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Effects of Omega-3 Fatty Acids on Markers of Inflammation

Primary Purpose

Obesity, Hypertriglyceridemia, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fish Oil
Flaxseed Oil
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Fish oil, Omega-3 fatty acids, Metabolic syndrome, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Gender:

  • 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

No known active psychiatric illness.

Exclusion Criteria:Daily intake of dietary supplements containing omega-3 FAs within the past month.

  • 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
    • Lipid lowering drugs including statins
    • Anti-hypertensive drugs
    • Anti-coagulant drugs
  • Body Mass Index (BMI) greater than or equal to 40.
  • Pregnant or Lactating
  • Inability to communicate effectively with study personnel

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low-dose Flaxseed Oil

High-dose Flaxseed Oil

Low-dose Fish Oil

High-dose Fish Oil

Placebo

Arm Description

2.2 g ALA (alpha-linolenic acid) per day

6.6 g ALA (alpha-linolenic acid) per day

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

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

4 g or 6 g soybean oil per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Change from baseline in triglycerides at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline

Full Information

First Posted
May 20, 2010
Last Updated
February 18, 2023
Sponsor
Stanford University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01129050
Brief Title
Effects of Omega-3 Fatty Acids on Markers of Inflammation
Official Title
Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The primary aim 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. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertriglyceridemia, Insulin Resistance, Hypertension
Keywords
Fish oil, Omega-3 fatty acids, Metabolic syndrome, Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose Flaxseed Oil
Arm Type
Experimental
Arm Description
2.2 g ALA (alpha-linolenic acid) per day
Arm Title
High-dose Flaxseed Oil
Arm Type
Experimental
Arm Description
6.6 g ALA (alpha-linolenic acid) per day
Arm Title
Low-dose Fish Oil
Arm Type
Experimental
Arm Description
1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day
Arm Title
High-dose Fish Oil
Arm Type
Experimental
Arm Description
3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 g or 6 g soybean oil per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
Fish oil capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed Oil
Intervention Description
Flaxseed oil capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Soybean oil capsule
Primary Outcome Measure Information:
Title
Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.
Description
Change was calculated as the value at 8 weeks minus the value at baseline
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.
Description
Change was calculated as the value at 8 weeks minus the value at baseline
Time Frame
Baseline and 8 weeks
Title
Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.
Description
Change was calculated as the value at 8 weeks minus the value at baseline
Time Frame
Baseline and 8 weeks
Title
Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.
Description
Change was calculated as the value at 8 weeks minus the value at baseline
Time Frame
Baseline and 8 weeks
Title
Change from baseline in triglycerides at 8 weeks.
Description
Change was calculated as the value at 8 weeks minus the value at baseline
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Gender: 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 No known active psychiatric illness. Exclusion Criteria:Daily intake of dietary supplements containing omega-3 FAs within the past month. 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 Lipid lowering drugs including statins Anti-hypertensive drugs Anti-coagulant drugs Body Mass Index (BMI) greater than or equal to 40. Pregnant or Lactating Inability to communicate effectively with study personnel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Gardner
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22031659
Citation
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.
Results Reference
result
Links:
URL
https://med.stanford.edu/nutrition/research/completed-studies/plant-vs-marine-omega-3s.html
Description
Study description and summary of results

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Effects of Omega-3 Fatty Acids on Markers of Inflammation

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