Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000872336
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
15/06/2017
Date last updated
1/07/2021
Date data sharing statement initially provided
4/04/2019
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, Slimaluma capsules on appetite control and body composition in overweight men and women aged between 20 and 50 years.
Scientific title
A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Slimaluma capsules on appetite control and body composition in overweight men and women aged between 20 and 50 years.
Secondary ID [1] 291242 0
SLM-SAT17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 302170 0
appetite control 302172 0
Condition category
Condition code
Diet and Nutrition 301780 301780 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the effect of Slimaluma on body appetite control and body composition in healthy males and females to better understand its effectiveness.

The investigational product is a commercially available capsule-form herbal medicine containing C. Fimbriata extract. The daily dose will be 1g across 2 capsules, 1 taken before breakfast and one before dinner for a period of 16 weeks.

Approximately 120 overweight male and female participants aged between 20 and 50 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 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=60) or the active intervention group (n=60 per group). Satiety, dietary intake, body composition and tolerance will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. All participants will receive the same standard advice regarding diet and physical activity.

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 4, 8, 12 and 16 for a body composition, satiety, dietary intake and tolerance assessment.

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

Compliance will be monitored by capsule count upon return of trial product container at the end of the study.

Everyone will be told to continue with their normal level of physical activity and to not change the diet if possible. If they do increase or decrease physical activity then an exercise physiologist will be consulted. And if they do change their diet then a dietitian will be consulted. Any changes will be self-monitored and self-reported. And any changes will be reported to RDC GLOBAL Pty Ltd but not affect study participation. And any changes will be considered once the study is completed.
Intervention code [1] 297245 0
Treatment: Other
Comparator / control treatment
The placebo group are instructed to take the product twice daily as per the same instructions as the active arm. The placebo is a maltodextrin vegetarian capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 301176 0
Appetite Control measured by plasma ghrelin
Timepoint [1] 301176 0
Baseline and week 16 only
Primary outcome [2] 302411 0
Appetite Control Measured by plasma leptin
Timepoint [2] 302411 0
Baseline and week 16 only
Secondary outcome [1] 331965 0
Body Composition measured by DEXA
Timepoint [1] 331965 0
Baseline
Week 16
Secondary outcome [2] 331966 0
safety: liver AST, ALT, GGT, Bilirubin plasma
Timepoint [2] 331966 0
Baseline and week 16 only
Secondary outcome [3] 331967 0
Tolerance
GIO (gastrointestinal symptom questionnaire) - questionnaire used in previous studies
Timepoint [3] 331967 0
Baseline, weeks 4, 8, 12 and 16
Secondary outcome [4] 335501 0
Hip and waist ratio
Timepoint [4] 335501 0
Baseline, weeks 4, 8, 12 and 16
Secondary outcome [5] 335502 0
plasma glucose
Timepoint [5] 335502 0
Baseline and week 16 only
Secondary outcome [6] 335503 0
Subjective appetite and satiety - Motivation to Eat Questionnaire
Timepoint [6] 335503 0
Baseline, weeks 4, 8, 12 and 16
Secondary outcome [7] 335504 0
Energy intake - 24 hour food diary
Timepoint [7] 335504 0
Baseline, weeks 4, 8, 12 and 16
Secondary outcome [8] 335505 0
Energy (VAS-F visual analogues scale to evaluate fatigue severity)
Timepoint [8] 335505 0
Baseline, weeks 4, 8, 12 and 16
Secondary outcome [9] 335895 0
Appetite control measured by plasma IGF-1
Timepoint [9] 335895 0
Baseline and week 16 only
Secondary outcome [10] 335896 0
Appetite control measured by plasma serotonin
Timepoint [10] 335896 0
Baseline and week 16 only
Secondary outcome [11] 335900 0
Appetite control measured by plasma glucocorticoids
Timepoint [11] 335900 0
Baseline and week 16 only
Secondary outcome [12] 335901 0
Appetite control measured by plasma agouti-related peptide
Timepoint [12] 335901 0
Baseline and week 16 only
Secondary outcome [13] 335902 0
Appetite control measured by CCK Cholecystokinin
Timepoint [13] 335902 0
Baseline and week 16 only
Secondary outcome [14] 335903 0
Plasma insulin
Timepoint [14] 335903 0
Baseline and week 16 only
Secondary outcome [15] 335904 0
Plasma lipid profile
Timepoint [15] 335904 0
Baseline and week 16 only
Secondary outcome [16] 397697 0
Appetite controlled measured by plasma Neuropeptide Y
Timepoint [16] 397697 0
Baseline and week 16

Eligibility
Key inclusion criteria
Males and females aged between 20 and 50 years
Over weight but not clinically obese (BMI >25 - <30 kg/m2)
Not currently taking any supplement or functional foods targeted at appetite control and/or weight loss
Participants who agree to not use other treatment including diets for weight loss and/or appetite control during the study
Participants agreement to participation in the study and investigational schedule
Written informed consent from the participant
Over weight but not clinically obese (BMI >25 - <30 kg/m2) - Changed to (BMI >25 - <34.9 kg/m2)
Females currently using an appropriate form of birth control.
Minimum age
20 Years
Maximum age
50 Years
Sex
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
Significant variation in weight (more than 10%) in the past 3 months
Participation in another clinical trial in the past 3 months
Current use of prescription medications except the oral contraceptive pill if female
Females attempting conception, currently pregnant or breastfeeding
Alcohol consumption of above 2 standards drinks daily, drug use, or other confounding conditions
Malignancy or treatment for malignancy within the previous 2 years
Pregnant or lactating women
Elite or training Athletes
Smokers
Shift workers/unusual sleep and/or dietary patterns
Excessive caffeine intake (>4 caffeinated drinks daily)
Those currently taking fibre supplements of 30-50g daily
Allergic to any of the ingredients in active or placebo formula

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
2/04/2018
Actual
16/04/2018
Date of last participant enrolment
Anticipated
Actual
27/11/2018
Date of last data collection
Anticipated
Actual
18/03/2019
Sample size
Target
120
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295694 0
Commercial sector/Industry
Name [1] 295694 0
Gencor Pacific
Country [1] 295694 0
Hong Kong
Funding source category [2] 295696 0
Commercial sector/Industry
Name [2] 295696 0
Pharmako Biotechnologies Pty Ltd
Country [2] 295696 0
Australia
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] 294536 0
Commercial sector/Industry
Name [1] 294536 0
Pharmako Biotechnologies Pty Ltd
Address [1] 294536 0
Campbell Ave Cromer, NSW, 2099
Country [1] 294536 0
Australia
Secondary sponsor category [2] 295595 0
Commercial sector/Industry
Name [2] 295595 0
Gencor Pacific
Address [2] 295595 0
21-E,Elegance Hillgrove Village, Discovery Bay, Hong Kong
Country [2] 295595 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297002 0
BellBerry Ltd
Ethics committee address [1] 297002 0
Ethics committee country [1] 297002 0
Australia
Date submitted for ethics approval [1] 297002 0
21/12/2016
Approval date [1] 297002 0
30/05/2017
Ethics approval number [1] 297002 0

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

Contacts
Principal investigator
Name 72678 0
Dr David Briskey
Address 72678 0
School of Human Movement and Nutrition Sciences
Faculty of Health and Behavioural Sciences
University of Queensland
St Lucia, QLD 4072
Country 72678 0
Australia
Phone 72678 0
+61 421 784 077
Fax 72678 0
Email 72678 0
[email protected]
Contact person for public queries
Name 72679 0
Amanda Rao
Address 72679 0
RDC GLOBAL Pty Ltd
3B/76 Doggett St
Newstead QLD 4006
Country 72679 0
Australia
Phone 72679 0
+61 414 488 559
Fax 72679 0
Email 72679 0
[email protected]
Contact person for scientific queries
Name 72680 0
Amanda Rao
Address 72680 0
RDC GLOBAL Pty Ltd
3B/76 Doggett St
Newstead QLD 4006
Country 72680 0
Australia
Phone 72680 0
+61 414 488 559
Fax 72680 0
Email 72680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


What supporting documents are/will be available?




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.