Methods Study to Characterize Early Indicators of Weight Loss in People

March 20, 2009 updated by: Pfizer

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.

Methods study to characterize early indicators of weight loss in people.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
      • North Adelaide, South Australia, Australia, 5006
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Behavioral: caloric restriction - Control
Subjects maintained on their baseline caloric intake (caloric restriction = none)
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)

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Throughout trial
Throughout trial

Secondary Outcome Measures

Outcome 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
Time Frame: Throughout trial
Throughout trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

University of Adelaide
Royal Adelaide Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 29, 2006

First Submitted That Met QC Criteria

October 2, 2006

First Posted (Estimate)

October 3, 2006

Study Record Updates

Last Update Posted (Estimate)

March 23, 2009

Last Update Submitted That Met QC Criteria

March 20, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9001342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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