Cardiovascular DiseasesPhase 1SPIRALNCT04164446
Supplementation of Oil Palm Phenolics to Healthy Participants
A Phase 1 study testing Oil Palm Phenolics in people with Cardiovascular Diseases and Hyperlipidemias, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hyperlipidemias, Hypercholesterolemia
- What is being tested?
- Oil Palm Phenolics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 16 Dec 2019to Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Smoking
- Habitual alcohol consumption
- Consuming antioxidant supplement
- Pregnant/ breastfeeding
- Medical history of cardiovascular disease, diabetes, dyslipidemia
- Current use of antihypertensive or lipid-lowering medication
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
National University of Malaysia
Cheras, WP Kuala Lumpur, 56000
Nurul Izzah Ibrahim, PhD, +60132678770, nurulizzah88@gmail.com
Isa Naina Mohamed, MD, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Placebos, Oil Palm Phenolics
- Keywords
- oil palm phenolics, lipid profile, LDL cholesterol, HDL cholesterol
- Medical subject headings
- Cardiovascular Diseases, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
Also called Placebo
The placebo that will be used contains starch and glucose.
Oil Palm PhenolicsDietary supplement
One capsule contains 250 mg OPP or 1 g OPP
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two capsules containing starch and glucose, once per day, 60 days duration Receives: Drug: Placebos |
| Oil Palm Phenolics 250 mg | Active comparator | One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration Receives: Dietary Supplement: Oil Palm Phenolics |
| Oil Palm Phenolics 1000 mg | Active comparator | One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration Receives: Dietary Supplement: Oil Palm Phenolics |
| Oil Palm Phenolics 2000 mg | Active comparator | Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration Receives: Dietary Supplement: Oil Palm Phenolics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
This will be assessed from the plasma analysis on the fasting blood samples of each participant
Measured: Baseline, day 30, day 60
Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)
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.
Measured: Day 30 after supplementation
Incidence of Adverse Events following two-months supplementation (Safety and Tolerability)
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.
Measured: Day 60 after supplementation
Secondary outcomes (5)
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
This will be assessed from the plasma analysis on the fasting blood samples of each participant.
Measured: Baseline, day 30 and day 60 after supplementation
Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.
This will be assessed from the plasma analysis on the fasting blood samples of each participant.
Measured: 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
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.
Measured: 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
Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant.
Measured: Baseline,day 30 and day 60 after supplementation
Changes from Baseline Body Weight Measurement following one and two months supplementation
This will be assessed by measuring the weight of each participant.
Measured: Baseline,day 30 and day 60 after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start16 Dec 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Principal investigator, Isa Naina Mohamed, National University of Malaysia
- Investigators
- Isa Naina Mohamed, MD, PhD, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164446
- Sponsor's protocol ID
- SPIRAL
- Acronym
- SPIRAL
- Status last verified
- Dec 2019
- First submitted
- 10 Nov 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29844318Muhammad 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.
PubMed 35795564
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Healthy Participants (Phase I Clinical Trial Study)
- ClinicalTrials.gov ID
- NCT04164446
- Acronym / sponsor ID
- SPIRAL / SPIRAL
- Keywords
- oil palm phenolics, lipid profile, LDL cholesterol, HDL cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlacebosTwo capsules containing starch and glucose, once per day, 60 days duration |
| Oil Palm Phenolics 250 mg | Active comparator | Dietary Supplement: Oil Palm PhenolicsOne capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration |
| Oil Palm Phenolics 1000 mg | Active comparator | Dietary Supplement: Oil Palm PhenolicsOne capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration |
| Oil Palm Phenolics 2000 mg | Active comparator | Dietary Supplement: Oil Palm PhenolicsTwo capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Smoking
- Habitual alcohol consumption
- Consuming antioxidant supplement
- Pregnant/ breastfeeding
- Medical history of cardiovascular disease, diabetes, dyslipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebosAlso: PlaceboThe placebo that will be used contains starch and glucose. | Drug | Placebo |
| Oil Palm PhenolicsOne capsule contains 250 mg OPP or 1 g OPP | Dietary supplement | Oil Palm Phenolics 1000 mg, Oil Palm Phenolics 2000 mg, Oil Palm Phenolics 250 mg |
Primary outcome
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
Time frame: Baseline, day 30, day 60
This will be assessed from the plasma analysis on the fasting blood samples of each participant
Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)
Time frame: 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.
Incidence of Adverse Events following two-months supplementation (Safety and Tolerability)
Time frame: 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.
5 secondary outcomes
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
Time frame: Baseline, day 30 and day 60 after supplementation
Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.
Time frame: 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
Time frame: 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
Time frame: Baseline,day 30 and day 60 after supplementation
Changes from Baseline Body Weight Measurement following one and two months supplementation
Time frame: Baseline,day 30 and day 60 after supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Results publication: PubMed 29844318Fairus 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.
- Derived from this study: PubMed 35795564Muhammad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isa Naina Mohamed, MD, PhD principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oil Palm Phenolics in people with Cardiovascular Diseases and Hyperlipidemias, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurul Izzah Ibrahim, PhD (+60132678770, nurulizzah88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation (time frame: Baseline, day 30, day 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164446, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.