HyperlipidemiasNCT06595472
Plant Sterol-Enriched Palm Oil to Improve Lipid Profile and Inflammation in Hyperlipidemic Individuals
A study testing Palm Oil Enriched with Plant Sterols and Palm oil in people with Hyperlipidemias, run by Institut Pertanian Bogor.
Trial summary
This is a placebo-controlled double-blinded trial aimed to evaluate the effect of palm oil enriched with plant sterols on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Palm Oil Enriched with Plant Sterols and Palm oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 1 Dec 2013
- Phase
- Interventional
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 25-60y
- total cholesterol concentration ≥200 mg/dL
- not requiring lipid-lowering drug therapy during the trial
Who cannot join
- secondary hyperlipidemia
- fasting triglyceride concentration >3.5 mmol/L
- body mass index >35 kg/m2
- use of any lipid-lowering drug
- suffering from gastrointestinal diseases or severe concomitant diseases
About this study
Official title: Effect of Plant Sterol-Enriched Palm Oil on Lipid Profile and Systemic Inflammation in Hyperlipidemic Adults: A Placebo-Controlled Double-Blinded Trial
This is a placebo-controlled double-blinded trial aimed to evaluate the effect of palm oil enriched with plant sterols on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. Subjects were assigned to intervention oil which contained plant sterol and control oil which was the same as the intervention oil but did not contain plant sterol for 8 weeks. Data collected included nutritional status, energy and macronutrients consumption, blood lipid profile and inflammatory marker (hsCRP).
Read the detailed description
Cardiovascular diseases, including coronary heart disease (CHD), are currently positioned amongst the leading causes of mortality globally. Risk factors of CHD include, among others, hypercholesterolemia and elevations in systemic inflammation. Functional foods enriched with compounds showing cholesterol-lowering effects are considered as one among various dietary and lifestyle intervention strategies to tackle this problem. A CHD-preventive effect of dietary plant sterols has been broadly discussed, not only due to their ability to reduce blood cholesterol level, but also to their proven anti-inflammatory potential. Palm oil is one amongst the most widely consumed edible oils in the world. Up to date, despite its widespread use, especially in Asian countries, no study has been conducted using palm oil as a vehicle for plant sterols. The aim of the placebo-controlled double-blinded trial presented here was therefore to evaluate the effect of palm oil enriched with plant sterols, used as a cooking oil, on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. The study had 2 arms; intervention group in which subjects were given oil which contained plant sterol and control group which in which subjects were given the same oil as the intervention group but did not contain plant sterol for 8 weeks. The oil was consumed as cooking oil. Data on energy, macro nutrients, and cooking oil consumption were collected through interviews at baseline, week 2, 4, 6, and endline. Body weight and height measurement for nutritional status assessment and blood sample collection for biomarker analysis was conducted at baseline and endline.
- Conditions
- Hyperlipidemias
- Being tested
- Palm Oil Enriched with Plant Sterols, Palm oil
- Keywords
- hyperlipidemia, plant sterol, C-reactive protein, Indonesia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm Oil Enriched with Plant SterolsDietary supplement
The enriched palm oil contained 52 mg/L of phytosterols, to reach the estimated intake of plant sterols in the treatment group at the level of around 2 g/day [22]. The phytosterols used was Vegapure 95 FF® derived from soybean derivatives containing campesterol, stigmasterol and beta-sitosterol. The oil is consumed by respondents as cooking oil.
Palm oilDietary supplement
The type, composition, and physical appearance of the oil is the same as those of the intervention arm, except that it was not added plant sterol. The oil is consumed by respondents as cooking oil.
| Study group | Role | What they receive |
|---|---|---|
| plant sterol-enriched palm oil | Experimental | The group given cooking oil (palm oil) which is Enriched with Plant Sterol. Receives: Dietary Supplement: Palm Oil Enriched with Plant Sterols |
| palm oil | Placebo comparator | The group given cooking oil (palm oil) which has the same composition and physical appearance as the intervention oil, but without plant sterol. Receives: Dietary Supplement: Palm oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipid profile
Concentration of blood HDL, LDL, triacylglycerols, and cholesterol (total) of participants after intervention period.
Measured: 8 weeks
Secondary outcomes (1)
Inflammatory marker
Concentration of high sensitivity C-Reactive protein of participants after intervention period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2012
- Primary completion1 Jun 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a double-blinded randomized controlled trial, with 8 week intervention period, and conducted in Bogor district, West Java, Indonesia. The study subjects were volunteers residing in Bogor city and Bogor district, with known mild-moderate hypercholesterolemia. Subjects were supplied with either control or treatment cooking oil bottle every week, to be consumed as substitution of usually used cooking oil.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pertanian Bogor
- Sponsor type
- University, hospital or other
- Collaborators
- BASF
- Responsible party
- Principal investigator, Mira Dewi, Institut Pertanian Bogor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595472
- Sponsor's protocol ID
- 16-L/IPB/4202
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant Sterol-Enriched Palm Oil on Lipid Profile and Systemic Inflammation in Hyperlipidemic Adults: A Placebo-Controlled Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT06595472
- Acronym / sponsor ID
- 16-L/IPB/4202
- Conditions
- Hyperlipidemias
- Keywords
- hyperlipidemia, plant sterol, C-reactive protein, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Institut Pertanian BogorUniversity, hospital or other
- Collaborators
- BASF
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 19 Sep 2024 (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.
This is a placebo-controlled double-blinded trial aimed to evaluate the effect of palm oil enriched with plant sterols on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. Subjects were assigned to intervention oil which contained plant sterol and control oil which was the same as the intervention oil but did not contain plant sterol for 8 weeks. Data collected included nutritional status, energy and macronutrients consumption, blood lipid profile and inflammatory marker (hsCRP).
Detailed description
Cardiovascular diseases, including coronary heart disease (CHD), are currently positioned amongst the leading causes of mortality globally. Risk factors of CHD include, among others, hypercholesterolemia and elevations in systemic inflammation. Functional foods enriched with compounds showing cholesterol-lowering effects are considered as one among various dietary and lifestyle intervention strategies to tackle this problem. A CHD-preventive effect of dietary plant sterols has been broadly discussed, not only due to their ability to reduce blood cholesterol level, but also to their proven anti-inflammatory potential. Palm oil is one amongst the most widely consumed edible oils in the world. Up to date, despite its widespread use, especially in Asian countries, no study has been conducted using palm oil as a vehicle for plant sterols. The aim of the placebo-controlled double-blinded trial presented here was therefore to evaluate the effect of palm oil enriched with plant sterols, used as a cooking oil, on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. The study had 2 arms; intervention group in which subjects were given oil which contained plant sterol and control group which in which subjects were given the same oil as the intervention group but did not contain plant sterol for 8 weeks. The oil was consumed as cooking oil. Data on energy, macro nutrients, and cooking oil consumption were collected through interviews at baseline, week 2, 4, 6, and endline. Body weight and height measurement for nutritional status assessment and blood sample collection for biomarker analysis was conducted at baseline and endline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study was designed as a double-blinded randomized controlled trial, with 8 week intervention period, and conducted in Bogor district, West Java, Indonesia. The study subjects were volunteers residing in Bogor city and Bogor district, with known mild-moderate hypercholesterolemia. Subjects were supplied with either control or treatment cooking oil bottle every week, to be consumed as substitution of usually used cooking oil.
| Arm | Type | Receives |
|---|---|---|
| plant sterol-enriched palm oil | Experimental | Dietary Supplement: Palm Oil Enriched with Plant SterolsThe group given cooking oil (palm oil) which is Enriched with Plant Sterol. |
| palm oil | Placebo comparator | Dietary Supplement: Palm oilThe group given cooking oil (palm oil) which has the same composition and physical appearance as the intervention oil, but without plant sterol. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 25-60y
- total cholesterol concentration ≥200 mg/dL
- not requiring lipid-lowering drug therapy during the trial
Key exclusion criteria (5 listed)
- secondary hyperlipidemia
- fasting triglyceride concentration >3.5 mmol/L
- body mass index >35 kg/m2
- use of any lipid-lowering drug
- suffering from gastrointestinal diseases or severe concomitant diseases
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 |
|---|---|---|
| Palm Oil Enriched with Plant SterolsThe enriched palm oil contained 52 mg/L of phytosterols, to reach the estimated intake of plant sterols in the treatment group at the level of around 2 g/day [22]. The phytosterols used was Vegapure 95 FF® derived from soybean derivatives containing campesterol, stigmasterol and beta-sitosterol. The oil is consumed by respondents as cooking oil. | Dietary supplement | plant sterol-enriched palm oil |
| Palm oilThe type, composition, and physical appearance of the oil is the same as those of the intervention arm, except that it was not added plant sterol. The oil is consumed by respondents as cooking oil. | Dietary supplement | palm oil |
Primary outcome
Blood lipid profile
Time frame: 8 weeks
Concentration of blood HDL, LDL, triacylglycerols, and cholesterol (total) of participants after intervention period.
1 secondary outcome
Inflammatory marker
Time frame: 8 weeks
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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Palm Oil Enriched with Plant Sterols and Palm oil in people with Hyperlipidemias, run by Institut Pertanian Bogor.
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 3 inclusion and 5 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Blood lipid profile (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.