HealthyNCT01428960
Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers
A study testing Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil in people with Healthy, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2011to May 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female staff, aged between 25-50 years
- BMI 18.5 - 25.0 kg/m2
- Blood pressure: Systolic: <140 mmHg, diastolic: <90 mmHg
- Normolipidemic (Total cholesterol <6.2 mM/L (<240 mg/dL), Fasting TG <1.70 mM/L (<150 mg/dL) d. Fasting glucose 4.0- 7.0 mM/L
Who cannot join
- Smokers
- On cholesterol or blood glucose medication
- Substance abuse (eg. alcohol, cigarette smoking)
- For women, pregnant or lactating
- Going overseas during period of study
- Blood clotting problem
- Public transportation to work
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Malaysian Palm Oil Board Kajang, Selangor,
Kajang, Selangor, 43000
About this study
Official title: Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Postprandial Lipemia, Haemostatic and Inflammatory Markers, Gut Hormone Concentrations, Satiety, and Insulinemic Response in Human Volunteers
To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects.
Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.
Read the detailed description
The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test fat [palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)] will be compared which will be in a form of experimental meals (muffin).
33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.
At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).
- Conditions
- Healthy
- Being tested
- Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil
- Keywords
- Palm mid fraction, Shea butter, sn-1, sn-3 fatty acids, Cholesterol, Postprandial lipemia,, Inflammatory markers, Satiety, Gut hormone, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm Mid Fraction, Shea Butter, High Oleic Sunflower OilDietary supplement
Also called POP vs SOS vs OOO
Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between
| Study group | Role | What they receive |
|---|---|---|
| Palm Mid Fraction | Experimental | Not described Receives: Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
| Shea Butter | Experimental | Not described Receives: Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
| High Oleic Sunflower Oil | Experimental | Not described Receives: Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose-dependent insulintropic polypeptide (GIP)
Measured: 4 hours
Secondary outcomes (3)
Lipid profile
Measured: 4 hours
Inflammatory markers
Measured: 4 hours
Haemostatic indices
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- IMU University, Malaysia
- Responsible party
- Sponsor
- Investigators
- Tony Ng, Principal investigator, IMU University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428960
- Sponsor's protocol ID
- IMU R 069/2011
- Status last verified
- Oct 2012
- First submitted
- 26 Aug 2011
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Postprandial Lipemia, Haemostatic and Inflammatory Markers, Gut Hormone Concentrations, Satiety, and Insulinemic Response in Human Volunteers
- ClinicalTrials.gov ID
- NCT01428960
- Acronym / sponsor ID
- IMU R 069/2011
- Conditions
- Healthy
- Keywords
- Palm mid fraction, Shea butter, sn-1, sn-3 fatty acids, Cholesterol, Postprandial lipemia,, Inflammatory markers, Satiety, Gut hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- IMU University, Malaysia
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Sep 2011 (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.
To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects.
Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.
Detailed description
The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test fat [palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)] will be compared which will be in a form of experimental meals (muffin).
33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.
At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palm Mid Fraction | Experimental | Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
| Shea Butter | Experimental | Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
| High Oleic Sunflower Oil | Experimental | Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male or female staff, aged between 25-50 years
- BMI 18.5 - 25.0 kg/m2
- Blood pressure: Systolic: <140 mmHg, diastolic: <90 mmHg
- Normolipidemic (Total cholesterol <6.2 mM/L (<240 mg/dL), Fasting TG <1.70 mM/L (<150 mg/dL) d. Fasting glucose 4.0- 7.0 mM/L
Key exclusion criteria (7 listed)
- Smokers
- On cholesterol or blood glucose medication
- Substance abuse (eg. alcohol, cigarette smoking)
- For women, pregnant or lactating
- Going overseas during period of study
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 Mid Fraction, Shea Butter, High Oleic Sunflower OilAlso: POP vs SOS vs OOOAcute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between | Dietary supplement | High Oleic Sunflower Oil, Palm Mid Fraction, Shea Butter |
Primary outcome
glucose-dependent insulintropic polypeptide (GIP)
Time frame: 4 hours
3 secondary outcomes
Lipid profile
Time frame: 4 hours
Inflammatory markers
Time frame: 4 hours
Haemostatic indices
Time frame: 4 hours
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 31 Oct 2013.
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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.
Tony Ng principal investigator
IMU University, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil in people with Healthy, 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 4 inclusion and 7 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 31 Oct 2013. 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?
glucose-dependent insulintropic polypeptide (GIP) (time frame: 4 hours). 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 31 Oct 2013.