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Clinical Trials/NCT01069458
NCT01069458
Completed
Not Applicable

The Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight and Composition, Total Energy Expenditure, Metabolic Risk Factors and Eating Behavior After Smoking Cessation

Oslo University Hospital1 site in 1 country122 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking
Sponsor
Oslo University Hospital
Enrollment
122
Locations
1
Primary Endpoint
Body weight and waist circumference
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to determine whether subjects following a high protein diet will gain less in weight after smoking cessation compared to subjects following a low fat diet due to the effects of protein on metabolic rate and hunger.

Detailed Description

Sustained smoking cessation is one of the most effective therapies to avoid premature morbidity and mortality. However, weight gain associated with nicotine withdrawal may attenuate some of the beneficial health effects and is cited as a major obstacle to quit smoking. The mechanism for the weight gain is not elucidated but reduced resting metabolic rate, reduced total energy expenditure, increased caloric intake and changes in fat metabolism may be involved. Elucidating effective strategies to prevent or reduce post-cessation weight gain may improve health outcomes of smoking cessation.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
August 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tor Ole Klemsdal

Chief Consultant

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Smoking 10 cigarettes per day, BMI 25-40

Exclusion Criteria

  • Recent change in weight, contra-indications to use varenicline, a medication to assist smoking cessation

Outcomes

Primary Outcomes

Body weight and waist circumference

Time Frame: 4 weeks, 3 months and 6 months after smoking cessation

Secondary Outcomes

  • Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior(4 weeks)

Study Sites (1)

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