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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