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

Type II Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091193
• Other study ID #: 12-02-34-334
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: August 8, 2016
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2016
• Source: Danbury Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Dietary Supplement:
• Krill Oil (Supplement A)

• Placebo (Supplement B)

Locations

Country	Name	City	State
United States	Danbury Hospital	Danbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Danbury Hospital	Prograde Nutrition

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bunea R, El Farrah K, Deutsch L. Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Altern Med Rev. 2004 Dec;9(4):420-8. — View Citation

Maki KC, Reeves MS, Farmer M, Griinari M, Berge K, Vik H, Hubacher R, Rains TM. Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Nutr Res. 2009 Sep;29(9):609-15. doi: 10.1016/j.nutres.2009.09.004. — View Citation

Wijendran V, Huang MC, Diau GY, Boehm G, Nathanielsz PW, Brenna JT. Efficacy of dietary arachidonic acid provided as triglyceride or phospholipid as substrates for brain arachidonic acid accretion in baboon neonates. Pediatr Res. 2002 Mar;51(3):265-72. — View Citation

Wong CY, Yiu KH, Li SW, Lee S, Tam S, Lau CP, Tse HF. Fish-oil supplement has neutral effects on vascular and metabolic function but improves renal function in patients with Type 2 diabetes mellitus. Diabet Med. 2010 Jan;27(1):54-60. doi: 10.1111/j.1464-5491.2009.02869.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change C-Peptide and Total Antioxidant Capacity of Serum Compared with Baseline and Placebo		Three Months	No
Other	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	No
Primary	Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo		Three Months	No
Secondary	Change in Lipid Profile (HDL, LDL, Total Cholesterol), Glucose, Hemoglobin A1C with Krill Oil Supplementation Compared with Baseline and Placebo		Three months	No

External Links

•   Prograde, Inc Krill Oil Information