Effects of Omega-3 Fatty Acids on Markers of Inflammation

NCT01129050 | Completed

• 2 other identifiers: SU-05042010-5842R21AT003465-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.

Conditions

Obesity; Hypertriglyceridemia; Insulin Resistance; Hypertension

Keywords

Fish oil; Omega-3 fatty acids; Metabolic syndrome; Adults

Outcome Measures

Primary Outcomes (1)

• Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.

  Change was calculated as the value at 8 weeks minus the value at baseline

  Baseline and 8 weeks

Secondary Outcomes (4)

• Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.

  Baseline and 8 weeks

• Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.

  Baseline and 8 weeks

• Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.

  Baseline and 8 weeks

• Change from baseline in triglycerides at 8 weeks.

  Baseline and 8 weeks

Study Arms (5)

Low-dose Flaxseed Oil

EXPERIMENTAL

2.2 g ALA (alpha-linolenic acid) per day

Dietary Supplement: Flaxseed Oil

High-dose Flaxseed Oil

EXPERIMENTAL

6.6 g ALA (alpha-linolenic acid) per day

Dietary Supplement: Flaxseed Oil

Low-dose Fish Oil

EXPERIMENTAL

1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day

Dietary Supplement: Fish Oil

High-dose Fish Oil

EXPERIMENTAL

3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day

Dietary Supplement: Fish Oil

Placebo

PLACEBO COMPARATOR

4 g or 6 g soybean oil per day

Dietary Supplement: Placebo

Interventions

Fish Oil DIETARY_SUPPLEMENT

Fish oil capsule

High-dose Fish Oil; Low-dose Fish Oil

Flaxseed Oil DIETARY_SUPPLEMENT

Flaxseed oil capsule

High-dose Flaxseed Oil; Low-dose Flaxseed Oil

Placebo DIETARY_SUPPLEMENT

Soybean oil capsule

Placebo

Eligibility Criteria

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

You may qualify if:

• Both women and men
• Age: \> or = 18 years
• Ethnicity and race: All ethnic and racial backgrounds welcome
• As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
• Central obesity as measured by waist circumference:
• Men: Greater than 40 inches
• Women: Greater than 35 inches
• Fasting blood triglycerides greater than or equal to 150 mg/dL
• Blood HDL cholesterol:
• Men: Less than 40 mg/dL
• Women: Less than 50 mg/dL
• Blood pressure greater than or equal to 130/85 mmHg
• Fasting glucose greater than or equal to 100 mg/dL
• Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation
• Ability and willingness to give written informed consent

You may not qualify if:

• Fasting blood glucose \> 140 mg/dL
• Significant liver enzyme abnormality
• AST or ALT more than 2 times the upper limit of normal and/or
• Bilirubin more than 50% the upper limit of normal
• Renal disease as measured at baseline:
• Serum creatinine \> 1.30 mg/dL, or
• Calculated creatinine clearance \< 71 mL/min
• Self reported personal history of:
• Clotting disorders
• Clinically significant atherosclerosis (e.g., CAD, PAD)
• Malignant neoplasm
• Ongoing infection
• Inflammatory disease (e.g., rheumatoid arthritis)
• Subjects currently receiving the following medications (self report):
• Anti-Inflammatory drugs

Sponsors & Collaborators

• Stanford University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Dewell A, Marvasti FF, Harris WS, Tsao P, Gardner CD. Low- and high-dose plant and marine (n-3) fatty acids do not affect plasma inflammatory markers in adults with metabolic syndrome. J Nutr. 2011 Dec;141(12):2166-71. doi: 10.3945/jn.111.142240. Epub 2011 Oct 26.

  PMID: 22031659 RESULT

Related Links

• Study description and summary of results

MeSH Terms

Conditions

Obesity; Hypertriglyceridemia; Insulin Resistance; Hypertension; Metabolic Syndrome

Interventions

Fish Oils; Linseed Oil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Fats, Unsaturated; Fats; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Christopher D Gardner

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Research)

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)