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Trial registered on ANZCTR


Registration number
ACTRN12617000839303
Ethics application status
Approved
Date submitted
30/05/2017
Date registered
7/06/2017
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Date results information initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Gynostemma pentaphyllum extract (ActivAMP) capsules on body composition in overweight men and women aged over 18 years.
Scientific title
A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Gynostemma pentaphyllum extract (ActivAMP) capsules on body composition in overweight men and women aged over 18 years.
Secondary ID [1] 291241 0
AMP-BOD17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 302168 0
Condition category
Condition code
Alternative and Complementary Medicine 301778 301778 0 0
Herbal remedies
Diet and Nutrition 301779 301779 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational product is a commercially available capsule-form herbal medicine containing Gynostemma pentaphyllum extract (ActivAMP). The daily dose will be 450mg across 2 capsules daily, 1 taken at breakfast and one at dinner for a period of 16 weeks. This regime has been selected on the basis of current standard dosing guidelines for the investigational product.



This study will assess the effect of ActivAMP on body composition and muscle recovery in overweight males and females to better understand its effectiveness.

Approximately 55 male and 55 female participants aged over 18 years will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study.

Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=55) or the active intervention group (n=55 per group). Muscle fatigue, recovery, body composition, dietary intake and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Specifically, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, free fatty acids, blood glucose, E/LFT, kidney function/safety, liver function/safety and inflammatory and antioxidant panel.


Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to attend the study site at weeks 5 and 10 for body composition assessment. An investigator will call participants a few times throughout the 16 weeks study to ask some questions about their usual diet.

At the completion of the study (week 16), an assessment identical to what was undertaken at baseline will be carried out.

Participants will be asked to provide a physical activity and diet diary at the start of the study. Participants will then be asked to maintain their normal level of physical activity for the study duration. At the end of the study, participants will repeat the same diet diary. If participants change their normal level of physical activity or diet they will be asked to inform us as soon as practically possible. Changes in diet and/or exercise will be evaluated by and accredited exercise physiologist. Subsequent suitability for ongoing participation in the trial will be evaluated and any changes will be taken into consideration when evaluating any results of the trial. Participants will also be monitored for compliance with the protocol by email communications in addition to during each scheduled site visit. Interim reporting of project status and adverse drug reactions will be provided to the sponsor and HREC as requested.


Intervention code [1] 297244 0
Treatment: Other
Comparator / control treatment
The placebo is taken twice daily - maltodextrin vegetarian capsule
Control group
Placebo

Outcomes
Primary outcome [1] 301175 0
Body fat % (lean muscle mass, total abdominal fat, visceral fat, subcutaneous fat, android vs gynoid fat) - using DEXA Scan
Timepoint [1] 301175 0
Baseline
Week 16
Secondary outcome [1] 331946 0
BMI
Timepoint [1] 331946 0
Baseline
week 5
week 10
week 16
Secondary outcome [2] 331947 0
Peripheral blood mononuclear cell (PBMC) Ficoll-PlaAMPK concentration
Timepoint [2] 331947 0
Baseline
week 16
Secondary outcome [3] 331948 0
Serum analysis of creatine kinase (CK)
Timepoint [3] 331948 0
Baseline
Week 16
Secondary outcome [4] 331949 0
Relative skeletal muscle index using DEXA scan
Timepoint [4] 331949 0
Baseline
Week 16
Secondary outcome [5] 331950 0
Serum analysis of Total cholesterol
Timepoint [5] 331950 0
Baseline
Week 16
Secondary outcome [6] 331952 0
Assess quality of life via SF-36 Quality of Life Questionnaire
Timepoint [6] 331952 0
Baseline
week 5
week 10
week 16
Secondary outcome [7] 331953 0
Assess dietary intake via diet diary and Food Frequency Questionnaire
Timepoint [7] 331953 0
Baseline
week 5
week 10
week 16
Secondary outcome [8] 335470 0
Waist circumference
Timepoint [8] 335470 0
Baseline
Week 5
Week 10
Week 16
Secondary outcome [9] 335471 0
Wait hip ratio
Timepoint [9] 335471 0
Baseline
Week 5
Week 10
Week 16
Secondary outcome [10] 335472 0
Serum analysis of blood glucose
Timepoint [10] 335472 0
Baseline
Week 16
Secondary outcome [11] 335473 0
Serum analysis of liver function for safety
Timepoint [11] 335473 0
Baseline
Week 5
Week 10
Week 16
Secondary outcome [12] 335475 0
Resting metabolic rate using DEXA Scan
Timepoint [12] 335475 0
Baseline
Week 16
Secondary outcome [13] 335476 0
Lean mass balance using DEXA scan
Timepoint [13] 335476 0
Baseline
Week 16
Secondary outcome [14] 335477 0
Bone mineral content via DEXA scan
Timepoint [14] 335477 0
Baseline
Week 16
Secondary outcome [15] 335584 0
serum analysis of lactate dehydrogenase
Timepoint [15] 335584 0
Baseline
Week 5
Week 10
Week 16
Secondary outcome [16] 335585 0
Serum analysis of 3-methylhistadine (3-MH)
Timepoint [16] 335585 0
Baseline
Week 5
Week 10
Week 16
Secondary outcome [17] 335586 0
Lean mass distribution using DEXA scan
Timepoint [17] 335586 0
Baseline
Week 16
Secondary outcome [18] 335587 0
Serum analysis of Triglycerides
Timepoint [18] 335587 0
Baseline
Week 16
Secondary outcome [19] 335588 0
Serum analysis of LDL-Cholesterol
Timepoint [19] 335588 0
Baseline
Week 16
Secondary outcome [20] 335589 0
Serum analysis of HDL-Cholesterol
Timepoint [20] 335589 0
Baseline
Week 16
Secondary outcome [21] 335590 0
Serum analysis of free fatty acids
Timepoint [21] 335590 0
Baseline
Week 16
Secondary outcome [22] 335591 0
Serum analysis of kidney function for safety
Timepoint [22] 335591 0
Baseline
Week 5
Week 10
Week 16
Secondary outcome [23] 335592 0
Serum analysis of IL-8
Timepoint [23] 335592 0
Baseline
Week 16
Secondary outcome [24] 335593 0
Serum analysis of TNF-a
Timepoint [24] 335593 0
Baseline
Week 16
Secondary outcome [25] 335594 0
Serum analysis of IL-10
Timepoint [25] 335594 0
Baseline
Week 16
Secondary outcome [26] 335595 0
Serum analysis of C-reactive Protein
Timepoint [26] 335595 0
Baseline
Week 16
Secondary outcome [27] 335596 0
Serum analysis of isoprostanes
Timepoint [27] 335596 0
Baseline
Week 16
Secondary outcome [28] 335597 0
Serum analysis of GPX
Timepoint [28] 335597 0
Baseline
Week 16

Eligibility
Key inclusion criteria
Males and females over 18 years of age
Overweight but not clinically obese (BMI >25 - <30 kg/m2)
Not currently taking any supplement or functional foods targeted at weight loss, muscle growth or exercise performance
Participants who agree to not use other treatment including diets for weight loss, muscle growth or exercise performance during the study
Participants agreement to participation in the study and investigation schedule
Written informed consent from the participant
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, gastrointestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled
Females with a clinical diagnosis of Polycystic ovarian syndrome (PCOS)
Prescription medication use other than females on the oral contractive pill
Significant variation in weight (more than 10%) in the past 3 months
Participation in another clinical trial in the past 3 months
Females attempting conception, currently pregnant or breast feeding
Allergies or hypersensitivity of any of the test ingredients
Alcohol consumption above 2 standard drinks daily, drug use, or other confounding conditions

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)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295693 0
Commercial sector/Industry
Name [1] 295693 0
Gencor Pacific
Address [1] 295693 0
21-E,Elegance, Hillgrove Village
Discovery Bay, Hong Kong
Country [1] 295693 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett St, Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 294535 0
Commercial sector/Industry
Name [1] 294535 0
Pharmako Biotechnologies Pty Ltd
Address [1] 294535 0
Campbell Ave Cromer, NSW 2099
Country [1] 294535 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297001 0
BellBerry Ltd
Ethics committee address [1] 297001 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 297001 0
Australia
Date submitted for ethics approval [1] 297001 0
21/12/2016
Approval date [1] 297001 0
23/05/2017
Ethics approval number [1] 297001 0

Summary
Brief summary
A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Gynostemma pentaphyllum extract (ActivAMP) capsules on body composition in overweight men and women aged over 18 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72674 0
Dr David Briskey
Address 72674 0
School of Human Movement and Nutrition Sciences
University of Queensland
St Lucia QLD 4027
Country 72674 0
Australia
Phone 72674 0
+61 421 784 077
Fax 72674 0
Email 72674 0
d.briskey@uq.edu.au
Contact person for public queries
Name 72675 0
Ms Amanda Rao
Address 72675 0
RDC Global Pty Ltd
Amanda Rao
3B/76 Doggett Street
Newstead QLD 4006
Country 72675 0
Australia
Phone 72675 0
+61 414 488 559
Fax 72675 0
Email 72675 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 72676 0
Ms Amanda Rao
Address 72676 0
RDC Global Pty Ltd
Amanda Rao
3B/76 Doggett Street
Newstead QLD 4006

Country 72676 0
Australia
Phone 72676 0
+61 414 488 559
Fax 72676 0
Email 72676 0
amanda@rdcglobal.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IP will be shared
What supporting documents are/will be available?
Ethical approval
Attachments/websites
Type [1] 144 0
Ethical approval
URL/details/comments [1] 144 0
Type [2] 145 0
Ethical approval
URL/details/comments [2] 145 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary