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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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Joann Petrini, PhD, MPH, Danbury Hospital
Study Sponsor Danbury Hospital
Collaborators Prograde Nutrition
Investigators
Principal Investigator: Ramin Ahmadi, MD, MPH Danbury Hospital
PRS Account Danbury Hospital
Verification Date August 2016