Supplementation of Oil Palm Phenolics to Healthy Participants
Klíčová slova
Abstraktní
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 Blood samples will be withdrawn at baseline, day 30 and day 60, and will be analyzed for lipid profile, antioxidant and anti-inflammatory status.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.
Termíny
| Poslední ověření: | 11/30/2019 |
| První předloženo: | 11/09/2019 |
| Odhadovaná registrace vložena: | 11/13/2019 |
| První zveřejnění: | 11/14/2019 |
| Poslední aktualizace byla odeslána: | 12/19/2019 |
| Poslední aktualizace zveřejněna: | 12/22/2019 |
| Aktuální datum zahájení studie: | 12/15/2019 |
| Odhadované datum dokončení primární: | 03/31/2020 |
| Odhadované datum dokončení studie: | 03/31/2020 |
Stav nebo nemoc
Intervence / léčba
Drug: Placebo
Dietary Supplement: Oil Palm Phenolics
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Placebo Comparator: Placebo Two capsules containing starch and glucose, once per day, 60 days duration | Drug: Placebo The placebo that will be used contains starch and glucose. |
| Active Comparator: 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 | |
| Active Comparator: 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 | |
| Active Comparator: Oil Palm Phenolics 2000 mg Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 20 Years Na 20 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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 |
Výsledek
Primární výsledná opatření
1. Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation [Baseline, day 30, day 60]
2. Incidence of Adverse Events following one-month supplementation (Safety and Tolerability) [Day 30 after supplementation]
3. Incidence of Adverse Events following two-months supplementation (Safety and Tolerability) [Day 60 after supplementation]
Měření sekundárních výsledků
1. 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]
2. Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation. [Baseline, day 30 and day 60 after supplementation]
3. 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]
4. 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]
5. Changes from Baseline Body Weight Measurement following one and two months supplementation [Baseline,day 30 and day 60 after supplementation]
