Hypertriglyceridemia
Conditions
Keywords
Active-placebo controlled double blind cross over
Brief summary
The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.
Detailed description
The objective of this study is to evaluate and compare the acute and sub-chronic (2 week) bioavailability of EPA and DHA from two marine oil supplements consumed with a meal in men and women with mildly elevated triglycerides. The supplements provide similar amounts of EPA + DHA esterified as either triglycerides; or esterified as phospholipids and triglycerides.
Interventions
DIETARY_SUPPLEMENTDHA-rich fish oil versus Phospholipid-rich fish oil
This randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5.
Sponsors
BioFortis
University of British Columbia
Arctic Nutrition AS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is male or female, 18-59 years of age, inclusive. 2. Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7). 3. Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3). 4. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results. 5. Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL. 6. Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1). 7. Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study. 8. Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits \[visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h\]. 9. Subject is willing to comply with fecal collection procedures. 10. Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial. 11. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion criteria
1. Subject is male or female, 18-59 years of age, inclusive. 2. Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7). 3. Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3). 4. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results. 5. Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL. 6. Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1). 7. Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study. 8. Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits \[visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h\]. 9. Subject is willing to comply with fecal collection procedures. 10. Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial. 11. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve for plasma phosphatidylcholine omega-3 fatty acids | pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose | The primary outcome variable will be the net incremental area under the curve (niAUC) for plasma phosphatidylcholine (PC) EPA + DHA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC 0-12 h post-dose) measured at visits 2 and 4 (analyzed with and without normalization to the intake of EPA+DHA in each group). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids | pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose | The maximal concentration (Cmax) and time to Cmax (Tmax) for plasma PC EPA + DHA, EPA, DHA, DPA, and EPA + DHA + DPA (analyzed with and without normalization to the intake of EPA, DHA, DPA, and EPA+DHA+DPA in each group) from pre-meal to 12 h post-dose at visits 2 and 4. |
| Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2 | pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose | The niAUC for plasma PC EPA; PC DHA; PC DPA; PC EPA + DHA + DPA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC0-12 h) at visits 2 and 4 (analyzed with and without normalization to the intake of EPA, DHA, DPA, and EPA+DHA+DPA in each group). |
| Plasma sphingomyelin and total plasma phosphatidylcholine | pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose | Plasma sphingomyelin and total plasma PC at visits 2, 3, 4, and 5 |
| Adverse Events (AE) | pre-treatment, 0, 12 hours post-dose | AE assessed at each visit |
| Gastrointestinal (GI) Tolerability Questionnaire | 0, 12 hours post-dose | Ratings from the GI Tolerability Questionnaire |
| Product Acceptability Questionnaire | 0, 12 hours post-dose | Ratings from the Product Acceptability Questionnaire |
| Fasting plasma lipoprotein lipids | pre-dose | Percent changes from baseline (average of values at visits 1 and 2) to the end of each treatment period (visits 3,4,5) in the following fasting lipoprotein lipids: high-density lipoprotein cholesterol (HDL-C), non-HDL-C, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides, and high sensitivity C reactive protein (hs-CRP). |
Countries
United States
Contacts
Primary ContactKristen Sanoshy, MPH, RHIA
Backup ContactPam Coleman, MBA, CFS
Outcome results
None listed