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Methods Study to Characterize Early Indicators of Weight Loss in People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00383253
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : March 23, 2009
Information provided by:

Study Description
Brief Summary:
Methods study to characterize early indicators of weight loss in people.

Condition or disease Intervention/treatment
Obesity Behavioral: caloric restriction - 10% Behavioral: caloric restriction - 25% Behavioral: caloric restriction - 50% Behavioral: caloric restriction - Control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2006
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383253

Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Pfizer Investigational Site
North Adelaide, South Australia, Australia, 5006
Sponsors and Collaborators
University of Adelaide
Royal Adelaide Hospital
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00383253     History of Changes
Other Study ID Numbers: A9001342
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: March 23, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms