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

Not Applicable

Completed

• Conditions: Smoking; Overweight; Obesity
• Interventions: Other: The high protein diet group and the low fat diet group

• Registration Number: NCT01069458
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-15
• Study First Posted: 2010-02-17
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Low Fat Diet Group	The high protein diet group and the low fat diet group	The low fat diet (30% energy from fat, 20% energy from protein, 50% energy percent from carbohydrate) will be hypo-caloric and achieved by choosing low-fat diary and meat products, restricting amounts of visible fat and fatty snacks and increasing intake of whole meal bread, muesli, brown rice, whole meal pasta in the main meals and by choosing yoghurt with muesli, oat porridge with milk, fruits and hard bread with jam and soft gout-cheese as snacks.
The High Protein Diet Group	The high protein diet group and the low fat diet group	The high protein diet (25% energy from protein, 55% energy from fat, 20% energy from carbohydrate) will be hypo-caloric and achieved by restricting the amount of sugar containing foods and drinks, reducing the intake of bread, rice, pasta, fruits and fruit-juices and increasing the intake of vegetables (instead of bread, rice, pasta and potatoes) and increasing the amounts of protein (from chicken, fish, and meat) and fat from oil and dressings for lunch and dinner and by choosing nuts and protein-rich yoghurts, egg, cheese, chicken wings, shellfish, fish and fish products as snacks.

Primary Outcome Measures

Name	Time	Method
Body weight and waist circumference	4 weeks, 3 months and 6 months after smoking cessation

Secondary Outcome Measures

Name	Time	Method
Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior	4 weeks

Trial Locations

Locations (1)

Department of Preventive Cardiology; 🇳🇴 Oslo, Norway