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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Obesity; Overweight
• Intervention / Treatment: Other: The high protein diet group and the low fat diet group

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Department of Preventive Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The High Protein 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.	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.; Other Names: The high protein diet group; The low fat diet group
Active Comparator: 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.	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.; Other Names: The high protein diet group; The low fat diet group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight and waist circumference	4 weeks, 3 months and 6 months after smoking cessation

Secondary Outcome Measures

Outcome Measure	Time Frame
Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior	4 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Serena Tonstad, Professor, Oslo University Hospital

Publications and helpful links

General Publications

• Heggen E, Svendsen M, Tonstad S. Smoking cessation improves cardiometabolic risk in overweight and obese subjects treated with varenicline and dietary counseling. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):335-341. doi: 10.1016/j.numecd.2016.12.011. Epub 2017 Jan 4.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 15, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Smoking cessation; Body weight; Dietary intervention
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: 1375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED