Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02091193
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
Prograde Nutrition
Information provided by (Responsible Party):
Joann Petrini, PhD, MPH, Danbury Hospital

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)

Layout table for study information
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

Resource links provided by the National Library of Medicine


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)



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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091193


Locations
Layout table for location information
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Sponsors and Collaborators
Danbury Hospital
Prograde Nutrition
Investigators
Layout table for investigator information
Principal Investigator: Ramin Ahmadi, MD, MPH Danbury Hospital

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Joann Petrini, PhD, MPH, Director, Clinical and Health Outcomes Research, Danbury Hospital
ClinicalTrials.gov Identifier: NCT02091193     History of Changes
Other Study ID Numbers: 12-02-34-334
First Posted: March 19, 2014    Key Record Dates
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:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases