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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joy Lynne V Freeman
- Número de teléfono: (301) 480-7632
- Correo electrónico: joylynne.freeman@nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Marcelo J Amar, M.D.
- Número de teléfono: (301) 402-0521
- Correo electrónico: mamar@mail.nih.gov
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- Reclutamiento
- National Institutes of Health Clinical Center
-
Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 800-411-1222
- Correo electrónico: ccopr@nih.gov
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- 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.
-
Body Mass Index (BMI) >18 and <30 kg/m^2.
-
Ability to take oral medication.
-
Participant demonstrates willingness to sign the informed consent form, comply with all study procedures.
-
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
-
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Omega-3 Index
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marcelo J Amar, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 10002202
- 002202-H
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All IPD that underlie results in a publication
Marco de tiempo para compartir IPD
3-6 months after the publication
Criterios de acceso compartido de IPD
Data for this study will be shared in open access repositories
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .