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Supplementation of Oil Palm Phenolics to Healthy Participants (SPIRAL)

20 december 2019 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

100

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Malaysia
    • WP Kuala Lumpur
      • Cheras, WP Kuala Lumpur, Malaysia, 56000
        • Rekrytering
        • National University of Malaysia
        • Kontakt:
        • Huvudutredare:
          • Isa Naina Mohamed, MD, PhD
        • Underutredare:
          • Qodriah Mohd Saad, MBBS, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 40 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Two capsules containing starch and glucose, once per day, 60 days duration
Läkemedel: Placebos
The placebo that will be used contains starch and glucose.
Andra namn:
  • Placebo
Aktiv komparator: 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
Kosttillskott: Oil Palm Phenolics
One capsule contains 250 mg OPP or 1 g OPP
Aktiv komparator: 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
Kosttillskott: Oil Palm Phenolics
One capsule contains 250 mg OPP or 1 g OPP
Aktiv komparator: Oil Palm Phenolics 2000 mg
Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration
Kosttillskott: Oil Palm Phenolics
One capsule contains 250 mg OPP or 1 g OPP

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National University of Malaysia

Samarbetspartners

Malaysia Palm Oil Board

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 december 2019

Primärt slutförande (Förväntat)

1 april 2020

Avslutad studie (Förväntat)

1 april 2020

Studieregistreringsdatum

Först inskickad

10 november 2019

Först inskickad som uppfyllde QC-kriterierna

14 november 2019

Första postat (Faktisk)

15 november 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 december 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 december 2019

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SPIRAL

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