HealthyNCT02797483
Multi-country Study- Effect of Dietary Fats on Fat Deposition
A study testing Test Fat Blue, Test Fat Green and Test Fat Red in people with Healthy, run by Malaysia Palm Oil Board.
Trial summary
There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (C16:0) or stearic acid (C18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test Fat Blue, Test Fat Green and Test Fat Red
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female, aged 20-60 years
- BMI 18-5-27.5 kg/m2
Who cannot join
- History of any one of these chronic diseases - type 2 DM, hypertension, coronary heart disease, hyperlipidemia, liver disease, cancer
- Current problem with indigestion or constipation or bowel movement
- On medication/nutraceutiucals to reduce blood lipids or blood pressure or weight
- Pregnant or lactating women or taking COCP
- Habitual smokers (>2 sticks per day)
- Alcoholism (>21 units per week for men \& >14 units per week for women)
Show all 10Show fewer
- Mean screening blood pressure >140/90 mmHg
- Screening TC>6.2 mmol/L or TAG >2.0 mmol/L
- Planned trip abroad/overseas during period of study
- Unable to adhere to at least 90% of the prescribed oil \& recommended energy and fat per day per research protocol
About this study
Official title: Multi-country Studies on the Effect of Positional Distribution of Fatty Acids at the Triglyceride Backbone of Vegetable Oils on Fat Deposition and Selected Health Outcome Measures - Malaysia
There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (C16:0) or stearic acid (C18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the "sn-2 hypothesis". New evidence have also emerged to show that saturated fatty acids (C16:0, C18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. Therefore, further studies in humans are warranted to confirm these earlier findings.
Fats and oils are made up of >90% triacylglycerol (TAG)- fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. Early evidence shown that the unique stereospecificity of fatty acid distribution on the palm fat molecule conferred health benefits in that it inhibited experimental atherosclerosis in the rabbit model.
Read more
In vegetable oils, oleic acid [a monounsaturated fatty acid (MUFA)] is predominantly situated at the sn-2 position, while in animals fats it is predominantly palmitic acid or stearic acid (C16:0 or C18:0-saturated fat) that is situated there. Even though palm olein and lard have similar proportions of saturated fatty acid (SFA), MUFA and polyunsatuared fatty acid (PUFA), they differ significantly in their positional distribution on the TAG molecule. Palm olein TAG contains only 7-11 % palmitic acid at the sn-2 position while about 87% is unsaturated fatty acids (oleic acid and linoleic acid). Lard has the highest amount of palmitic acid in the sn-2 position at 70%. On the other hand, in human milk, palmitic acid is predominantly in sn-2 (53-57 %) while cow milk fat contains less palmitic acid (38 %) there. It is now believed that the distribution of fatty acids in the TAG is more important than the fatty acid composition alone in conferring the oils' 'saturated' or 'unsaturated' properties.
In this proposed study, the effects on the outcome measures investigated of different fatty acids (palmitic acid, oleic acid, linoleic acid) at the sn-1, sn-2 and sn-3 positions of the TAG molecule in three different test fats will be investigated.
- Conditions
- Healthy
- Being tested
- Test Fat Blue, Test Fat Green, Test Fat Red
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Fat BlueOther
Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Blue which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks.
Test Fat GreenOther
Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Green which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks.
Test Fat RedOther
Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Red which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Fat Blue | Experimental | 16 weeks interventions Receives: Other: Test Fat Blue |
| Test Fat Green | Experimental | 16 weeks interventions Receives: Other: Test Fat Green |
| Test Fat Red | Experimental | 16 weeks interventions Receives: Other: Test Fat Red |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of liver fat content
measured by magnetic resonance imaging (MRI) scan
Measured: week 0 (baseline) and week 16
Secondary outcomes (23)
Change of body mass index (BMI)
measured by Tanita Segmental Body Fat Analysis
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of waist circumference
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of body fat distribution/content
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of visceral adiposity index (VAI)
analysed by visceral adiposity index (VAI)
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of body adiposity index (BAI)
analysed by visceral body adiposity index (BAI)
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum leptin
analysed by enzyme-linked immunosorbent assay (ELISA) development kits
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum total cholesterol (TC)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum high-density lipoprotein cholesterol (HDLC)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum triacylglycerie (TAG)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum low-density lipoprotein (LDLC)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum lipoprotein ration (TC/HDLC)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum HDL-subfractions
measured by Lipoprint® HDL Subfractions Test
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum LDL-subfractions
measured by Lipoprint® LDL Subfractions Test
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Apolipoprotein A
measured by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Apolipoprotein B
measured by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Lp (a)
measured by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Faecal fatty acid composition (FAC)
FAC of faecal extracted fat measured by gas chromatography (GC)
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of visceral adipose tissue
measured by MRI
Measured: week 0 (baseline) and week 16
Change of subcutaneous adipose tissue
measured by MRI
Measured: week 0 (baseline) and week 16
Change of serum interleukin-6 (IL-6)
analysed by ELISA development kits
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum tumor necrosis factor alpha (TNF-α)
analysed by ELISA development kits
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum high-sensitivity C-reactive protein (hsCRP)
analysed by ELISA development kits
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Systolic and diastolic blood pressure
measured by blood pressure meter
Measured: week 0 (baseline), week 4, week 8, week 12 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- IMU University, Malaysia, Universiti Putra Malaysia
- Responsible party
- Sponsor
- Investigators
- Choo Yuen May, PhD, Study chair, MPOBAugustine Ong Soon Hock, PhD, Principal investigator, MPOBVoon Phooi Tee, PhD, Principal investigator, MPOBTony Ng Kock Wai, PhD, Principal investigator, IMUVerna Lee Kar Man, PhD, Principal investigator, IMUNorhaizan Mohd Esa, PhD, Principal investigator, UPMTeh Soek Sin, PhD, Principal investigator, MPOBYap Sia Yen, PhD, Principal investigator, MPOB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797483
- Sponsor's protocol ID
- PD 205/15 (b)
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-country Studies on the Effect of Positional Distribution of Fatty Acids at the Triglyceride Backbone of Vegetable Oils on Fat Deposition and Selected Health Outcome Measures - Malaysia
- ClinicalTrials.gov ID
- NCT02797483
- Acronym / sponsor ID
- PD 205/15 (b)
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- IMU University, Malaysia, Universiti Putra Malaysia
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jun 2016 (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.
There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (C16:0) or stearic acid (C18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the "sn-2 hypothesis". New evidence have also emerged to show that saturated fatty acids (C16:0, C18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. Therefore, further studies in humans are warranted to confirm these earlier findings.
Fats and oils are made up of >90% triacylglycerol (TAG)- fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. Early evidence shown that the unique stereospecificity of fatty acid distribution on the palm fat molecule conferred health benefits in that it inhibited experimental atherosclerosis in the rabbit model.
In vegetable oils, oleic acid [a monounsaturated fatty acid (MUFA)] is predominantly situated at the sn-2 position, while in animals fats it is predominantly palmitic acid or stearic acid (C16:0 or C18:0-saturated fat) that is situated there. Even though palm olein and lard have similar proportions of saturated fatty acid (SFA), MUFA and polyunsatuared fatty acid (PUFA), they differ significantly in their positional distribution on the TAG molecule. Palm olein TAG contains only 7-11 % palmitic acid at the sn-2 position while about 87% is unsaturated fatty acids (oleic acid and linoleic acid). Lard has the highest amount of palmitic acid in the sn-2 position at 70%. On the other hand, in human milk, palmitic acid is predominantly in sn-2 (53-57 %) while cow milk fat contains less palmitic acid (38 %) there. It is now believed that the distribution of fatty acids in the TAG is more important than the fatty acid composition alone in conferring the oils' 'saturated' or 'unsaturated' properties.
In this proposed study, the effects on the outcome measures investigated of different fatty acids (palmitic acid, oleic acid, linoleic acid) at the sn-1, sn-2 and sn-3 positions of the TAG molecule in three different test fats will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Fat Blue | Experimental | Other: Test Fat Blue16 weeks interventions |
| Test Fat Green | Experimental | Other: Test Fat Green16 weeks interventions |
| Test Fat Red | Experimental | Other: Test Fat Red16 weeks interventions |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult male or female, aged 20-60 years
- BMI 18-5-27.5 kg/m2
Key exclusion criteria (10 listed)
- History of any one of these chronic diseases - type 2 DM, hypertension, coronary heart disease, hyperlipidemia, liver disease, cancer
- Current problem with indigestion or constipation or bowel movement
- On medication/nutraceutiucals to reduce blood lipids or blood pressure or weight
- Pregnant or lactating women or taking COCP
- Habitual smokers (>2 sticks per day)
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 |
|---|---|---|
| Test Fat BlueEach subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Blue which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks. | Other | Test Fat Blue |
| Test Fat GreenEach subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Green which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks. | Other | Test Fat Green |
| Test Fat RedEach subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Red which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks. | Other | Test Fat Red |
Primary outcome
Change of liver fat content
Time frame: week 0 (baseline) and week 16
measured by magnetic resonance imaging (MRI) scan
23 secondary outcomes
Change of body mass index (BMI)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of waist circumference
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of body fat distribution/content
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of visceral adiposity index (VAI)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of body adiposity index (BAI)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum leptin
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum total cholesterol (TC)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum high-density lipoprotein cholesterol (HDLC)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum triacylglycerie (TAG)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum low-density lipoprotein (LDLC)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum lipoprotein ration (TC/HDLC)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum HDL-subfractions
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum LDL-subfractions
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Apolipoprotein A
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Apolipoprotein B
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Lp (a)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Faecal fatty acid composition (FAC)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of visceral adipose tissue
Time frame: week 0 (baseline) and week 16
Change of subcutaneous adipose tissue
Time frame: week 0 (baseline) and week 16
Change of serum interleukin-6 (IL-6)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum tumor necrosis factor alpha (TNF-α)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum high-sensitivity C-reactive protein (hsCRP)
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
Systolic and diastolic blood pressure
Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16
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 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Choo Yuen May, PhD study chair
MPOB
Augustine Ong Soon Hock, PhD principal investigator
MPOB
Voon Phooi Tee, PhD principal investigator
MPOB
Questions about this trial
What is this clinical trial studying?
A study testing Test Fat Blue, Test Fat Green and Test Fat Red in people with Healthy, run by Malaysia Palm Oil Board.
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 2 inclusion and 10 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 Jun 2016. 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. 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?
Change of liver fat content (time frame: week 0 (baseline) and week 16). 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 13 Jun 2016.