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

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ClinicalTrials.gov Identifier: NCT02797483
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Collaborators:
International Medical University
Universiti Putra Malaysia
Information provided by (Responsible Party):
Malaysia Palm Oil Board

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Test Fat Blue Other: Test Fat Green Other: Test Fat Red Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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.




Primary Outcome Measures :
  1. Change of liver fat content [ Time Frame: week 0 (baseline) and week 16 ]
    measured by magnetic resonance imaging (MRI) scan


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797483


Sponsors and Collaborators
Malaysia Palm Oil Board
International Medical University
Universiti Putra Malaysia
Investigators
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Study Chair: Choo Yuen May, PhD MPOB
Principal Investigator: Augustine Ong Soon Hock, PhD MPOB
Principal Investigator: Voon Phooi Tee, PhD MPOB
Principal Investigator: Tony Ng Kock Wai, PhD IMU
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

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Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT02797483     History of Changes
Other Study ID Numbers: PD 205/15 (b)
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided