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Trial registered on ANZCTR


Registration number
ACTRN12618001215213
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
19/07/2018
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Morosil® on weight loss in overweight but otherwise healthy men and women. A randomised double-blind placebo-controlled study.
Scientific title
Efficacy of Morosil® on weight loss in overweight but otherwise healthy men and women. A randomised double-blind placebo-controlled study.
Secondary ID [1] 295411 0
Nil
Universal Trial Number (UTN)
Trial acronym
BIO-MOR18
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 308642 0
Condition category
Condition code
Diet and Nutrition 307586 307586 0 0
Obesity
Alternative and Complementary Medicine 307587 307587 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational product is a standardized extract obtained from the juice of Moro red oranges (Citrus sinensis). Citrus sinensis is a TGA approved therapeutic ingredient in complementary medicines.

The trial product will be in capsule form, containing 400mg of Morosil extract to be taken twice per day with 200mL water at breakfast and dinner for 6 months.

All participants will receive the same standard advice regarding physical activity. Specifically, participants will be asked to undertake 30 minutes of walking 3 times per week and record all physical activity in their diaries.

In terms of dietary advice, participants will be asked to follow a kilojoule controlled diet. The amount of kilojoules to be consumed daily by each participant will be calculated using the basal metabolic rate score from their DEXA scan.

Adherence will be monitored by trial product container return at the end of the study allowing for capsule count.
Intervention code [1] 301716 0
Treatment: Drugs
Comparator / control treatment
The placebo product will be maltodextrin and will appear identical to the investigational product. One capsule of the placebo is to be taken at breakfast with 200mL water and one capsule at dinner time with 200mL water.

Adherence will be monitored by trial product container return at the end of the study allowing for capsule count.
Control group
Placebo

Outcomes
Primary outcome [1] 306563 0
body weight measured via scales
Timepoint [1] 306563 0
Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [1] 348889 0
Dietary energy intake via 24 hour food recall
Timepoint [1] 348889 0
Baseline, month 2, 4 and 6 post commencement of intervention
Secondary outcome [2] 348891 0
physical activity type via completing an online physical activity diary
Timepoint [2] 348891 0
Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [3] 348892 0
fasting glucose measured via blood test
Timepoint [3] 348892 0
Baseline, month 3 and 6 post commencement of intervention
Secondary outcome [4] 348893 0
fasting lipid profile via blood test
Timepoint [4] 348893 0
Baseline months 3 and 6 post commencement of intervention
Secondary outcome [5] 348894 0
Fasting adiponectin measured via blood test
Timepoint [5] 348894 0
Baseline, months 3 and 6 post commencement of intervention
Secondary outcome [6] 348895 0
Fasting grehelin measured by blood test
Timepoint [6] 348895 0
Baseline, months 3 and 6 post commencement of intervention
Secondary outcome [7] 348896 0
Safety markers E/LFT measured by blood test
Timepoint [7] 348896 0
Baseline, months 3 and 6 post commencement of intervention
Secondary outcome [8] 348897 0
Gastrointestinal tolerance measured by GIT questionnaire
Timepoint [8] 348897 0
Baseline, months 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [9] 348898 0
fatigue severity as measured by VAS-F
Timepoint [9] 348898 0
baseline, months 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [10] 349598 0
fasting insulin measured via blood test
Timepoint [10] 349598 0
Baseline, month 3 and 6 post commencement of intervention
Secondary outcome [11] 349605 0
hip circumference measured via tape measure
Timepoint [11] 349605 0
Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [12] 349606 0
waist circumference measured via tape measure
Timepoint [12] 349606 0
Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [13] 349607 0
thigh circumference measured via tape measure
Timepoint [13] 349607 0
Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of
Secondary outcome [14] 349608 0
fasting leptin measured via blood test
Timepoint [14] 349608 0
Baseline, months 3 and 6 post commencement of intervention
Secondary outcome [15] 349609 0
lean muscle mass measured via DEXA scan
Timepoint [15] 349609 0
baseline, month 3 and 6 post commencement of intervention
Secondary outcome [16] 349610 0
total abdominal fat measured by DEXA scan
Timepoint [16] 349610 0
baseline, month 3 and 6 post commencement of intervention
Secondary outcome [17] 349611 0
level of visceral fat measured by DEXA scan
Timepoint [17] 349611 0
baseline, month 3 and 6 post commencement of intervention
Secondary outcome [18] 349612 0
level of subcutaneous fat measured by DEXA scan
Timepoint [18] 349612 0
baseline, month 3 and 6 post commencement of intervention
Secondary outcome [19] 349613 0
android fat levels measured via DEXA scan
Timepoint [19] 349613 0
baseline, month 3 and 6 post commencement of intervention
Secondary outcome [20] 349614 0
Body mass index measured by DEXA scan
Timepoint [20] 349614 0
baseline, month 3 and 6 post commencement of intervention
Secondary outcome [21] 349673 0
Physical activity frequency via completing an online physical activity diary
Timepoint [21] 349673 0
Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention
Secondary outcome [22] 349674 0
Gynoid fat levels measured via DEXA scan
Timepoint [22] 349674 0
baseline, month 3 and 6 post commencement of intervention

Eligibility
Key inclusion criteria
Males and females aged between 20 and 65 years
BMI >25 - <40 kg/m2
Not currently taking any medication, supplements or functional foods targeted at weight loss and/ appetite control
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
Minimum age
20 Years
Maximum age
65 Years
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
Significant variation in weight (more than 10%) in the past 3 months
Participation in another weight loss clinical trial in the past 3 months
No 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
Elite or training Athletes
Smokers
Shift workers/unusual sleep and/or dietary patterns
Excessive caffeine intake (>4 caffeinated drinks daily)
Allergic to any of the ingredients in active or placebo formula
No current use of weight loss supplements or 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)
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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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] 299998 0
Commercial sector/Industry
Name [1] 299998 0
BIONAP S.r.l
Address [1] 299998 0
Contrada Fureria Zona Industriale Ovest
95032 Piano Tavola Belpasso Italy
Country [1] 299998 0
Italy
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street, Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 299382 0
None
Name [1] 299382 0
Address [1] 299382 0
Country [1] 299382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300853 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 300853 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300853 0
Australia
Date submitted for ethics approval [1] 300853 0
21/08/2018
Approval date [1] 300853 0
25/10/2018
Ethics approval number [1] 300853 0

Summary
Brief summary
This is a single-site, double-blind, randomised, clinical trial for 6 months treatment duration and utilising active and placebo arms with baseline data collection.

150 overweight male and female participants aged between 20 and 65 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=75) or the active intervention group (n=75 per group). Dietary intake and body measurements (weight, height, hip circumference, waist circumference, blood pressure and heart rate) will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Participants will also be required to have a DXA scan.

All participants will receive the same standard advice regarding physical activity. Specifically, participants will be asked to undertake 30 minutes of walking 3 times per week and record all physical activity in their diaries.

In terms of dietary advice, participants will be asked to follow a kilojoule controlled diet. The amount of kilojoules to be consumed daily by each participant will be calculated using the basal metabolic rate score from their DEXA scan. Participants will be asked to record their daily food intake in a kilojoule counter app and submit a 24hr food recall every two months during the study. Guidance in the form of example meal plans will be provided.

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 months 1, 2, 3, 4 and 5 for a body measures, dietary intake and tolerance assessment.

At the completion of the study (month 6), an assessment identical to that undertaken at baseline will be carried out.

Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to during each scheduled site visit.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85038 0
Dr David Briskey
Address 85038 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85038 0
Australia
Phone 85038 0
+61 421 784 077
Fax 85038 0
Email 85038 0
d.briskey@uq.edu.au
Contact person for public queries
Name 85039 0
Ms Amanda Rao
Address 85039 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85039 0
Australia
Phone 85039 0
+61 414 488 559
Fax 85039 0
Email 85039 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 85040 0
Ms Amanda Rao
Address 85040 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85040 0
Australia
Phone 85040 0
+61 414 488 559
Fax 85040 0
Email 85040 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
IPD will not be available
What supporting documents are/will be available?
Ethical approval
Attachments/websites
Type [1] 121 0
Ethical approval
URL/details/comments [1] 121 0
Summary results
No Results