Methods Study to Characterize Early Indicators of Weight Loss in People
This study has been completed.
Sponsor:
Pfizer
Collaborators:
University of Adelaide
Royal Adelaide Hospital
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00383253
First received: September 29, 2006
Last updated: March 20, 2009
Last verified: March 2009
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Purpose
Methods study to characterize early indicators of weight loss in people.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: caloric restriction - 10% Behavioral: caloric restriction - 25% Behavioral: caloric restriction - 50% Behavioral: caloric restriction - Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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 [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]
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 [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]
| Enrollment: | 57 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2008 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 10% |
Behavioral: caloric restriction - 10%
Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
|
| Experimental: 25% |
Behavioral: caloric restriction - 25%
Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
|
| Experimental: 50% |
Behavioral: caloric restriction - 50%
Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
|
| Placebo Comparator: Control |
Behavioral: caloric restriction - Control
Subjects maintained on their baseline caloric intake (caloric restriction = none)
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383253
Locations
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Pfizer Investigational Site | |
| North Adelaide, South Australia, Australia, 5006 | |
Sponsors and Collaborators
Pfizer
University of Adelaide
Royal Adelaide Hospital
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00383253 History of Changes |
| Other Study ID Numbers: | A9001342 |
| Study First Received: | September 29, 2006 |
| Last Updated: | March 20, 2009 |
| Health Authority: | Australia: Human Research Ethics Committee |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013