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History of Changes for Study: NCT02091193
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Latest version (submitted August 8, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 17, 2014 None (earliest Version on record)
2 August 8, 2016 Sponsor/Collaborators and Study Status
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Study NCT02091193
Submitted Date:  March 17, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 12-02-34-334
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2014
Overall Status: Completed
Study Start: March 2012
Primary Completion: December 2013 [Actual]
Study Completion: December 2013 [Actual]
First Submitted: March 17, 2014
First Submitted that
Met QC Criteria:
March 17, 2014
First Posted: March 19, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 17, 2014
Last Update Posted: March 19, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Danbury Hospital
Responsible Party: Principal Investigator
Investigator: Ramin Ahmadi
Official Title: Chair of Graduate Medical Education and Research
Affiliation: Danbury Hospital
Collaborators: Prograde Nutrition
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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).

Detailed Description:
Open or close this module Conditions
Conditions: Type II Diabetes Mellitus
Keywords: Krill Oil
Endothelial Function
Type II Diabetes Mellitus
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Only serum is retained and is discarded after specified assays are completed. No analysis requires genetic information.
Enrollment: 47 [Actual]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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 Names:
  • 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 Names:
  • Prograde, Inc. Krill Oil

Dietary Supplement: Placebo (Supplement B)
Open or close this module 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 ]

Open or close this module Eligibility
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.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Ramin Ahmadi, MD, MPH
Principal Investigator
Danbury Hospital
Locations: United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 11861929
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. PubMed 19854375
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. PubMed 15656713
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. PubMed 20121889
Links: Description: Prograde, Inc Krill Oil Information
Available IPD/Information:

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