HyperlipidemiasPhase 2NCT04573218
Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia
A Phase 2 study testing 250 mg OPP in people with Hyperlipidemias and Hypercholesterolemia, run by Isa Naina Mohamed at 1 site in Malaysia.
Trial summary
An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate the ability to lower total and LDL cholesterol. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Hypercholesterolemia
- What is being tested?
- 250 mg OPP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Oct 2021to 20 Dec 2021
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elevated Fasting Total cholesterol level of more than 5.2 mmol/L
- Elevated Fasting LDL cholesterol of more than 3.36 mmol/L*
- Elevated Fasting Triglycerides of more than 1.69 mmol/L*
- Willing to remain staying in Klang Valley area in the case of Movement Control Order implementation.
Who cannot join
- Elevated Total cholesterol level of more than 6.2 mmol/L
- Elevated LDL cholesterol of more than 4.9 mmol/L
- Elevated Triglycerides of more than 5.6 mmol/L
- Smoking
- Habitual alcohol consumption
- Consuming antioxidant supplement
Show all 9Show fewer
- Pregnant/ breastfeeding
- Medical history of cardiovascular disease, diabetes, dyslipidemia, familial hyperlipidemia, hypothyroidism, kidney disease and endocrine disease.
- Current use of lipid-lowering medication
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National University of Malaysia
Cheras, WP Kuala Lumpur, 56000
About this study
Official title: Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study)
An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate the ability to lower total and LDL cholesterol. There is no clinical evidence as yet on that optimum dosage of OPP supplementation in improving fasting lipid profile in minor hyperlipidemia subjects. The investigators hypothesize that in a clinical study, OPP supplemented to the minor hyperlipidemic participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability. OPP may have the potential to be positioned as natural health supplement in improving lipid profile.
Read the detailed description
Oil palm phenolics (OPP) is a product filtrated from vegetation liquor of an aqueous waste stream following palm oil milling process. A novel process to recover OPP that contains a high amount of phenolic from the waste has been explored tremendously. Due to the high phenolic content, OPP has been postulated in possessing various medicinal properties such as antioxidant, anti-inflammatory, neuroprotective and anti-tumour effects.
Hyperlipidemia is a well-known risk factor for cardiovascular diseases (CVD). It can be defined as elevations of fasting total cholesterol or triglyceride concentration or both. According to a previous 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, the investigators hypothesize that supplementation of OPP may prevent or delay the development of CVD.
In the investigator's previous clinical trial phase I, an optimum dosage of OPP has been obtained. Therefore, the investigators proposed a phase II clinical trial to evaluate the ability of OPP to reduce the total and LDL cholesterol in minor hyperlipidemic participants.
This study will be initiated with the recruitment of 50 volunteers with minor hyperlipidemic condition. In this study, the participants will be supplemented with placebo/OPP capsules 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 the investigator in understanding the therapeutic roles of OPP in humans under minor hyperlipidemic conditions.
- Conditions
- Hyperlipidemias, Hypercholesterolemia
- Being tested
- Placebo, 250 mg OPP
- Keywords
- oil palm phenolics, lipid profile
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The placebo contains glucose
250 mg OPPDietary supplement
250 mg Oil Palm Phenolics
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Glucose. Receives: Drug: Placebo |
| Group B | Active comparator | 250 mg Oil Palm Phenolics. Receives: Dietary Supplement: 250 mg OPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of fasting plasma LDL cholesterol levels
This will be assessed from the Fasting Plasma LDL Cholesterol level of each participant following one month and two months supplementation.
Measured: Baseline, day 30, day 60 after supplementation
Secondary outcomes (8)
Changes of Fasting lipid profile (total cholesterol)
This will be assessed from the Fasting Plasma Total Cholesterol level of each participant following one month and two months supplementation
Measured: Baseline, day 30 and day 60 after supplementation
Changes of Fasting lipid profile (HDL cholesterol)
This will be assessed from the Fasting Plasma HDL Cholesterol level of each participant following one month and two months supplementation
Measured: Baseline,day 30 and day 60 after supplementation
Changes of Fasting lipid profile (Triglyceride)
This will be assessed from the Fasting Plasma Triglyceride level of each participant following one month and two months supplementation
Measured: Baseline,day 30 and day 60 after supplementation
Changes of plasma inflammatory markers
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 following one and two months of supplementation. The measurement of the plasma inflammatory markers will be performed by Multiplex assay method.
Measured: Baseline, day 30 and day 60 after supplementation
Changes of Plasma Antioxidant Levels
Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant following one and two months of supplementation. The measurement of the antioxidant levels will be performed by Using ELISA Method.
Measured: Baseline, day 30 and day 60 after supplementation
Incidence of adverse events via evaluation of renal function test
This will be assessed by Kidney Function test from the fasting plasma analysis of each participant following one month and two months supplementation
Measured: Baseline, day 30 and day 60 after supplementation
Incidence of adverse events via evaluation of liver function test
This will be assessed by Liver Function Test from the fasting plasma analysis of each participants following one-month and two-months supplementation
Measured: Baseline, day 30 and day 60 after supplementation
Changes of Body weight measurement
This will be assessed by measuring the weight of each participant. Any drastic change in body weight will indicate non-compliance.
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 posted5 Oct 2020
- Study start18 Oct 2021
- Primary completion16 Dec 2021
- Study completion20 Dec 2021
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 HyperlipidemiasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isa Naina Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Sponsor-investigator, Isa Naina Mohamed, National University of Malaysia
- Investigators
- Isa Naina Mohamed, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573218
- Sponsor's protocol ID
- SAPPHIRE
- Status last verified
- Apr 2022
- First submitted
- 28 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 NI, Tg Abu Bakar Sidik TMI, Zulfarina MS, Haji Mohd Saad Q, Leow SS, Fairus S, Naina Mohamed I. Safety and efficacy of oil palm phenolic supplementation in improving lipid profile among hyperlipidemic adults: a phase 2, randomized, double-blind, placebo-controlled clinical trial. Front Pharmacol. 2023 Jul 7;14:1190663. doi: 10.3389/fphar.2023.1190663. eCollection 2023.
PubMed 37484009
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. 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 Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study)
- ClinicalTrials.gov ID
- NCT04573218
- Acronym / sponsor ID
- SAPPHIRE
- Conditions
- Hyperlipidemias, Hypercholesterolemia
- Keywords
- oil palm phenolics, lipid profile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Isa Naina MohamedUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 5 Oct 2020 (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.
An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate the ability to lower total and LDL cholesterol. There is no clinical evidence as yet on that optimum dosage of OPP supplementation in improving fasting lipid profile in minor hyperlipidemia subjects. The investigators hypothesize that in a clinical study, OPP supplemented to the minor hyperlipidemic participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability. OPP may have the potential to be positioned as natural health supplement in improving lipid profile.
Detailed description
Oil palm phenolics (OPP) is a product filtrated from vegetation liquor of an aqueous waste stream following palm oil milling process. A novel process to recover OPP that contains a high amount of phenolic from the waste has been explored tremendously. Due to the high phenolic content, OPP has been postulated in possessing various medicinal properties such as antioxidant, anti-inflammatory, neuroprotective and anti-tumour effects.
Hyperlipidemia is a well-known risk factor for cardiovascular diseases (CVD). It can be defined as elevations of fasting total cholesterol or triglyceride concentration or both. According to a previous 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, the investigators hypothesize that supplementation of OPP may prevent or delay the development of CVD.
In the investigator's previous clinical trial phase I, an optimum dosage of OPP has been obtained. Therefore, the investigators proposed a phase II clinical trial to evaluate the ability of OPP to reduce the total and LDL cholesterol in minor hyperlipidemic participants.
This study will be initiated with the recruitment of 50 volunteers with minor hyperlipidemic condition. In this study, the participants will be supplemented with placebo/OPP capsules 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 the investigator in understanding the therapeutic roles of OPP in humans under minor hyperlipidemic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: PlaceboGlucose. |
| Group B | Active comparator | Dietary Supplement: 250 mg OPP250 mg Oil Palm Phenolics. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elevated Fasting Total cholesterol level of more than 5.2 mmol/L
- Elevated Fasting LDL cholesterol of more than 3.36 mmol/L*
- Elevated Fasting Triglycerides of more than 1.69 mmol/L*
- Willing to remain staying in Klang Valley area in the case of Movement Control Order implementation.
Key exclusion criteria (9 listed)
- Elevated Total cholesterol level of more than 6.2 mmol/L
- Elevated LDL cholesterol of more than 4.9 mmol/L
- Elevated Triglycerides of more than 5.6 mmol/L
- Smoking
- Habitual alcohol consumption
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 |
|---|---|---|
| PlaceboThe placebo contains glucose | Drug | Group A |
| 250 mg OPP250 mg Oil Palm Phenolics | Dietary supplement | Group B |
Primary outcome
Changes of fasting plasma LDL cholesterol levels
Time frame: Baseline, day 30, day 60 after supplementation
This will be assessed from the Fasting Plasma LDL Cholesterol level of each participant following one month and two months supplementation.
8 secondary outcomes
Changes of Fasting lipid profile (total cholesterol)
Time frame: Baseline, day 30 and day 60 after supplementation
Changes of Fasting lipid profile (HDL cholesterol)
Time frame: Baseline,day 30 and day 60 after supplementation
Changes of Fasting lipid profile (Triglyceride)
Time frame: Baseline,day 30 and day 60 after supplementation
Changes of plasma inflammatory markers
Time frame: Baseline, day 30 and day 60 after supplementation
Changes of Plasma Antioxidant Levels
Time frame: Baseline, day 30 and day 60 after supplementation
Incidence of adverse events via evaluation of renal function test
Time frame: Baseline, day 30 and day 60 after supplementation
Incidence of adverse events via evaluation of liver function test
Time frame: Baseline, day 30 and day 60 after supplementation
Changes of Body weight measurement
Time frame: Baseline, day 30 and day 60 after supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: 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 37484009Muhammad Ismail Tadj NB, Ibrahim NI, Tg Abu Bakar Sidik TMI, Zulfarina MS, Haji Mohd Saad Q, Leow SS, Fairus S, Naina Mohamed I. Safety and efficacy of oil palm phenolic supplementation in improving lipid profile among hyperlipidemic adults: a phase 2, randomized, double-blind, placebo-controlled clinical trial. Front Pharmacol. 2023 Jul 7;14:1190663. doi: 10.3389/fphar.2023.1190663. eCollection 2023.
- 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 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 2 study testing 250 mg OPP in people with Hyperlipidemias and Hypercholesterolemia, run by Isa Naina Mohamed 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 9 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: finished, as of the sponsor's last update on 13 Apr 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of fasting plasma LDL cholesterol levels (time frame: Baseline, day 30, day 60 after supplementation). 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 NCT04573218, 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 13 Apr 2022.