Supplementation of Oil Palm Phenolics to Healthy Participants

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

Patrocinadores

Patrocinador principal: National University of Malaysia

Colaborador: Malaysia Palm Oil Board

Fuente National University of Malaysia
Resumen breve

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 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.

Estado general Recruiting
Fecha de inicio December 16, 2019
Fecha de Terminación April 2020
Fecha de finalización primaria April 2020
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation Baseline, day 30, day 60
Incidence of Adverse Events following one-month supplementation (Safety and Tolerability) Day 30 after supplementation
Incidence of Adverse Events following two-months supplementation (Safety and Tolerability) Day 60 after supplementation
Resultado secundario
Medida Periodo de tiempo
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation Baseline, day 30 and day 60 after supplementation
Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation. 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 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 Baseline,day 30 and day 60 after supplementation
Changes from Baseline Body Weight Measurement following one and two months supplementation Baseline,day 30 and day 60 after supplementation
Inscripción 100
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Placebos

Descripción: The placebo that will be used contains starch and glucose.

Etiqueta de grupo de brazo: Placebo

Otro nombre: Placebo

Tipo de intervención: Dietary Supplement

Nombre de intervención: Oil Palm Phenolics

Descripción: One capsule contains 250 mg OPP or 1 g OPP

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 20 Years

Edad máxima: 40 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Isa Naina Mohamed, MD, PhD Principal Investigator National University of Malaysia
Contacto general

Apellido: Nurul Izzah Ibrahim, PhD

Teléfono: +60132678770

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador: National University of Malaysia Nurul Izzah Ibrahim, PhD +60132678770 [email protected] Isa Naina Mohamed, MD, PhD Principal Investigator Qodriah Mohd Saad, MBBS, PhD Sub-Investigator
Ubicacion Paises

Malaysia

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: National University of Malaysia

Nombre completo del investigador: Isa Naina Mohamed

Título del investigador: Associate Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Two capsules containing starch and glucose, once per day, 60 days duration

Etiqueta: Oil Palm Phenolics 250 mg

Tipo: Active Comparator

Descripción: One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration

Etiqueta: Oil Palm Phenolics 1000 mg

Tipo: Active Comparator

Descripción: One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration

Etiqueta: Oil Palm Phenolics 2000 mg

Tipo: Active Comparator

Descripción: Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration

Acrónimo SPIRAL
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Prevention

Enmascaramiento: Triple (Participant, Care Provider, Investigator)

Fuente: ClinicalTrials.gov