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
Recruitment status was Recruiting
Sponsor:
Ullevaal University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01069458
First received: February 15, 2010
Last updated: April 18, 2011
Last verified: April 2011
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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:
|
|
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:
|
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
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 Smoking Overweight |
Signs and Symptoms Overnutrition Nutrition Disorders Habits |
ClinicalTrials.gov processed this record on June 17, 2013