None listed
Conditions
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.
Interventions
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 walkin
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.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed