Back to resultsThe Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight After Smoking Cessation
Primary Purpose
Smoking, Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The high protein diet group and the low fat diet group
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring Dietary intervention, Smoking cessation, Body weight
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
Sites / Locations
- Department of Preventive Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The High Protein Diet Group
The Low Fat Diet Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Body weight and waist circumference
Secondary Outcome Measures
Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior
Full Information
NCT ID
NCT01069458
First Posted
February 15, 2010
Last Updated
June 28, 2017
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01069458
Brief Title
The Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight After Smoking Cessation
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Overweight, Obesity
Keywords
Dietary intervention, Smoking cessation, Body weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The High Protein Diet Group
Arm Type
Experimental
Arm Description
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.
Arm Title
The Low Fat Diet Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The high protein diet group and the low fat diet group
Other Intervention Name(s)
The high protein diet group, The low fat diet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight and waist circumference
Time Frame
4 weeks, 3 months and 6 months after smoking cessation
Secondary Outcome Measure Information:
Title
Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serena Tonstad, Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Preventive Cardiology
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28216282
Citation
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.
Results Reference
derived
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The Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight After Smoking Cessation
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