Methods Study to Characterize Early Indicators of Weight Loss in People

N/ACompletedNCT00383253

Pfizer57 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

caloric restriction - 10%BEHAVIORAL

Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)

caloric restriction - 25%BEHAVIORAL

Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)

caloric restriction - 50%BEHAVIORAL

Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Adelaide, South Australia, Australia

Pfizer Investigational Site

North Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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