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Trial registered on ANZCTR


Registration number
ACTRN12612000603819
Ethics application status
Approved
Date submitted
4/06/2012
Date registered
5/06/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A 12 month randomised controlled trial to determine biomarkers from the gut microbiota as management tools for overweight and obesity
Scientific title
A 12 month randomised controlled trial to determine biomarkers from the gut microbiota as management tools for overweight and obesity
Secondary ID [1] 280609 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 286621 0
Condition category
Condition code
Diet and Nutrition 286897 286897 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects are randomised to either a standardised high protein, Mediterranean, or low fat (low GI) diet. Subjects will meet the study dietitian for advice on their allocated diet and prescribed the diet for weight loss i.e. based on the Harris Benedict Equation for estimating energy requirements with an energy deficit of 500 calories daily. Each of the diets will be followed daily over a six month period. Subjects will then be followed up for a further six months (up to month 12). Each of the diets will be costed relatively the same so that there is no extra cost for the participant depending on their randomisation group. For those randomised to the high protein diet, strategies for cutting cost will be educated to participants at the baseline and follow up visits. For example, recipes for budget cuts of meat will be provided, as well as focusing their diets on cheaper sources of protein including canned fish, eggs, milk and yoghurt. Home brand alternatives of similar nutritional quality with also be encouraged. This will also be applicable to those in the Mediterranean diet when including fish and olive oil products. The low GI diet will be based on foods endorsed by the glycemic index foundation with the latest GI values for popular foods explained to subjects.
Intervention code [1] 285002 0
Treatment: Other
Intervention code [2] 285005 0
Early detection / Screening
Comparator / control treatment
All three diets are an intervention. There is no control comparison. In this study we aim to identify microbial signals in stool samples that will allow clinicians to predict which diets will give successful weight loss outcomes (thus avoiding the frustration of diet failures) and also to test how to improve and change a person’s microbiota to a healthy composition.
Control group
Active

Outcomes
Primary outcome [1] 287249 0
1. To develop rapid methods based on microbial biomarkers by which clinicians can predict:
(i) Those who will achieve weight loss in any given lifestyle program and;
(ii) Those who will be maintain their weight loss.
Timepoint [1] 287249 0
Baseline, Month 1, Month 3, Month 6, and Month 12.
Subjects will provide stool samples at these clinic visits for molecular biology processing (PCR, flow cytometry and DGGE) and sequencing.
Secondary outcome [1] 297737 0
1. To test the hypothesis that homeostatic control of the microbiota constrains weight loss outcomes in lifestyle programs.
Timepoint [1] 297737 0
Baseline, Month 1, Month 3, Month 6, Month 12.
Subjects will provide stool samples at these clinic visits for molecular biology processing (PCR, flow cytometry and DGGE) and sequencing.
Secondary outcome [2] 297738 0
2. To examine the differences in weight loss between groups.
Timepoint [2] 297738 0
Month 6, Month 12.
Subjects will be weighed at clinic visits.
Secondary outcome [3] 297739 0
3. To investigate changes in a number of indicators of metabolic disease between groups - fasting blood glucose, lipid profile, liver function, and inflammatory markers.
Timepoint [3] 297739 0
Month 6, Month 12.
Fasting bloods will be taken at clinic visits.
Secondary outcome [4] 297740 0
4. To investigate the change in appetite hormones with changes in microbiota.
Timepoint [4] 297740 0
Month 3, Month 6, Month 12.
Fasting bloods will be taken at clinic visits.

Eligibility
Key inclusion criteria
Aged 18 years or older
BMI 25 – 35 kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent diagnosis of diabetes (< 3 months)
Unstable angina or recent onset of cardiovascular disease
Serious hepatic or renal disease
- serum transaminases (ALT or AST) > 2.5 times upper limit of normal
- serum creatinine > 1.5 times upper limit of normal or urinary microalbumin >40 mg/L or eGFR < 60ml/min/1.73m2
Alcohol or illicit drug abuse
Pregnant, breastfeeding, or planning pregnancy during the study
Treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids
Hypothyroidism defined by elevated thyroid stimulating hormone (TSH) and low free thyroxine (fT4), or current hyperthyroidism under treatment
Participation in another weight loss clinical trial within past 3 months
Individuals who have lost >10% weight within past 3 months
Inability to read and write English
Subjects who frequently change smoking habits or who have stopped smoking within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking program at the time of screening will be eligible to start the trial after 3 months.
Subjects not willing to participate in all of the specimen collection.
Individuals with known penicillin and/or cephalosporin hypersensitivity will not be eligible for randomisation to the antibiotic treatment, however will still be eligible for entry into the trial

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 participants will come into the clinic for a screening visit. Once a participant is deemed eligible for randomisation, they will be allocated to a treatment group (i.e. High protein diet, Mediterranean diet, low fat (low GI) diet). Random group allocation will be performed by the study database upon entry of the participant’s details and determination of eligibility. The person who determines if a subject is eligible for inclusion in the trial is unaware, when the allocation is made, to which group the subject would be allocated. It will not be possible to override this allocation. Allocation is to be done by central randomisation with a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process will be completed by computer using a FileMaker Pro database that is password protected by The University of Sydney server. The process essentially works the same as ‘lotto’. The computer effectively picks a ball which is then taken out of the total allotment number (in this case n=108). This ensures that at the end of the randomisations, all 108 slots have been filled and there is no imbalance between groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/06/2012
Actual
15/06/2012
Date of last participant enrolment
Anticipated
Actual
4/09/2012
Date of last data collection
Anticipated
Actual
10/09/2013
Sample size
Target
108
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 285366 0
Government body
Name [1] 285366 0
National Health and Medical Research Council
Country [1] 285366 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 284220 0
None
Name [1] 284220 0
Address [1] 284220 0
Country [1] 284220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287381 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 287381 0
Ethics committee country [1] 287381 0
Australia
Date submitted for ethics approval [1] 287381 0
Approval date [1] 287381 0
04/06/2012
Ethics approval number [1] 287381 0
14547

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

Contacts
Principal investigator
Name 34257 0
A/Prof Andrew Holmes
Address 34257 0
School of Life and Environmental Sciences (SOLES)
Molecular Bioscience Building (G08)
The University of Sydney
NSW 2006 Australia
Country 34257 0
Australia
Phone 34257 0
+61293512530
Fax 34257 0
Email 34257 0
andrew.holmes@sydney.edu.au
Contact person for public queries
Name 17504 0
Nicholas Fuller
Address 17504 0
The Boden Institute, Faculty of Medicine and Health
Charles Perkins Centre D17, The University of Sydney
NSW 2006
Country 17504 0
Australia
Phone 17504 0
+61286271932
Fax 17504 0
Email 17504 0
nick.fuller@sydney.edu.au
Contact person for scientific queries
Name 8432 0
Andrew Holmes
Address 8432 0
School of Life and Environmental Sciences (SOLES)
Molecular Bioscience Building (G08)
The University of Sydney
NSW 2006 Australia
Country 8432 0
Australia
Phone 8432 0
+61293512530
Fax 8432 0
Email 8432 0
andrew.holmes@sydney.edu.au

No information has been provided regarding IPD availability


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.