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NCT Number: NCT01069458

The Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight After Smoking Cessation

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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Preventive Cardiology

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

The high protein diet group and the low fat diet group

Other

The High Protein Diet Group was advised to have 25 energy percent from protein, 55 energy percent from fat, 20 energy percent from carbohydrate in the diet and the Low Fat Diet Group was advised to have 30 energy percent from fat, 20 energy percent from protein, 50 energy percent from carbohydrate in the diet.

Other names: The high protein diet group, The low fat diet group

Primary outcomes

  1. Body weight and waist circumference

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

Secondary outcomes

  1. Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2010
Registry last updated
Jun 29, 2017

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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