Obesity
Conditions
Brief summary
Methods study to characterize early indicators of weight loss in people.
Interventions
BEHAVIORALcaloric restriction - 10%
Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
BEHAVIORALcaloric restriction - 25%
Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
BEHAVIORALcaloric restriction - 50%
Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
BEHAVIORALcaloric restriction - Control
Subjects maintained on their baseline caloric intake (caloric restriction = none)
Sponsors
University of Adelaide
Royal Adelaide Hospital
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subjects \>=18 years of age with BMI \>= 30 and \< 40 kg/m2
Exclusion criteria
* Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers | Throughout trial |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Throughout trial |
Countries
Australia
Outcome results
None listed