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Supplementation of Oil Palm Phenolics to Healthy Participants (SPIRAL)

20 de diciembre de 2019 actualizado por: Isa Naina Mohamed, National University of Malaysia

Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Healthy Participants (Phase I Clinical Trial Study)

Our previous study has found that oil palm phenolics (OPP) supplementation at 9 grams per day is safe for consumption. An interesting observation was reported where the consumption of OPP showed significantly lower total and LDL cholesterol compared to the control group. There is no clinical evidence as yet on the optimum dosage of OPP supplementation in improving fasting lipid profile. We hypothesize that in a clinical study, OPP supplemented participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability.

Descripción general del estudio

Descripción detallada

During the palm oil milling process, a large amount of vegetation liquor is discarded into the aqueous waste stream. A novel process to recover phenolic compounds from the aqueous waste stream were developed and resulting in producing a filtrate known as oil palm phenolics (OPP), which contains a high amount of phenolic. It has been postulated that phenolic acids components found in the OPP have promising health benefits such as antioxidant, anti-inflammatory, neuroprotective and anti-tumour effects.

Hyperlipidemia, one of the risk factors for cardiovascular diseases (CVD), is defined as elevations of fasting total cholesterol or triglyceride concentration or both. Through our current research, OPP supplementation to hamster animal model has shown positive effects in the reduction of total cholesterol and triglycerides as well as improvement of high-density lipoprotein cholesterol (HDL-C). In a previous study using the rabbit animal model, OPP has shown a protective effect against atherosclerosis, a condition whereby fat and cholesterol plaques are deposited inside the arteries. Based on the current evidence from the preliminary studies on OPP, we hypothesize that supplementation of OPP may prevent or delay the development of CVD.

However, to understand the anti-hyperlipidemic effects of OPP in humans, we need to establish our knowledge of the physiological effects of this compound to normal human subjects. Under physiological condition, OPP may improve the antioxidant and anti-inflammatory status. These improvements may have a positive influence on plasma lipid profile since many scientific evidences demonstrate that antioxidant and anti-inflammatory effects may contribute protection against the incidence of CVD. Therefore, we proposed a clinical trial to evaluate the antioxidant and anti-inflammatory effects of OPP in eliciting the possible mechanism for lipid reduction.

This study will be started with the recruitment of 100 healthy volunteers where they will be supplemented with placebo/OPP capsules at different doses for 60 days. Participants will be required to take the placebo/OPP capsules in front of the study staff to ensure compliance. Blood samples will be withdrawn at baseline, day 30 and day 60, and will be analyzed for lipid profile, antioxidant and anti-inflammatory status. Data from this study would hopefully assist us in understanding the therapeutic roles of OPP on humans under normal conditions.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

100

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • WP Kuala Lumpur
      • Cheras, WP Kuala Lumpur, Malasia, 56000
        • Reclutamiento
        • National University of Malaysia
        • Contacto:
        • Investigador principal:
          • Isa Naina Mohamed, MD, PhD
        • Sub-Investigador:
          • Qodriah Mohd Saad, MBBS, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Healthy
  • Normal Total Cholesterol level of less than 5.2 mmol/dL
  • Normal LDL Cholesterol level of less than 3.36 mmol/dL
  • Normal Triglyceride level of less than 1.69 mmol/dL

Exclusion Criteria:

  • Smoking
  • Habitual alcohol consumption
  • Consuming antioxidant supplement
  • Pregnant/ breastfeeding
  • Medical history of cardiovascular disease, diabetes, dyslipidemia
  • Current use of antihypertensive or lipid-lowering medication

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Two capsules containing starch and glucose, once per day, 60 days duration
The placebo that will be used contains starch and glucose.
Otros nombres:
  • Placebo
Comparador activo: Oil Palm Phenolics 250 mg
One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration
One capsule contains 250 mg OPP or 1 g OPP
Comparador activo: Oil Palm Phenolics 1000 mg
One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration
One capsule contains 250 mg OPP or 1 g OPP
Comparador activo: Oil Palm Phenolics 2000 mg
Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration
One capsule contains 250 mg OPP or 1 g OPP

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
Periodo de tiempo: Baseline, day 30, day 60
This will be assessed from the plasma analysis on the fasting blood samples of each participant
Baseline, day 30, day 60
Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)
Periodo de tiempo: Day 30 after supplementation
This will be assessed via history, physical examination, kidney function test, liver function test and hematology profile from the plasma analysis on the fasting blood samples of each participant.
Day 30 after supplementation
Incidence of Adverse Events following two-months supplementation (Safety and Tolerability)
Periodo de tiempo: Day 60 after supplementation
This will be assessed via history, physical examination, kidney function test, liver function test and hematology profile from the plasma analysis on the fasting blood samples of each participant.
Day 60 after supplementation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
Periodo de tiempo: Baseline, day 30 and day 60 after supplementation
This will be assessed from the plasma analysis on the fasting blood samples of each participant.
Baseline, day 30 and day 60 after supplementation
Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.
Periodo de tiempo: Baseline, day 30 and day 60 after supplementation
This will be assessed from the plasma analysis on the fasting blood samples of each participant.
Baseline, day 30 and day 60 after supplementation
Changes from Baseline Concentrations of Plasma Inflammatory Markers using multiplex assays following one and two months supplementation
Periodo de tiempo: Baseline,day 30 and day 60 after supplementation
Inflammatory markers such as Interleukin-6, Interleukin-1beta, Tumour Necrosis Factor-alpha, Interleukin-10 and interferon-Gamma will be assessed from the plasma analysis on the fasting blood samples of each participant.
Baseline,day 30 and day 60 after supplementation
Changes from Baseline Concentrations of Plasma Antioxidant Levels using ELISA method following one and two months supplementation
Periodo de tiempo: Baseline,day 30 and day 60 after supplementation
Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant.
Baseline,day 30 and day 60 after supplementation
Changes from Baseline Body Weight Measurement following one and two months supplementation
Periodo de tiempo: Baseline,day 30 and day 60 after supplementation
This will be assessed by measuring the weight of each participant.
Baseline,day 30 and day 60 after supplementation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Isa Naina Mohamed, MD, PhD, National University of Malaysia

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de diciembre de 2019

Finalización primaria (Anticipado)

1 de abril de 2020

Finalización del estudio (Anticipado)

1 de abril de 2020

Fechas de registro del estudio

Enviado por primera vez

10 de noviembre de 2019

Primero enviado que cumplió con los criterios de control de calidad

14 de noviembre de 2019

Publicado por primera vez (Actual)

15 de noviembre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de diciembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

20 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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