Clinical trial NCT02797483: Multi-country Study- Effect of Dietary Fats on Fat Deposition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: International Medical University
name: Universiti Putra Malaysia
First posted: 2016-06-13
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female, aged 20-60 years
* BMI 18-5-27.5 kg/m2

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Change of liver fat content
timeFrame: week 0 (baseline) and week 16
Secondary outcomes:
measure: Change of body mass index (BMI)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of waist circumference
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of body fat distribution/content
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of visceral adiposity index (VAI)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of body adiposity index (BAI)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum leptin
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum total cholesterol (TC)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum high-density lipoprotein cholesterol (HDLC)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum triacylglycerie (TAG)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum low-density lipoprotein (LDLC)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum lipoprotein ration (TC/HDLC)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum HDL-subfractions
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum LDL-subfractions
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum Apolipoprotein A
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum Apolipoprotein B
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum Lp (a)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Faecal fatty acid composition (FAC)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of visceral adipose tissue
timeFrame: week 0 (baseline) and week 16
measure: Change of subcutaneous adipose tissue
timeFrame: week 0 (baseline) and week 16
measure: Change of serum interleukin-6 (IL-6)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum tumor necrosis factor alpha (TNF-α)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Change of serum high-sensitivity C-reactive protein (hsCRP)
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
measure: Systolic and diastolic blood pressure
timeFrame: week 0 (baseline), week 4, week 8, week 12 and week 16
Other outcomes:
Locations:
Study officials:
affiliation: MPOB
name: Choo Yuen May, PhD
role: STUDY_CHAIR
affiliation: MPOB
name: Augustine Ong Soon Hock, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Voon Phooi Tee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMU
name: Tony Ng Kock Wai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMU
name: Verna Lee Kar Man, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPM
name: Norhaizan Mohd Esa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Teh Soek Sin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Yap Sia Yen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Ng Yen Teng, Bsc
role: PRINCIPAL_INVESTIGATOR
References: