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Completed

NCT Number: NCT02091193

Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effects of krill oil supplementation in patients with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements.

Patients who enroll in this study will be asked to visit the Western Connecticut Health Network Biomedical Research Institute on 3 separate occasions: for baseline testing, after 4 weeks of supplementing with krill oil, and after 4 weeks of supplementing with a placebo. Patients will be randomized into one of two groups to determine the order in which they receive the supplement and placebo. Every patient will receive both the krill oil and the placebo, but both the coordinator and the patient are blinded to which is which. At each visit, participants will undergo a non-invasive test which measures the function of the inner lining of blood vessels and they will also have blood drawn. Fasting is required before each appointment. The blood drawn is used to measure their Hemoglobin A1C, Glucose, HDL, LDL, total cholesterol, C-peptide and total antioxidant capacity.

Risks to taking krill oil supplements are likely to include bad breath, heartburn, fishy taste, upset stomach, nausea, loose stools, gas, and bloating. Risks of EndoPAT testing are not permanent and may include pain, numbness, tingling, redness, and bruising at the site of the blood pressure cuff. Risks that are associated with drawing blood may include redness, swelling, pain or discomfort, bruising at the site of the needle stick, or in very rare cases, infection at the needle site. To minimize these risks, trained technologists and phlebotomists will be used for all procedures.

This is not a treatment option; while involved in this study all participants will continue their regular treatment for Type 2 diabetes mellitus (as well as any other applicable conditions).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Type 2 Diabetes Mellitus
  • Stable on glucose lowering agents

Exclusion criteria

  • Age of less than 18
  • Currently pregnant or lactating
  • Blood coagulation disorder or taking oral anticoagulants other than aspirin
  • Seafood allergy
  • Presently taking fish oil or krill oil supplements

Treatment and study plan

Krill Oil (Supplement A)

Dietary Supplement

Other names: Prograde, Inc. Krill Oil

Placebo (Supplement B)

Dietary Supplement

Primary outcomes

  1. Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo

    Time frame: Three Months

Secondary outcomes

  1. Change in Lipid Profile (HDL, LDL, Total Cholesterol), Glucose, Hemoglobin A1C with Krill Oil Supplementation Compared with Baseline and Placebo

    Time frame: Three months

Other outcomes

  1. Change C-Peptide and Total Antioxidant Capacity of Serum Compared with Baseline and Placebo

    Time frame: Three Months

  2. Effects of Longer Term Krill Oil Supplementation compared to Baseline on Endothelial function, lipid profile, Hemoglobin A1C, glucose, c-peptide and total antioxidant capacity.

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

Danbury Hospital

Other

Collaborators

  • Prograde Nutrition

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2014
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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