Methods Study to Characterize Early Indicators of Weight Loss in People

Pfizer

Status: Completed

Conditions: Obesity

Treatments: Behavioral: caloric restriction - 25%; Behavioral: caloric restriction - 50%; Behavioral: caloric restriction - Control; Behavioral: caloric restriction - 10%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00383253

A9001342

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 4 patient groups, including a placebo group

10%

Experimental group

Treatment:

Behavioral: caloric restriction - 10%

25%

Experimental group

Treatment:

Behavioral: caloric restriction - 25%

50%

Experimental group

Treatment:

Behavioral: caloric restriction - 50%

Control

Placebo Comparator group

Treatment:

Behavioral: caloric restriction - Control