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Methods Study to Characterize Early Indicators of Weight Loss in People

This study has been completed.
University of Adelaide
Royal Adelaide Hospital
Information provided by:
Pfizer Identifier:
First received: September 29, 2006
Last updated: March 20, 2009
Last verified: March 2009
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
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 ]

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 ]

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)


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00383253     History of Changes
Other Study ID Numbers: A9001342
Study First Received: September 29, 2006
Last Updated: March 20, 2009

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on June 22, 2017