Methods Study to Characterize Early Indicators of Weight Loss in People

This study has been completed.
Sponsor:
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
  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
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 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 September 30, 2014