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

Tracking Information

• First Submitted Date: March 17, 2014
• First Posted Date: March 19, 2014
• Last Update Posted Date: August 10, 2016
• Study Start Date: March 2012
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 17, 2014): Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo [ Time Frame: Three Months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 17, 2014): Change in Lipid Profile (HDL, LDL, Total Cholesterol), Glucose, Hemoglobin A1C with Krill Oil Supplementation Compared with Baseline and Placebo [ Time Frame: Three months ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 17, 2014)

• Change C-Peptide and Total Antioxidant Capacity of Serum Compared with Baseline and Placebo [ Time Frame: Three 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. [ Time Frame: 17 weeks ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
• Official Title: Effects of Krill Oil on Endothelial Function in Patients With Type 2 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).

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

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

• 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.
• Condition: Type II Diabetes Mellitus

Intervention

• Dietary Supplement: Krill Oil (Supplement A)
  Other Name: Prograde, Inc. Krill Oil
• Dietary Supplement: Placebo (Supplement B)

Study Groups/Cohorts

• 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.
  Interventions:

  • Dietary Supplement: Krill Oil (Supplement A)
  • 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.
  Interventions:

  • Dietary Supplement: Krill Oil (Supplement A)
  • Dietary Supplement: Placebo (Supplement B)

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. doi: 10.1203/00006450-200203000-00002.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 17, 2014): 47
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02091193
• Other Study ID Numbers: 12-02-34-334
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joann Petrini, PhD, MPH, Danbury Hospital
• Original Responsible Party: Ramin Ahmadi, Danbury Hospital, Chair of Graduate Medical Education and Research
• Current Study Sponsor: Danbury Hospital
• Original Study Sponsor: Same as current
• Collaborators: Prograde Nutrition

Investigators

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

• PRS Account: Danbury Hospital
• Verification Date: August 2016