Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women

Completed · Not applicable

Conditions studied: Healthy

In brief

The objective of this study was to evaluate and compare the acute bioavailability of EPA and DHA in wax ester form provided as a dietary supplement compared to a well-studied and defined ethyl ester formulation in generally healthy men and women.

Key facts

Study ID

NCT02865044

Run by

Calanus

People needed

18

Starts

2015-03-01

Expected to finish

2015-04-01

Last updated by the study team

2016-08-12

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, 18-59 years of age, inclusive.
• BMI of ≥18.50 and ≤29.99 kg/m2 at visit 1 (day -7).
• Fasting TG <200 mg/dL at visit 1 (day -7).
• Score of 7 to 10 on the Vein Access Scale at visit 1 (day -7).
• No health conditions that would prevent the subject from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
• Willing to refrain from consumption of all fish/seafood (including shellfish), and/or EPA- or DHA-containing foods and supplements 14 d prior to visit 2 (day 0) and throughout the study.
• Willing to limit alcohol consumption to no more than 1 drink/d following visit 1 (day -7) and throughout the study.
• Non-smoker with no plans to change smoking habits during the study period.
• Willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
• Understood the study procedures and signed forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the study Investigator.

You may not qualify if…

• Abnormal laboratory test results of clinical significance at visit 1 (day -7), at the discretion of the Investigator. One re-test was allowed on a separate day prior to visit 2 (day 0) for subjects with abnormal laboratory test results.
• History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders.
• History or presence of a GI disorder that, in the judgment of the Investigator, may have disrupted normal digestion and absorption of the study products.
• History of difficulty swallowing tablets/capsules that could have affected ability to consume the study products.
• Extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at visit 1 (day -7). One re-test was allowed on a separate day prior to visit 2 (day 0), for subjects whose blood pressure exceeded either of these cut points, in the judgment of the Investigator.
• History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Weight loss or gain >4.5 kg in the 3 months prior to visit 1 (day -7).
• Use of medications or dietary supplements known to alter lipid concentrations within 4 weeks of visit 1 (day -7). Dietary supplements included, but were not limited to, the following: sterol/stanol products; dietary fiber supplements (including >1 teaspoon Metamucil® or viscous fiber-containing supplement per day); red rice yeast supplements; garlic supplements; soy isoflavone supplements; or niacin or its analogues at dosages >50 mg/day (or others at the discretion of the Investigator).
• Use of non-study related omega-3-acid ethyl ester drug(s) or dietary supplement(s) with ≥1.0 g/d of EPA, DHA, or a combination of EPA and DHA within 4 months of visit 1 (day -7).
• Known allergy or sensitivity to omega-3 fatty acids, fish, other seafood, or any ingredient in the study product or study meals.
• Active infection or use of antibiotics within 5 d of visits 2 and 6 (days 0 and 14). Subjects that had an active infection and/or were using antibiotics were required to wait at least 5 d after the infection resolved or antibiotic use was complete prior to the first day of each test period (visits 2 and 6, days 0 and 14).
• Female who was pregnant, planning to be pregnant during the study period, lactating, or was of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception was recorded in the source documentation.
• Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).
• Recent history of (within 12 months of screening; visit 1, day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).

Where it is running

• Biofortis Clinical Research — Addison, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.