This study will measure the changes that indicate successful weight loss in people.
Official 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.
Conditions
Obesity
Study Type
Interventional
Study Design
Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Further Details
Primary Outcome Measures:
- To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers
Secondary Outcome Measures:
- 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
Study Start
October 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years – 55 Years
- Genders Eligible for Study: Male
Inclusion Criteria:
- Subjects >=18 years of age
- BMI >= 30 and < 40 kg/m2
Exclusion Criteria:
- Females
- Those with illnesses expected to cause weightloss
- Those without stable body weight within 3 months of screening.
Total Enrolment
48
Contact Details
Locations:
- Adelaide, South Australia, 5000, Australia; Recruiting
- North Adelaide, South Australia, 5006, Australia; Recruiting
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