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

• ClinicalTrials.gov Identifier: NCT02091193
• Recruitment Status: Completed
• First Posted: March 19, 2014
• Last Update Posted: August 10, 2016
• Sponsor: Danbury Hospital
• Collaborator: Prograde Nutrition
• Information provided by (Responsible Party): Joann Petrini, PhD, MPH, Danbury Hospital

Study Description

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).

Condition or disease	Intervention/treatment
Type II Diabetes Mellitus	Dietary Supplement: Krill Oil (Supplement A); Dietary Supplement: Placebo (Supplement B)

Study Design

• Study Type: Observational
• Actual Enrollment: 47 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
• Study Start Date: March 2012
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
Placebo to Krill Oil; Group 2 receives supplement B for four weeks, undergoes a two week washout period, and then receives supplement A for another four weeks. Measurements are taken at baseline, after supplement B completion and after supplement A completion. Participants are informed which supplement was krill oil and which was placebo following completion of this phase of the study. Group 2 participants are given an option to also take an additional 17 weeks of Krill Oil and return for a follow up evaluating the long term use of krill oil.	Dietary Supplement: Krill Oil (Supplement A); Other Name: Prograde, Inc. Krill Oil; Dietary Supplement: Placebo (Supplement B)
Krill Oil to Placebo; Group 1 receives supplement A for four weeks, undergoes a two week washout period, and then receives supplement B for another four weeks. Measurements are taken at baseline, after supplement A completion and after supplement B completion. Participants are informed which supplement was krill oil and which was placebo following completion of this phase of the study. Group 1 participants are given an option to also take an additional 17 weeks of Krill Oil and return for a follow up evaluating the long term use of krill oil.	Dietary Supplement: Krill Oil (Supplement A); Other Name: Prograde, Inc. Krill Oil; Dietary Supplement: Placebo (Supplement B)

Outcome Measures

Primary Outcome Measures :

1. Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo [ Time Frame: Three Months ]

Secondary Outcome Measures :

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 Outcome Measures:

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 ]

Biospecimen Retention:   Samples Without DNA

Only serum is retained and is discarded after specified assays are completed. No analysis requires genetic information.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The groups are selected from primary care offices, a diabetes and endocrine office, as well as self-referrals and medical record confirmed cases of Type 2 Diabetes Mellitus.

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Danbury Hospital

Danbury, Connecticut, United States, 06810

Sponsors and Collaborators

Danbury Hospital

Prograde Nutrition

Investigators

• Principal Investigator: Ramin Ahmadi, MD, MPH; Danbury Hospital

More Information

Additional Information:

Prograde, Inc Krill Oil Information 

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lobraico JM, DiLello LC, Butler AD, Cordisco ME, Petrini JR, Ahmadi R. Effects of krill oil on endothelial function and other cardiovascular risk factors in participants with type 2 diabetes, a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 Oct 14;3(1):e000107. doi: 10.1136/bmjdrc-2015-000107. eCollection 2015.

• Responsible Party: Joann Petrini, PhD, MPH, Director, Clinical and Health Outcomes Research, Danbury Hospital
• ClinicalTrials.gov Identifier: NCT02091193
• Other Study ID Numbers: 12-02-34-334
• First Posted: March 19, 2014
• Last Update Posted: August 10, 2016
• Last Verified: August 2016

Keywords provided by Joann Petrini, PhD, MPH, Danbury Hospital:

Krill Oil; Endothelial Function; Type II Diabetes Mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases