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)
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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 Blood samples will be withdrawn at baseline, day 30 and day 60, and will be analyzed for lipid profile, antioxidant and anti-inflammatory status.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.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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WP Kuala Lumpur
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Cheras, WP Kuala Lumpur, Malajsie, 56000
- Nábor
- National University of Malaysia
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Kontakt:
- Nurul Izzah Ibrahim, PhD
- Telefonní číslo: +60132678770
- E-mail: nurulizzah88@gmail.com
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Vrchní vyšetřovatel:
- Isa Naina Mohamed, MD, PhD
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Dílčí vyšetřovatel:
- Qodriah Mohd Saad, MBBS, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: 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.
Ostatní jména:
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Aktivní komparátor: 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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Aktivní komparátor: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Isa Naina Mohamed, MD, PhD, National University of Malaysia
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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