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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069458
First Posted: February 17, 2010
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tor Ole Klemsdal, Oslo University Hospital
  Purpose
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.

Condition Intervention
Smoking Overweight Obesity Other: The high protein diet group and the low fat diet group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tor Ole Klemsdal, Oslo University Hospital:

Primary Outcome Measures:
  • Body weight and waist circumference [ Time Frame: 4 weeks, 3 months and 6 months after smoking cessation ]

Secondary Outcome Measures:
  • Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior [ Time Frame: 4 weeks ]

Enrollment: 122
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069458


Locations
Norway
Department of Preventive Cardiology
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Serena Tonstad, Professor Oslo University Hospital
  More Information

Responsible Party: Tor Ole Klemsdal, Chief Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01069458     History of Changes
Other Study ID Numbers: 1375
First Submitted: February 15, 2010
First Posted: February 17, 2010
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tor Ole Klemsdal, Oslo University Hospital:
Dietary intervention
Smoking cessation
Body weight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms


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