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OpenTrials
Completed

NCT Number: NCT00383253

Methods Study to Characterize Early Indicators of Weight Loss in People

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

Completed

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

caloric restriction - Control

Behavioral

Subjects maintained on their baseline caloric intake (caloric restriction = none)

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Royal Adelaide Hospital
  • University of Adelaide

Registry information

Official study 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.

Important dates

Study start
2006
Study completion
2008
First posted
Oct 3, 2006
Registry last updated
Mar 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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