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

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069458
• Other study ID #: 1375
• Status: Completed
• Phase: N/A
• First received: February 15, 2010
• Last updated: June 28, 2017
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: June 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Smoking

Intervention

Other:
• The high protein diet group and the low fat diet group
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.

Locations

Country	Name	City	State
Norway	Department of Preventive Cardiology	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight and waist circumference		4 weeks, 3 months and 6 months after smoking cessation
Secondary	Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior		4 weeks