Methods Study to Characterize Early Indicators of Weight Loss in People

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: caloric restriction - 10%; Behavioral: caloric restriction - 25%; Behavioral: caloric restriction - 50%; Behavioral: caloric restriction - Control

• Registration Number: NCT00383253
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-09-29
• Study Start: 2006-10
• Study First Submitted QC: 2006-10-02
• Study First Posted: 2006-10-03
• Study Completion: 2008-03
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-20
• Last Update Posted: 2009-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

Inclusion Criteria

• Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2

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Exclusion Criteria

• Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10%	caloric restriction - 10%	-
25%	caloric restriction - 25%	-
50%	caloric restriction - 50%	-
Control	caloric restriction - Control	-

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers	Throughout trial

Secondary Outcome Measures

Name	Time	Method
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	Throughout trial

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇺 North Adelaide, South Australia, Australia