Lipid ProfileNCT01124487
The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
A study testing The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers in people with Lipid Profile, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers. Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Profile
- What is being tested?
- The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2009to Sep 2009
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 years
- BMI : 18.5-30 kg/m^2
- Healthy, men
Who cannot join
- medical history of cardiovascular disease, cancer, diabetes or chronic diseases
- BMI < 18.5 OR > 30 kg/m^2
- waist hip ratio > 0.9
- total cholesterol > 5.2 mmol/L
- triacylglycerol (TAG) > 2.2 mmol/L
- current use of antihypertensive or lipid lowering medication
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers.
Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially.
Read the detailed description
A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially.
Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers
- Conditions
- Lipid Profile
- Being tested
- The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
- Keywords
- fat, inflammation, lipids, total cholesterol, Triglycerides, insulin sensitivity
- Medical subject headings
- Platelet Glycoprotein IV Deficiency, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markersDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| palm olein | Experimental | Not described Receives: Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers |
| olive oil | Experimental | Not described Receives: Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers |
| lard | Experimental | Not described Receives: Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triacylglycerol (TAG)
Measured: 4 h
Secondary outcomes (1)
Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers
Measured: 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid ProfileStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Investigators
- Teng Kim Tiu, Msc, Principal investigator, Malaysia Palm Oil Board and University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124487
- Sponsor's protocol ID
- A001/09
- Status last verified
- May 2010
- First submitted
- 12 May 2010
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
- ClinicalTrials.gov ID
- NCT01124487
- Acronym / sponsor ID
- A001/09
- Conditions
- Lipid Profile
- Keywords
- fat, inflammation, lipids, total cholesterol, Triglycerides, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- University of Malaya
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 May 2010 (estimated)
- 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.
Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers.
Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially.
Detailed description
A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially.
Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| palm olein | Experimental | Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers |
| olive oil | Experimental | Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers |
| lard | Experimental | Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-45 years
- BMI : 18.5-30 kg/m^2
- Healthy, men
Key exclusion criteria (6 listed)
- medical history of cardiovascular disease, cancer, diabetes or chronic diseases
- BMI < 18.5 OR > 30 kg/m^2
- waist hip ratio > 0.9
- total cholesterol > 5.2 mmol/L
- triacylglycerol (TAG) > 2.2 mmol/L
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 |
|---|---|---|
| The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers | Dietary supplement | lard, olive oil, palm olein |
Primary outcome
Triacylglycerol (TAG)
Time frame: 4 h
1 secondary outcome
Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers
Time frame: 4 h
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 17 May 2010.
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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.
Teng Kim Tiu, Msc principal investigator
Malaysia Palm Oil Board and University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers in people with Lipid Profile, run by Malaysia Palm Oil Board 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 3 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: finished, as of the sponsor's last update on 17 May 2010. 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. 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?
Triacylglycerol (TAG) (time frame: 4 h). 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 17 May 2010.