Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02091193
Enrollment
47
Registered
2014-03-19
Start date
2012-03-31
Completion date
2013-12-31
Last updated
2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes Mellitus

Keywords

Krill Oil, Endothelial Function, Type II Diabetes Mellitus

Brief summary

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).

Interventions

DIETARY_SUPPLEMENTKrill Oil (Supplement A)
DIETARY_SUPPLEMENTPlacebo (Supplement B)

Sponsors

Prograde Nutrition
CollaboratorUNKNOWN
Danbury Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and PlaceboThree Months

Secondary

MeasureTime frame
Change in Lipid Profile (HDL, LDL, Total Cholesterol), Glucose, Hemoglobin A1C with Krill Oil Supplementation Compared with Baseline and PlaceboThree months

Other

MeasureTime frame
Change C-Peptide and Total Antioxidant Capacity of Serum Compared with Baseline and PlaceboThree Months
Effects of Longer Term Krill Oil Supplementation compared to Baseline on Endothelial function, lipid profile, Hemoglobin A1C, glucose, c-peptide and total antioxidant capacity.17 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026