ANZCTR - Registration

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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

19/02/2021

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

Secondary ID [1]

AMP-BOD17

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight/obesity

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Diet and Nutrition

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]

Treatment: Other

Comparator / control treatment

The placebo is taken twice daily - maltodextrin vegetarian capsule

Control group

Placebo

Outcomes

Primary outcome [1]

Body fat % (lean muscle mass, total abdominal fat, visceral fat, subcutaneous fat, android vs gynoid fat) - using DEXA Scan

Timepoint [1]

Baseline
Week 16

Secondary outcome [1]

BMI

Timepoint [1]

Baseline
week 5
week 10
week 16

Secondary outcome [2]

Peripheral blood mononuclear cell (PBMC) Ficoll-PlaAMPK concentration

Timepoint [2]

Baseline
week 16

Secondary outcome [3]

Serum analysis of creatine kinase (CK)

Timepoint [3]

Baseline
Week 16

Secondary outcome [4]

Relative skeletal muscle index using DEXA scan

Timepoint [4]

Baseline
Week 16

Secondary outcome [5]

Serum analysis of Total cholesterol

Timepoint [5]

Baseline
Week 16

Secondary outcome [6]

Assess quality of life via SF-36 Quality of Life Questionnaire

Timepoint [6]

Baseline
week 5
week 10
week 16

Secondary outcome [7]

Assess dietary intake via diet diary and Food Frequency Questionnaire

Timepoint [7]

Baseline
week 5
week 10
week 16

Secondary outcome [8]

Waist circumference

Timepoint [8]

Baseline
Week 5
Week 10
Week 16

Secondary outcome [9]

Wait hip ratio

Timepoint [9]

Baseline
Week 5
Week 10
Week 16

Secondary outcome [10]

Serum analysis of blood glucose

Timepoint [10]

Baseline
Week 16

Secondary outcome [11]

Serum analysis of liver function for safety

Timepoint [11]

Baseline
Week 5
Week 10
Week 16

Secondary outcome [12]

Resting metabolic rate using DEXA Scan

Timepoint [12]

Baseline
Week 16

Secondary outcome [13]

Lean mass balance using DEXA scan

Timepoint [13]

Baseline
Week 16

Secondary outcome [14]

Bone mineral content via DEXA scan

Timepoint [14]

Baseline
Week 16

Secondary outcome [15]

serum analysis of lactate dehydrogenase

Timepoint [15]

Baseline
Week 5
Week 10
Week 16

Secondary outcome [16]

Serum analysis of 3-methylhistadine (3-MH)

Timepoint [16]

Baseline
Week 5
Week 10
Week 16

Secondary outcome [17]

Lean mass distribution using DEXA scan

Timepoint [17]

Baseline
Week 16

Secondary outcome [18]

Serum analysis of Triglycerides

Timepoint [18]

Baseline
Week 16

Secondary outcome [19]

Serum analysis of LDL-Cholesterol

Timepoint [19]

Baseline
Week 16

Secondary outcome [20]

Serum analysis of HDL-Cholesterol

Timepoint [20]

Baseline
Week 16

Secondary outcome [21]

Serum analysis of free fatty acids

Timepoint [21]

Baseline
Week 16

Secondary outcome [22]

Serum analysis of kidney function for safety

Timepoint [22]

Baseline
Week 5
Week 10
Week 16

Secondary outcome [23]

Serum analysis of IL-8

Timepoint [23]

Baseline
Week 16

Secondary outcome [24]

Serum analysis of TNF-a

Timepoint [24]

Baseline
Week 16

Secondary outcome [25]

Serum analysis of IL-10

Timepoint [25]

Baseline
Week 16

Secondary outcome [26]

Serum analysis of C-reactive Protein

Timepoint [26]

Baseline
Week 16

Secondary outcome [27]

Serum analysis of isoprostanes

Timepoint [27]

Baseline
Week 16

Secondary outcome [28]

Serum analysis of GPX

Timepoint [28]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2017

Date of last participant enrolment

Anticipated

Actual

1/04/2020

Date of last data collection

Anticipated

14/08/2018

Actual

30/07/2020

Sample size

Target

110

Accrual to date

Final

177

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Gencor Pacific

Address [1]

21-E,Elegance, Hillgrove Village
Discovery Bay, Hong Kong

Country [1]

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]

Commercial sector/Industry

Name [1]

Pharmako Biotechnologies Pty Ltd

Address [1]

Campbell Ave Cromer, NSW 2099

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

BellBerry Ltd

Ethics committee address [1]

129 Glen Osmond Road
Eastwood South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/12/2016

Approval date [1]

23/05/2017

Ethics approval number [1]

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Briskey

Address

School of Human Movement and Nutrition Sciences
University of Queensland
St Lucia QLD 4027

Country

Australia

Phone

+61 421 784 077

Fax

[email protected]

Contact person for public queries

Name

Ms Amanda Rao

Address

RDC Global Pty Ltd
Amanda Rao
3B/76 Doggett Street
Newstead QLD 4006

Country

Australia

Phone

+61 414 488 559

Fax

[email protected]

Contact person for scientific queries

Name

Ms Amanda Rao

Address

RDC Global Pty Ltd
Amanda Rao
3B/76 Doggett Street
Newstead QLD 4006

Country

Australia

Phone

+61 414 488 559

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No IP will be shared

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
144	Ethical approval					372404-(Uploaded-06-11-2018-14-44-50)-Study-related document.pdf
145	Ethical approval					372404-(Uploaded-06-11-2018-14-45-07)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically