Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000470897
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
21/04/2021
Date last updated
21/01/2024
Date data sharing statement initially provided
21/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind placebo-controlled randomised clinical trial assessing the efficacy and safety of a novel herbal formulation for weight loss in an Australian population of healthy adults who are overweight.
Scientific title
A double-blind placebo-controlled randomised clinical trial assessing the efficacy and safety of a novel herbal formulation for weight loss in an Australian population of healthy adults who are overweight.
Secondary ID [1] 303272 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 320466 0
Condition category
Condition code
Alternative and Complementary Medicine 318351 318351 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proprietary combined extracts called Slendacor/Slimvance from PLT health was prepared in the ratio of six parts Moringa oleifera (family Moringaceae) leaf, three parts Murraya koenigii (L.) Spreng. (family Rutaceae), and one-part Curcuma longa L. (family Zingiberaceae) extract standardised to not less than 95% total curcuminoids. The extraction solvent for each includes:
Curcuma longa: 100% ethanol extract and 100% ethyl acetate
Moringa olefere: ethanol:water (90:10)
Murraya keonigi: ethanol:water (60:40)
The excipients include colloidal anhydrous silica, magnesium stearate and silicon dioxide in a gelatine capsule size “0”.

The dosage is 1 capsules (450mg) twice a day 30 minutes before breakfast and dinner.

This is to be taken for 16 weeks.

Compliance will be measured by capsule return and counting at each follow-up. The participants will be asked to bring back all empty containers as well as those with capsules remaining. These will also be checked against the participant diaries.
Intervention code [1] 319576 0
Treatment: Other
Comparator / control treatment
The placebo is manufactured in Australia by a GMP approved facility. It contains colloidal anhydrous silica, magnesium stearate, silicon dioxide in a gelatine capsule size “0’. It is similar in smell, taste and sight to the herbal formulation L185008F.
Control group
Placebo

Outcomes
Primary outcome [1] 326321 0
To evaluate the effects of a novel herbal formulation for weight loss on percentage reduction in body weight from baseline to 16 weeks as assessed by percentage change in body weight as measure by a digital weight scale.
Timepoint [1] 326321 0
Baseline, 4, 8, 12, 16 weeks (Primary endpoint)
Secondary outcome [1] 391053 0
To determine the number of participants achieving a loss of at least 5% of initial body weight after 16 weeks as measure by a digital weight scale.
Timepoint [1] 391053 0
0 weeks, 4 weeks, 8 weeks, 16 weeks
Secondary outcome [2] 391054 0
To evaluate the amount of weight loss from baseline to 16 weeks between groups as assessed by changes in body weight via a digital weight scale.
Timepoint [2] 391054 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcome [3] 391055 0
To evaluate the changes in body mass index from baseline to 16 weeks as assessed via a digital weight scale and stadiometer to assess height.
Timepoint [3] 391055 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcome [4] 391056 0
To assess the safety of the novel herbal formulation via blood pathology testing for liver function
Timepoint [4] 391056 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcome [5] 391057 0
To assess the safety of the novel herbal formulation via the reporting of adverse events via the CTCAE v 5 and participant self reported adverse events via a participant diary.
Timepoint [5] 391057 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcome [6] 391058 0
To evaluate the changes in waist circumferences from baseline to 16 weeks using a measuring tape.
Timepoint [6] 391058 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcome [7] 391059 0
To evaluate lipid profiles via blood pathology tests from baseline to 16 weeks
Timepoint [7] 391059 0
o weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcome [8] 393169 0
To assess the safety of the novel herbal formulation via blood pathology testing for kidney function.
Timepoint [8] 393169 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Secondary outcome [9] 393170 0
To evaluate the changes in waist to hip ratio from baseline to 16 weeks via measuring tape.
Timepoint [9] 393170 0
0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Eligibility
Key inclusion criteria
1. Adults aged between 18 and 60 years old
2. BMI 25-29.9 kg/m2
3. Willingness to consume the prescribed study diet of approximately 1,500 KCal for women and 2000 KCal for men per day
4. Negative pregnancy test at baseline and 3 months for females of childbearing age, use of reliable contraception throughout the trial
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Obesity (BMI equal to or greater than 30)
2. Current use of other weight loss medications including stimulants, laxatives or diuretics taken solely for the purpose of weight loss in the last 3 months.
3. Recent unexplained weight loss or gain
4. History of eating disorders
5. History of thyroid, cardiovascular disease or diabetes
6. History of other clinically significant disorders (HIV, hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis)
7. History of motor weakness or peripheral sensory neuropathy
8. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
9. Diagnosis of alcoholism or recreational drug use
10. Severe mental illness or difficulty in communicating
11. History of allergy to spices and herbal products
12. Pregnant or breastfeeding females

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)
All researchers will be blinded to the randomisation and the allocation. A computer generated randomised group allocation (A or B) will be provided by the computer system, REDCap once the participant has been enrolled. The number is concealed until the research assistant enrols the participant into the data management system. The number will then appear on the participants file. The participants will be allocated to one of two groups and the group allocation will be noted on the computer system data management and the participant hard copy chart.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be a computer generated random number based on stratified block randomisation. Strata will be based on gender, and trial site. Blocks will be of varying sizes ranging from 4 to 8. The numbers will be generated via https://www.randomizer.org/.
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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed via SPSS 25.0. Analyses will be conducted on an intention-to-treat basis with per-protocol subgroup analysis based on diet and exercise patterns. Descriptive statistics will summarise data as either means (absolute, relative or percentage change) with standard deviations or medians with interquartile range as appropriate for the data. The safety data will be summarised via descriptive statistics. The primary outcome ’percentage change in weight loss’ after 16 weeks will be compared between groups using univariate analysis (ANCOVA) or equivalent non-parametric test depending on the distribution of data, and the effects reported as group differences with 95% confidence intervals. The responder rate, i.e. participants with a weight loss of 5% or greater, will be compared using Chi2 tests. Secondary outcomes will be analysed using comparable methods depending on the data type.
The subject population for analysis will be classified as: Protocol-compliant population. This means all participants randomised into the study that received the protocol required study product (administered at least 90% each week) exposure for at least one month.
End of trial analysis plan:
1. Scores of the weight changes in the intervention group: Weight changes in kilograms from baseline to week 16 will be compared using percentages.

2. Scores of the weight changes between participants: Weight changes in kilograms from baseline to week 16 will be compared using number and percentages between the intervention group and the placebo. Paired T tests and longitudal analyses (GEE) between the intervention and placebo groups will also be conducted.

3. Scores of the BMI between participants: BMI changes from baseline to week 16 will be compared using percentages, paired T tests and longitudal analysis (GEE) between the intervention group and the placebo.

4. Scores of waists to hip ratio’s between participants: Waist to help ratio changes from baseline to week 16 will be compared using percentages, paired T tests and longitudal analysis (GEE) between the intervention group and the placebo.

5. Scores of the blood pathology markers: Blood pathology changes will be compared using paired T tests and longitudal analysis (GEE) between the intervention group and placebo.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2021
Actual
2/06/2021
Date of last participant enrolment
Anticipated
27/01/2023
Actual
26/09/2023
Date of last data collection
Anticipated
26/05/2023
Actual
24/12/2023
Sample size
Target
140
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 32833 0
2480 - Lismore
Recruitment postcode(s) [2] 32834 0
2478 - Ballina
Recruitment postcode(s) [3] 32835 0
4217 - Gold Coast
Recruitment postcode(s) [4] 32836 0
4221 - Palm Beach
Recruitment postcode(s) [5] 32837 0
4103 - Annerley
Recruitment postcode(s) [6] 32838 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 307682 0
Commercial sector/Industry
Name [1] 307682 0
PharmaCare Pty Ltd
Country [1] 307682 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Military Road
Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 308384 0
None
Name [1] 308384 0
none
Address [1] 308384 0
none
Country [1] 308384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307718 0
Southern Cross University HREC
Ethics committee address [1] 307718 0
Ethics committee country [1] 307718 0
Australia
Date submitted for ethics approval [1] 307718 0
15/03/2021
Approval date [1] 307718 0
14/04/2021
Ethics approval number [1] 307718 0
2021/033

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

Contacts
Principal investigator
Name 108258 0
Dr Janet Schloss
Address 108258 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
Lismore NSW 2480
Country 108258 0
Australia
Phone 108258 0
+61 436101306
Fax 108258 0
Email 108258 0
[email protected]
Contact person for public queries
Name 108259 0
Janet Schloss
Address 108259 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
Lismore NSW 2480
Country 108259 0
Australia
Phone 108259 0
+61 436101306
Fax 108259 0
Email 108259 0
[email protected]
Contact person for scientific queries
Name 108260 0
Janet Schloss
Address 108260 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
Lismore NSW 2480
Country 108260 0
Australia
Phone 108260 0
+61 436101306
Fax 108260 0
Email 108260 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 individual participant data will be available. Only non-identifiable data with data analysis of groups.


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.