ANZCTR - Registration

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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

13/09/2021

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]

Nil

Universal Trial Number (UTN)

Trial acronym

BIO-MOR18

Linked study record

Health condition

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

Overweight

Condition category

Condition code

Diet and Nutrition

Obesity

Alternative and Complementary Medicine

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 400 mg of Morosil extract to be taken once per day with 200 mL water at breakfast.

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]

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 once per day with 200ml of water at breakfast.
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]

body weight measured via scales

Timepoint [1]

Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [1]

Dietary energy intake via 24 hour food recall

Timepoint [1]

Baseline, month 2, 4 and 6 post commencement of intervention

Secondary outcome [2]

physical activity type via completing an online physical activity diary

Timepoint [2]

Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [3]

fasting glucose measured via blood test

Timepoint [3]

Baseline, month 3 and 6 post commencement of intervention

Secondary outcome [4]

fasting lipid profile via blood test

Timepoint [4]

Baseline months 3 and 6 post commencement of intervention

Secondary outcome [5]

Fasting adiponectin measured via blood test

Timepoint [5]

Baseline, months 3 and 6 post commencement of intervention

Secondary outcome [6]

Fasting grehelin measured by blood test

Timepoint [6]

Baseline, months 3 and 6 post commencement of intervention

Secondary outcome [7]

Safety markers E/LFT measured by blood test

Timepoint [7]

Baseline, months 3 and 6 post commencement of intervention

Secondary outcome [8]

Gastrointestinal tolerance measured by GIT questionnaire

Timepoint [8]

Baseline, months 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [9]

fatigue severity as measured by VAS-F

Timepoint [9]

baseline, months 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [10]

fasting insulin measured via blood test

Timepoint [10]

Baseline, month 3 and 6 post commencement of intervention

Secondary outcome [11]

hip circumference measured via tape measure

Timepoint [11]

Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [12]

waist circumference measured via tape measure

Timepoint [12]

Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [13]

thigh circumference measured via tape measure

Timepoint [13]

Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of

Secondary outcome [14]

fasting leptin measured via blood test

Timepoint [14]

Baseline, months 3 and 6 post commencement of intervention

Secondary outcome [15]

lean muscle mass measured via DEXA scan

Timepoint [15]

baseline, month 3 and 6 post commencement of intervention

Secondary outcome [16]

total abdominal fat measured by DEXA scan

Timepoint [16]

baseline, month 3 and 6 post commencement of intervention

Secondary outcome [17]

level of visceral fat measured by DEXA scan

Timepoint [17]

baseline, month 3 and 6 post commencement of intervention

Secondary outcome [18]

level of subcutaneous fat measured by DEXA scan

Timepoint [18]

baseline, month 3 and 6 post commencement of intervention

Secondary outcome [19]

android fat levels measured via DEXA scan

Timepoint [19]

baseline, month 3 and 6 post commencement of intervention

Secondary outcome [20]

Body mass index measured by DEXA scan

Timepoint [20]

baseline, month 3 and 6 post commencement of intervention

Secondary outcome [21]

Physical activity frequency via completing an online physical activity diary

Timepoint [21]

Baseline, month 1, 2, 3, 4, 5 and 6 post commencement of intervention

Secondary outcome [22]

Gynoid fat levels measured via DEXA scan

Timepoint [22]

baseline, month 3 and 6 post commencement of intervention

Eligibility

Key inclusion criteria

Males and females aged between 20 and 65 years
BMI >25 - <35 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

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
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

Data will be analysed as a whole set with BMI >25 - <35 as well as additional sub-group analysis of participants with BMI >25 - <30.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

19/11/2018

Actual

14/11/2018

Date of last participant enrolment

Anticipated

Actual

4/12/2019

Date of last data collection

Anticipated

31/07/2020

Actual

6/06/2020

Sample size

Target

150

Accrual to date

Final

180

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

BIONAP S.r.l

Address [1]

Contrada Fureria Zona Industriale Ovest
95032 Piano Tavola Belpasso Italy

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

129 Glen Osmond Road Eastwood South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/08/2018

Approval date [1]

25/10/2018

Ethics approval number [1]

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

Dr David Briskey

Address

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

Country

Australia

Phone

+61 421 784 077

Fax

d.briskey@uq.edu.au

Contact person for public queries

Name

Amanda Rao

Address

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

Country

Australia

Phone

+61 414 488 559

Fax

amanda@rdcglobal.com.au

Contact person for scientific queries

Name

Amanda Rao

Address

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

Country

Australia

Phone

+61 414 488 559

Fax

amanda@rdcglobal.com.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

IPD will not be available

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
121	Ethical approval					375495-(Uploaded-06-11-2018-11-44-08)-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

Source	Title	Year of Publication	DOI
Embase	Effectiveness of "Moro" Blood Orange Citrus sinensis Osbeck (Rutaceae) Standardized Extract on Weight Loss in Overweight but Otherwise Healthy Men and Women-A Randomized Double-Blind Placebo-Controlled Study.	2022	https://dx.doi.org/10.3390/nu14030427

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically