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

NCT ID: NCT01069458

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-08-31

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.

Conditions

Smoking; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

The high protein diet group and the low fat diet group

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

The high protein diet group and the low fat diet group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

The high protein diet group; The low fat diet group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tor Ole Klemsdal

Chief Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serena Tonstad, Professor

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Department of Preventive Cardiology

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 28216282 (View on PubMed)

Other Identifiers

1375

Identifier Type: -

Identifier Source: org_study_id