primary outcome [2] 289022 0
Blood sample analysis of obesity markers including adipocytokines and lipid profile
Timepoint [2] 289022 0
Pre and post intervention
Primary outcome [3] 289024 0
Appetite test via the visual analogue scales (VAS) method and food intake assessment via 3 day food diaries & food freqency questionnaire.
Timepoint [3] 289024 0
Pre and post intervention for appetite test and food frequency questionnaire. Fortnightly collection of food diaries during the 16 week period.
Secondary outcome [1] 301590 0
Basal metabolic rate (BMR) will be measured using the metabolic cart (closed circuit spirometry)
Timepoint [1] 301590 0
Pre and post intervention
Secondary outcome [2] 301591 0
Physcial activity assessment via physcial activity questionnaire, physical activity diary, accelerometer.
Timepoint [2] 301591 0
Pre and post intervention
Secondary outcome [3] 301592 0
Blood pressure and heart rate will be measured in a seated position using an automated digital BP monitor
Timepoint [3] 301592 0
Fortnightly during the 16 week intervention period
Secondary outcome [4] 301593 0
Continuous glucose monitoring
Timepoint [4] 301593 0
Pre and post intervention

Eligibility
Key inclusion criteria
Inclusion criteria: Overweight or obese (BMI >25), waist circumference of > 94 cm (male), >80 cm (female), Age: 20-60 years, male or female.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Cigarette smoker, hypertension, all types of heart, Liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286848 0
University
Name [1] 286848 0
Victoria University
Country [1] 286848 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
McKechnie Street
St Albans,
PO BOX 14428
Melbourne, Victoria 8001
Country
Australia
Secondary sponsor category [1] 285640 0
None
Name [1] 285640 0
Address [1] 285640 0
Country [1] 285640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288914 0
Victoira University Human Research Ethics Committee
Ethics committee address [1] 288914 0
Ethics committee country [1] 288914 0
Australia
Date submitted for ethics approval [1] 288914 0
02/10/2012
Approval date [1] 288914 0
11/02/2013
Ethics approval number [1] 288914 0
HRETH 12/264

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

Contacts
Principal investigator
Name 38310 0
Dr Xiao Su
Address 38310 0
College of Health & Biomedicine, Victoria University, McKechnie Street, St Albans, PO Box 14428, Melbourne, VIC 8001
Country 38310 0
Australia
Phone 38310 0
+61 3 9919 2318
Fax 38310 0
Email 38310 0
[email protected]
Contact person for public queries
Name 38311 0
Katie Astell
Address 38311 0
College of Health & Biomedicine, Victoria University, McKechnie Street, St Albans, PO Box 14428, Melbourne, VIC 8001
Country 38311 0
Australia
Phone 38311 0
+61 413 974 652
Fax 38311 0
Email 38311 0
[email protected]
Contact person for scientific queries
Name 38312 0
Katie Astell, Xiao Su, Michael Mathai
Address 38312 0
College of Health & Biomedicine, Victoria University, McKechnie Street, St Albans, PO Box 14428, Melbourne, VIC 8001
Country 38312 0
Australia
Phone 38312 0
+61 3 9919 2318; +61 3 9919 2211
Fax 38312 0
Email 38312 0
[email protected] or [email protected] or [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
No additional documents have been identified.