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

NCT01069458 | Completed

• 1 other identifier: 1375
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Overweight; Obesity

Keywords

Dietary intervention; Smoking cessation; Body weight

Outcome Measures

Primary Outcomes (1)

• Body weight and waist circumference

  4 weeks, 3 months and 6 months after smoking cessation

Secondary Outcomes (1)

• Resting metabolic rate, total energy expenditure, body composition, components of metabolic syndrome, eating behavior

  4 weeks

Study Arms (2)

The High Protein Diet Group

EXPERIMENTAL

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 Low Fat Diet Group

ACTIVE COMPARATOR

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

Interventions

The high protein diet group and the low fat diet group 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.

Also known as: The high protein diet group, The low fat diet group

The High Protein Diet Group; The Low Fat Diet Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking 10 cigarettes per day, BMI 25-40

You may not qualify if:

• Recent change in weight, contra-indications to use varenicline, a medication to assist smoking cessation

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Preventive Cardiology

Oslo, 0407, Norway

Location

Related Publications (1)

• 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.

  PMID: 28216282 DERIVED

MeSH Terms

Conditions

Smoking; Overweight; Obesity; Smoking Cessation; Body Weight

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior

Study Officials

• Serena Tonstad, Professor

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Consultant

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

NO (1)