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Supplementation of Oil Palm Phenolics to Healthy Participants (SPIRAL)
Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Healthy Participants (Phase I Clinical Trial Study)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Nurul Izzah Ibrahim, PhD
- Número de telefone: +60132678770
- E-mail: nurulizzah88@gmail.com
Estude backup de contato
- Nome: Isa Naina Mohamed, MD, PhD
- Número de telefone: +60391459568
- E-mail: isanaina@ppukm.edu.my
Locais de estudo
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WP Kuala Lumpur
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Cheras, WP Kuala Lumpur, Malásia, 56000
- Recrutamento
- National University of Malaysia
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Contato:
- Nurul Izzah Ibrahim, PhD
- Número de telefone: +60132678770
- E-mail: nurulizzah88@gmail.com
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Investigador principal:
- Isa Naina Mohamed, MD, PhD
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Subinvestigador:
- Qodriah Mohd Saad, MBBS, PhD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador de Placebo: Placebo
Two capsules containing starch and glucose, once per day, 60 days duration
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The placebo that will be used contains starch and glucose.
Outros nomes:
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Comparador Ativo: 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
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One capsule contains 250 mg OPP or 1 g OPP
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Comparador Ativo: 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
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One capsule contains 250 mg OPP or 1 g OPP
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Comparador Ativo: Oil Palm Phenolics 2000 mg
Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration
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One capsule contains 250 mg OPP or 1 g OPP
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
Prazo: Baseline, day 30, day 60
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This will be assessed from the plasma analysis on the fasting blood samples of each participant
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Baseline, day 30, day 60
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Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)
Prazo: Day 30 after supplementation
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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.
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Day 30 after supplementation
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Incidence of Adverse Events following two-months supplementation (Safety and Tolerability)
Prazo: Day 60 after supplementation
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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.
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Day 60 after supplementation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
Prazo: Baseline, day 30 and day 60 after supplementation
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This will be assessed from the plasma analysis on the fasting blood samples of each participant.
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Baseline, day 30 and day 60 after supplementation
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Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.
Prazo: Baseline, day 30 and day 60 after supplementation
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This will be assessed from the plasma analysis on the fasting blood samples of each participant.
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Baseline, day 30 and day 60 after supplementation
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Changes from Baseline Concentrations of Plasma Inflammatory Markers using multiplex assays following one and two months supplementation
Prazo: Baseline,day 30 and day 60 after supplementation
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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.
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Baseline,day 30 and day 60 after supplementation
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Changes from Baseline Concentrations of Plasma Antioxidant Levels using ELISA method following one and two months supplementation
Prazo: Baseline,day 30 and day 60 after supplementation
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Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant.
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Baseline,day 30 and day 60 after supplementation
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Changes from Baseline Body Weight Measurement following one and two months supplementation
Prazo: Baseline,day 30 and day 60 after supplementation
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This will be assessed by measuring the weight of each participant.
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Baseline,day 30 and day 60 after supplementation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Isa Naina Mohamed, MD, PhD, National University of Malaysia
Publicações e links úteis
Publicações Gerais
- Fairus S, Leow SS, Mohamed IN, Tan YA, Sundram K, Sambanthamurthi R. A phase I single-blind clinical trial to evaluate the safety of oil palm phenolics (OPP) supplementation in healthy volunteers. Sci Rep. 2018 May 29;8(1):8217. doi: 10.1038/s41598-018-26384-7.
- Muhammad Ismail Tadj NB, Ibrahim N', Haji Mohd Saad Q, Tg Abu Bakar Sidik TMI, Leow SS, Fairus S, Naina Mohamed I. A Phase I, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Tolerance of Oil Palm Phenolics (OPP) in Healthy Volunteers. Front Pharmacol. 2022 Jun 20;13:893171. doi: 10.3389/fphar.2022.893171. eCollection 2022.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SPIRAL
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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