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

Malaysia Palm Oil Board102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of liver fat content

measured by magnetic resonance imaging (MRI) scan

Time frame: week 0 (baseline) and week 16

Secondary Outcomes

Change of body mass index (BMI)

measured by Tanita Segmental Body Fat Analysis

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)

analysed by visceral adiposity index (VAI)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Change of serum HDL-subfractions

measured by Lipoprint® HDL Subfractions Test

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Change of serum LDL-subfractions

measured by Lipoprint® LDL Subfractions Test

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Change of serum Apolipoprotein A

measured by Siemens Advia 2400 Chemistry Analyzer

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Change of serum Apolipoprotein B

measured by Siemens Advia 2400 Chemistry Analyzer

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Change of serum Lp (a)

measured by Siemens Advia 2400 Chemistry Analyzer

Time frame: 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)

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Change of visceral adipose tissue

measured by MRI

Time frame: week 0 (baseline) and week 16

Change of subcutaneous adipose tissue

measured by MRI

Time frame: week 0 (baseline) and week 16

Change of serum interleukin-6 (IL-6)

analysed by ELISA development kits

Time frame: 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

Time frame: 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

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

Systolic and diastolic blood pressure

measured by blood pressure meter

Time frame: week 0 (baseline), week 4, week 8, week 12 and week 16

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes