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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00383253




Registration number
NCT00383253
Ethics application status
Date submitted
29/09/2006
Date registered
3/10/2006
Date last updated
23/03/2009

Titles & IDs
Public title
Methods Study to Characterize Early Indicators of Weight Loss in People
Scientific title
A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.
Secondary ID [1] 0 0
A9001342
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - caloric restriction - 10%
Behaviour - caloric restriction - 25%
Behaviour - caloric restriction - 50%
Behaviour - caloric restriction - Control

Experimental: 10% -

Experimental: 25% -

Experimental: 50% -

Placebo Comparator: Control -


Behaviour: caloric restriction - 10%
Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)

Behaviour: caloric restriction - 25%
Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)

Behaviour: caloric restriction - 50%
Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)

Behaviour: caloric restriction - Control
Subjects maintained on their baseline caloric intake (caloric restriction = none)

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers
Timepoint [1] 0 0
Throughout trial
Secondary outcome [1] 0 0
To evaluate the time course, magnitude and biomarkers of metabolic compensation as well as assessment of well being (via questionnaires) following varying degrees of controlled, 1-month, caloric restriction
Timepoint [1] 0 0
Throughout trial

Eligibility
Key inclusion criteria
- Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Females, those with illnesses expected to cause weight loss, those without stable body
weight within 3 months of screening.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [2] 0 0
Pfizer Investigational Site - North Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Adelaide
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Adelaide Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Methods study to characterize early indicators of weight loss in people.
Trial website
https://clinicaltrials.gov/show/NCT00383253
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications