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

Malaysia Palm Oil Board

Status: Completed

Conditions: Healthy

Treatments: Other: Test Fat Red; Other: Test Fat Green; Other: Test Fat Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT02797483

PD 205/15 (b)

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 3 patient groups

Test Fat Blue

Experimental group

Description:

16 weeks interventions

Treatment:

Other: Test Fat Blue

Test Fat Green

Experimental group

Description:

16 weeks interventions

Treatment:

Other: Test Fat Green

Test Fat Red

Experimental group

Description:

16 weeks interventions

Treatment:

Other: Test Fat Red