Fish Oil and Inflammation in Overweight Subjects

NCT00885053 | Completed

• 1 other identifier: ADIPOMEGA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of acute and short-term intervention with fish oil on inflammatory markers in overweight subjects.

Conditions

Overweight

Keywords

Inflammation; Fatty acids, Omega 3; Leukotrienes; Adiponectin; Adipose tissue; RNA, Messenger

Outcome Measures

Primary Outcomes (1)

• To assess the effect of 1 g/day of n-3 polyunsaturated fatty acids on inflammatory markers

  After 1 day and after 6 weeks intervention

Secondary Outcomes (2)

• To assess effect of 1 g n-3 polyunsaturated fatty acids (daily dose) on the fatty acid profile of plasma, leucocytes and adipose tissue.

  After 1 day and 6 after weeks of intervention

• To assess the effect of 1g n-3 polyunsaturated fatty acids (daily dose) on the gene expression profile (mRNA) - especially genes involved in encoding the inflammatory response.

  After 1 day and 6 after weeks of intervention

Study Arms (2)

Fish oil

EXPERIMENTAL

Dietary Supplement: fish oil

Olive oil

PLACEBO COMPARATOR

Dietary Supplement: olive oil

Interventions

fish oil DIETARY_SUPPLEMENT

Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks

Fish oil

olive oil DIETARY_SUPPLEMENT

Capsules. Approximately 1 g olive oil daily. One day + 6 weeks

Olive oil

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist circumference ≥ 80 cm (females) or ≥ 94 cm (males)
• Postmenopausal (females)

You may not qualify if:

• Daily intake of fish oil capsules
• Daily intake of NSAIDs
• HbA1c ≥ 8%
• Serum creatinine ≤ 30 mL/min
• Chronic inflammatory disease
• Other serious illness
• Inability to informed consent

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg Hospital, Aarhus University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (8)

• Hajer GR, van Haeften TW, Visseren FL. Adipose tissue dysfunction in obesity, diabetes, and vascular diseases. Eur Heart J. 2008 Dec;29(24):2959-71. doi: 10.1093/eurheartj/ehn387. Epub 2008 Sep 5.

  PMID: 18775919 BACKGROUND

• Balkau B, Deanfield JE, Despres JP, Bassand JP, Fox KA, Smith SC Jr, Barter P, Tan CE, Van Gaal L, Wittchen HU, Massien C, Haffner SM. International Day for the Evaluation of Abdominal Obesity (IDEA): a study of waist circumference, cardiovascular disease, and diabetes mellitus in 168,000 primary care patients in 63 countries. Circulation. 2007 Oct 23;116(17):1942-51. doi: 10.1161/CIRCULATIONAHA.106.676379.

  PMID: 17965405 BACKGROUND

• Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.

  PMID: 11877368 BACKGROUND

• Calder PC. n-3 polyunsaturated fatty acids, inflammation, and inflammatory diseases. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1505S-1519S. doi: 10.1093/ajcn/83.6.1505S.

  PMID: 16841861 BACKGROUND

• Schmidt EB, Arnesen H, de Caterina R, Rasmussen LH, Kristensen SD. Marine n-3 polyunsaturated fatty acids and coronary heart disease. Part I. Background, epidemiology, animal data, effects on risk factors and safety. Thromb Res. 2005;115(3):163-70. doi: 10.1016/j.thromres.2004.09.006.

  PMID: 15617737 BACKGROUND

• Schmidt EB, Arnesen H, Christensen JH, Rasmussen LH, Kristensen SD, De Caterina R. Marine n-3 polyunsaturated fatty acids and coronary heart disease: Part II. clinical trials and recommendations. Thromb Res. 2005;115(4):257-62. doi: 10.1016/j.thromres.2004.09.007. No abstract available.

  PMID: 15668184 BACKGROUND

• Browning LM, Krebs JD, Moore CS, Mishra GD, O'Connell MA, Jebb SA. The impact of long chain n-3 polyunsaturated fatty acid supplementation on inflammation, insulin sensitivity and CVD risk in a group of overweight women with an inflammatory phenotype. Diabetes Obes Metab. 2007 Jan;9(1):70-80. doi: 10.1111/j.1463-1326.2006.00576.x.

  PMID: 17199721 BACKGROUND

• Kris-Etherton PM, Harris WS, Appel LJ; AHA Nutrition Committee. American Heart Association. Omega-3 fatty acids and cardiovascular disease: new recommendations from the American Heart Association. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):151-2. doi: 10.1161/01.atv.0000057393.97337.ae. No abstract available.

  PMID: 12588750 BACKGROUND

MeSH Terms

Conditions

Overweight; Inflammation

Interventions

Fish Oils; Olive Oil

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 26, 2010

Record last verified: 2009-12

Locations

DK (1)