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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01069458
First received: February 15, 2010
Last updated: April 18, 2011
Last verified: April 2011
  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 dietary protein on resting 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of 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 Oslo University Hospital:

Primary Outcome Measures:
  • Body weight and waist circumference [ Time Frame: 4 weeks, 3 months and 6 months after smoking cessation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (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)
Other: The high protein diet group and the low fat diet group
The high protein diet (25 energy percent from protein, 55 energy percent from fat, 20 energy percent from carbohydrate) and the low fat diet (30 energy percent from fat, 20 energy percent from protein, 50 energy percent from carbohydrate)
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 percent from fat, 20 energy percent from protein, 50 energy percent from carbohydrate)
Other: The high protein diet group and the low fat diet group
The high protein diet (25 energy percent from protein, 55 energy percent from fat, 20 energy percent from carbohydrate) and the low fat diet (30 energy percent from fat, 20 energy percent from protein, 50 energy percent from carbohydrate)
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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069458

Contacts
Contact: Mette Svendsen, Phd 4723016653 mette.svendsen@uus.no
Contact: Eli Heggen, MD 4722119982 eli.heggen@uus.no

Locations
Norway
Department of Preventive Cardiology Recruiting
Oslo, Norway, 0407
Contact: Mette Svendsen, P    4723016653    mette.svendsen@uus.no   
Contact: Eli Heggen, MD    4722119982    eli.heggen@us.no   
Principal Investigator: Serena Tonstad, Professor         
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Serena Tonstad, Professor Oslo University Hospital Ullevaal
  More Information

No publications provided

Responsible Party: Oslo University Hospital Ullevaal, N-0407 OSLO, NORWAY, Department of Preventive Cardiology, Oslo University Hospital Ullevaal, N-0407 OSLO, NORWAY
ClinicalTrials.gov Identifier: NCT01069458     History of Changes
Other Study ID Numbers: 1375
Study First Received: February 15, 2010
Last Updated: April 18, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Dietary intervention
Smoking cessation
Body weight

Additional relevant MeSH terms:
Body Weight
Obesity
Overweight
Signs and Symptoms
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 01, 2014