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

NCT02797483 | Completed

• 1 other identifier: PD 205/15 (b)
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change of liver fat content

  measured by magnetic resonance imaging (MRI) scan

  week 0 (baseline) and week 16

Secondary Outcomes (23)

• Change of body mass index (BMI)

  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)

  week 0 (baseline), week 4, week 8, week 12 and week 16

• Change of body adiposity index (BAI)

  week 0 (baseline), week 4, week 8, week 12 and week 16

Study Arms (3)

Test Fat Blue

EXPERIMENTAL

16 weeks interventions

Other: Test Fat Blue

Test Fat Green

EXPERIMENTAL

16 weeks interventions

Other: Test Fat Green

Test Fat Red

EXPERIMENTAL

16 weeks interventions

Other: Test Fat Red

Interventions

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 Blue

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 Green

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.

Test Fat Red

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female, aged 20-60 years
• BMI 18-5-27.5 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Malaysia Palm Oil Board: lead
• IMU University, Malaysia: collaborator
• Universiti Putra Malaysia: collaborator

Study Officials

• Choo Yuen May, PhD

  MPOB

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 13, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 13, 2016

Record last verified: 2016-06