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Completed

NCT Number: NCT02797483

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

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Fat Blue

Other

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 Green

Other

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 Red

Other

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.

Primary outcomes

  1. Change of liver fat content

    Time frame: week 0 (baseline) and week 16

    measured by magnetic resonance imaging (MRI) scan

Secondary outcomes

  1. Change of body mass index (BMI)

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

    measured by Tanita Segmental Body Fat Analysis

  2. Change of waist circumference

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

  3. Change of body fat distribution/content

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

  4. Change of visceral adiposity index (VAI)

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

    analysed by visceral adiposity index (VAI)

  5. Change of body adiposity index (BAI)

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

    analysed by visceral body adiposity index (BAI)

  6. Change of serum leptin

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

    analysed by enzyme-linked immunosorbent assay (ELISA) development kits

  7. Change of serum total cholesterol (TC)

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

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  8. Change of serum high-density lipoprotein cholesterol (HDLC)

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

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  9. Change of serum triacylglycerie (TAG)

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

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  10. Change of serum low-density lipoprotein (LDLC)

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

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  11. Change of serum lipoprotein ration (TC/HDLC)

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

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  12. Change of serum HDL-subfractions

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

    measured by Lipoprint® HDL Subfractions Test

  13. Change of serum LDL-subfractions

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

    measured by Lipoprint® LDL Subfractions Test

  14. Change of serum Apolipoprotein A

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

    measured by Siemens Advia 2400 Chemistry Analyzer

  15. Change of serum Apolipoprotein B

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

    measured by Siemens Advia 2400 Chemistry Analyzer

  16. Change of serum Lp (a)

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

    measured by Siemens Advia 2400 Chemistry Analyzer

  17. Faecal fatty acid composition (FAC)

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

    FAC of faecal extracted fat measured by gas chromatography (GC)

  18. Change of visceral adipose tissue

    Time frame: week 0 (baseline) and week 16

    measured by MRI

  19. Change of subcutaneous adipose tissue

    Time frame: week 0 (baseline) and week 16

    measured by MRI

  20. Change of serum interleukin-6 (IL-6)

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

    analysed by ELISA development kits

  21. Change of serum tumor necrosis factor alpha (TNF-α)

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

    analysed by ELISA development kits

  22. Change of serum high-sensitivity C-reactive protein (hsCRP)

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

    analysed by ELISA development kits

  23. Systolic and diastolic blood pressure

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

    measured by blood pressure meter

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • IMU University, Malaysia
  • Universiti Putra Malaysia

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2016
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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