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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
57
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/ct2/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