Fish Oils and Adipose Inflammation Reduction

NCT02010359 | Completed Phase 4 Results DMC

• 1 other identifier: 1K23DK095913-01A1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical trial designed to assess whether fish oil treatments are effective in the prevention of obesity-related fat tissue (adipose) inflammation. Specifically it addresses the hypothesis that fish oils treatments will reduce signaling by chemokine pathways (fractalkine and MCP-1) important in adipose tissue for the recruitment and activation of certain white blood cells (macrophages). The study is a double-blind placebo-controlled trial of the fish oil Lovaza from GlaxoSmithKline (omega-3-acid ethyl esters; a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) in obese non-diabetic adults, to determine if Lovaza decreases markers of inflammation and macrophage activation in adipose and blood and understand the mechanism by which fish oils affect inflammation.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Fractalkine Levels

  Quantification of fractalkine levels in plasma at baseline and after 8 weeks of Lovaza or placebo will be compared.

  Baseline and 8 weeks

Secondary Outcomes (9)

• Change in Plasma Interleukin 6 (IL-6)

  Baseline and 8 weeks

• Change in Plasma Monocyte Chemotactic Protein-1 (MCP-1)

  Baseline and 8 weeks

• Change in Plasma Tumor Necrosis Factor Alpha (TNFalpha)

  Baseline and 8 weeks

• Change in the Ratio of Circulating Monocyte Subpopulations

  baseline and 8 weeks

• Change in mRNA Expression of Fractalkine in Adipose

  Baseline and 8 weeks

Study Arms (2)

Lovaza

EXPERIMENTAL

Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks

Drug: Lovaza

Placebo

PLACEBO COMPARATOR

An inactive Placebo (2 pills twice daily) will be given for 8 weeks

Drug: Placebo

Interventions

Lovaza DRUG

Lovaza 4 grams per day

Lovaza

Placebo DRUG

Placebo pill

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and non-pregnant/lactating women between the ages of 25 and 50.
• Body Mass Index (BMI) ≥30 kg/m2
• Participants who are able to give written informed consent and willing to comply with all study-related procedures.

You may not qualify if:

• Diabetes Mellitus (glucose fasting \>126, or random \>200, Hemoglobin A1C\>6.5 %, or use of any anti-diabetic agent)
• Self-reported fish or shellfish allergy
• Planned usage of any prescription or non-prescription medication (other than contraceptive pills or devices) during the study period.
• Recent (within 6 months) use of fish oil supplements or self- reported dietary intake of \>3 servings of fish/month
• Blood pressure \>140/90
• Recent (within 6 months) use of statins, niacin, or fenofibrates
• Current or planned pregnancy/lactation. Pre-menopausal women unwilling to prevent pregnancy by use of the following approved contraceptive strategies: diaphragm, cervical cap, condom with spermicide, surgical sterility, birth control pills, Depo-Provera injection, Intra-uterine device, progestin implant, or abstinence.
• History of liver disease or abnormal liver function tests (aspartate aminotransferase, Alanine transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase \> 1.5x Upper Limit normal; bilirubin \> 2x upper limit normal) at Screening Visit
• Men who are unwilling to limit alcohol consumption to \< 14 alcoholic drinks per week or \< 4 alcoholic drinks per occasion while participating in the study
• Women who are unwilling to limit alcohol consumption to \< 7 alcoholic drinks per week or \< 3 alcoholic drinks per occasion while participating in the study.
• Hemoglobin less than 11.0 g/dL
• Any reported arrhythmia, usage of anti-arrhythmic therapy, or abnormal screening electrocardiogram
• Known bleeding disorder or coagulopathy
• Any major active rheumatologic, pulmonary, hematologic or dermatologic disease or inflammatory condition or minor active infection
• Self-reported history of HIV positive

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Shah RD, Tang ZZ, Chen G, Huang S, Ferguson JF. Soy food intake associates with changes in the metabolome and reduced blood pressure in a gut microbiota dependent manner. Nutr Metab Cardiovasc Dis. 2020 Aug 28;30(9):1500-1511. doi: 10.1016/j.numecd.2020.05.001. Epub 2020 May 18.

  PMID: 32620337 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Omacor

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Rachana Shah
• Organization: Children's Hospital of Philadelphia

shahr@email.chop.edu

215-590-3390

Study Officials

• Rachana Shah, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 12, 2019
• Results First Posted: January 14, 2019

Record last verified: 2019-01

Locations

US (1)