Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Background:
Fish oils contain omega-3 fatty acids that play important roles in the body. Researchers are studying a new type of fish oil that contains very-long-chain omega-3 fatty acids (VLCPUFAs). They want to learn how this fish oil affects omega-3 levels in the blood and other measures related to health.
Objective:
To learn how a VLCPUFA-enriched fish oil changes omega-3 levels in the blood compared with a standard fish oil.
Eligibility:
Healthy adults ages 18 to 60 years with a body mass index (BMI) between 18 and 30 kg/m^2 may be eligible.
Design:
Participants will take part in the study for about 28 to 30 weeks and will have approximately 4 to 5 clinic visits plus a follow-up phone call.
Participants will complete screening tests to determine whether they are eligible. These may include a physical examination, blood tests, measurement of height and weight, visual testing, cognitive testing, and questions about their diet, exercise, medications, and daily habits.
Participants will take 2 fish oil capsules by mouth every day for 8 weeks. They will then stop taking study capsules for about 12 weeks. After that, they will take a different fish oil capsule for another 8 weeks.
One fish oil contains very-long-chain omega-3 fatty acids (VLCPUFAs), and the other contains standard omega-3 fatty acids. Participants will not know which type they are taking during each study period.
Blood samples and other study assessments will be collected at the beginning and end of each treatment period to measure changes in omega-3 levels and other study markers.
Participants will receive a follow-up phone call about one week after taking their last dose of study supplement.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Study Description:
This study is designed to investigate changes in the omega-3 index (ratio of omega-3 fatty acids (eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)) over total RBC fatty acids) following supplementation with a fish oil enriched in very long chain polyunsaturated fatty acids (VLCPUFA) versus a standard, commercially available, over-the-counter (OTC), fish oil enriched in DHA. VLCPUFA-enriched fish oil provides roughly 10-fold the amount of VLCPUFA found in conventional fish oils. The oil was developed as a dietary supplement by Epax Norway AS. It may offer several potential advantages over standard fish oils in the improvement of risk factors for age-related macular degeneration (AMD) and cardiovascular disease (CVD) because of its higher content of VLCPUFAs. The study is designed as a double-blinded, randomized crossover study measuring differences in the omega-3 index following fish oil supplementation in healthy subjects.
Objectives:
Primary Objective: Compare the Omega-3 index score of participants given a DHA-rich fish oil versus those given VLCPUFA-rich fish oil.
Secondary Objective: Evaluate changes of biomarkers related to lipoprotein metabolism for VLCPUFA-rich fish oil.
Exploratory Objective:
- Evaluate changes in clinical markers of cardiometabolic health, neurocognition and visual acuity with the VLCPUFA-rich fish oil.
- Characterize the early absorption profile and interindividual variability of VLCPUFA-rich fish oil under standardized fasting conditions following a single oral dose in participants who elect to complete the optional overnight Metabolic Unit visit.
Endpoints:
Primary Endpoint: Changes in patient Omega-3 index in participants given DHA-rich fish oil (control) versus those given VLCPUFA-rich fish oil.
Secondary Endpoint: Changes in standard lipid panel and Nuclear Magnetic Resonance (NMR) lipoprotein profile in participants given DHA-rich fish oil versus those given VLCPUFA-rich fish oil.
Exploratory Endpoints:
- Changes from baseline markers of glucose, fatty acid (FA) metabolism, red blood cell fatty acid profile, inflammation and coagulation in participants given a DHA-rich fish oil versus those given VLCPUFA-rich fish oil.
- Evaluate changes in neurocognitive tests and visual acuity tests from baseline in participants given a DHA-rich fish oil versus those given VLCPUFA-rich fish oil.
- Baseline-adjusted changes in plasma fatty acid concentrations (including VLCPUFAs and related omega-3 fatty acids) over the first approximately 2 hours following administration of the study product during the optional overnight Metabolic Unit visit.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joy Lynne V Freeman
- Numéro de téléphone: (301) 480-7632
- E-mail: joylynne.freeman@nih.gov
Sauvegarde des contacts de l'étude
- Nom: Marcelo J Amar, M.D.
- Numéro de téléphone: (301) 402-0521
- E-mail: mamar@mail.nih.gov
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- Recrutement
- National Institutes of Health Clinical Center
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Contact:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Numéro de téléphone: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
- INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all the following criteria:
-
Male or female, age 18-60 years, in good general health in accordance with PI evaluation.
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Body Mass Index (BMI) >18 and <30 kg/m^2.
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Ability to take oral medication.
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Participant demonstrates willingness to sign the informed consent form, comply with all study procedures.
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For females of childbearing potential, stated willingness to use an accepted method of contraception for the duration of the study. Accepted methods of contraception are:
- Contraceptive implant
- Intrauterine device (hormonal or copper IUD)
- Permanent procedures: vasectomy, bilateral salpingectomy, or tubal occlusion
- Oral contraceptives (the pill)
- Contraceptive patch
- Contraceptive vaginal ring
- Injectable contraceptives
- Male or female condoms (typically as a secondary method)
- Diaphragm or cervical cap
- Sterilization (of either partner)
- Previously documented menopause for women as applicable
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Screening labs within normal levels. Minor deviations from the normal screening labs are allowed per PI discretion.
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
- Current or recent (2 months or less) use of omega-3 fatty acid supplements or foods enriched with omega-3 fatty acids (no more than two servings of fish per week), bile-acid sequestrants, plant sterol supplements, anticoagulants, fibrates, Niacin, or daily use of NSAIDs or medication that can affect lipid metabolism or any endpoint of the study (to be reviewed by the PI).
- Subjects who have started or stopped medications that did not reach a stable baseline; subjects taking chronic medications or supplements.
- Pregnancy (or planned pregnancy) or lactation.
- Subjects planning a significant change in diet or exercise levels.
- Known allergic reactions to fish or shellfish or omega-3 fatty acids supplements, and subjects with bleeding disorders.
- Current use of anticoagulant or antiplatelet drugs.
- History of heavy menstruation, chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or presence of other conditions that could affect intestinal fat absorption.
- Acute and life-threatening conditions, such as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism.
- Subject with known history of Atrial Fibrillation.
- Anticipated surgery during the study period.
- Previous blood donation within 3 months of the start of the study.
- Any other reason or clinical condition that the PI judges would interfere with study participation and/or be unsafe for a participant.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: DHA-rich Fish Oil VLCPUFA-rich Fish Oil
Participants receive DHA-rich fish oil during the first intervention period, followed by VLCPUFA-rich fish oil during the second intervention period, according to the study crossover design. |
Fish oil enriched in very-long-chain polyunsaturated fatty acids (VLCPUFAs), developed by Epax Norway AS. Standard commercially available over-the-counter fish oil enriched in docosahexaenoic acid (DHA), used as the comparator. In this randomized crossover study, participants receive both the DHA-rich fish oil and the VLCPUFA-rich fish oil in a randomized sequence. |
|
Expérimental: VLCPUFA-rich Fish Oil DHA-rich Fish Oil
Participants receive VLCPUFA-rich fish oil during the first intervention period, followed by DHA-rich fish oil during the second intervention period, according to the study crossover design. |
Fish oil enriched in very-long-chain polyunsaturated fatty acids (VLCPUFAs), developed by Epax Norway AS. Standard commercially available over-the-counter fish oil enriched in docosahexaenoic acid (DHA), used as the comparator. In this randomized crossover study, participants receive both the DHA-rich fish oil and the VLCPUFA-rich fish oil in a randomized sequence. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Omega-3 Index
Délai: Baseline and after each 8-week intervention period
|
Change in the Omega-3 Index, defined as the percentage of EPA plus DHA relative to total red blood cell fatty acids, following supplementation with VLCPUFA-rich fish oil compared with control fish oil. |
Baseline and after each 8-week intervention period
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Marcelo J Amar, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 10002202
- 002202-H
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
All IPD that underlie results in a publication
Délai de partage IPD
3-6 months after the publication
Critères d'accès au partage IPD
Data for this study will be shared in open access repositories
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
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