Multi-country Study- Effect of Dietary Fats on Fat Deposition

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.

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Test Fat Blue; Other: Test Fat Green; Other: Test Fat Red

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Fat Blue; 16 weeks interventions	Other: Test Fat Blue; 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.
EXPERIMENTAL: Test Fat Green; 16 weeks interventions	Other: Test Fat Green; 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.
EXPERIMENTAL: Test Fat Red; 16 weeks interventions	Other: Test Fat Red; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of liver fat content	measured by magnetic resonance imaging (MRI) scan	week 0 (baseline) and week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body mass index (BMI)	measured by Tanita Segmental Body Fat Analysis	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of waist circumference		week 0 (baseline), week 4, week 8, week 12 and week 16
Change of body fat distribution/content		week 0 (baseline), week 4, week 8, week 12 and week 16
Change of visceral adiposity index (VAI)	analysed by visceral adiposity index (VAI)	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)	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	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	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	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	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	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	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum HDL-subfractions	measured by Lipoprint® HDL Subfractions Test	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum LDL-subfractions	measured by Lipoprint® LDL Subfractions Test	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Apolipoprotein A	measured by Siemens Advia 2400 Chemistry Analyzer	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Apolipoprotein B	measured by Siemens Advia 2400 Chemistry Analyzer	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of serum Lp (a)	measured by Siemens Advia 2400 Chemistry Analyzer	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)	week 0 (baseline), week 4, week 8, week 12 and week 16
Change of visceral adipose tissue	measured by MRI	week 0 (baseline) and week 16
Change of subcutaneous adipose tissue	measured by MRI	week 0 (baseline) and week 16
Change of serum interleukin-6 (IL-6)	analysed by ELISA development kits	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	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	week 0 (baseline), week 4, week 8, week 12 and week 16
Systolic and diastolic blood pressure	measured by blood pressure meter	week 0 (baseline), week 4, week 8, week 12 and week 16

Collaborators and Investigators

• Sponsor: Malaysia Palm Oil Board
• Collaborators: Universiti Putra Malaysia; International Medical University
• Investigators: Study Chair: Choo Yuen May, PhD, MPOB; Principal Investigator: Augustine Ong Soon Hock, PhD, MPOB; Principal Investigator: Verna Lee Kar Man, PhD, IMU; Principal Investigator: Norhaizan Mohd Esa, PhD, UPM; Principal Investigator: Teh Soek Sin, PhD, MPOB; Principal Investigator: Yap Sia Yen, PhD, MPOB; Principal Investigator: Ng Yen Teng, Bsc, MPOB

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (ESTIMATE): June 13, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PD 205/15 (b)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED