Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers

NCT02802904 | Completed DMC

• 1 other identifier: PD205/15- STUDY 1 (A)
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fats and oils are made up of \>90% triacylglycerol 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. There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (16:0) or stearic acid (18:0) 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 (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. In this proposed study, the effects on the outcome measures investigated of three test fats \[namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)\], with oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated

Conditions

Cardiovascular Risk Factor

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)

  analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  week 0 (baseline) and week 4

Secondary Outcomes (9)

• changes of serum HDL cholesterol

  week 0 (baseline) and week 4

• changes of serum LDL cholesterol

  week 0 (baseline) and week 4

• changes of serum Triacylglycerol (TAG)

  week 0 (baseline) and week 4

• changes of serum non-esterified fatty acids (NEFA)

  week 0 (baseline) and week 4

• changes of serum LDL sub-fractions

  week 0 (baseline) and week 4

Study Arms (3)

Palm olein IV 64

EXPERIMENTAL

Palm olein IV 64, n= 15, 4 weeks intervention

Other: Diet: Palm olein IV64

Cocoa butter

EXPERIMENTAL

Cocoa butter, n= 15, 4 weeks intervention

Other: Diet: Cocoa butter

Virgin olive oil

EXPERIMENTAL

Virgin olive oil, n= 15, 4 weeks intervention

Other: Diet: Virgin olive oil

Interventions

Diet: Palm olein IV64 OTHER

Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (\~50g of test fats, brownies (\~15g test fat each) for breakfast and 4 pieces cookies (\~5g test fat each) with low fat palm olein based background diet daily.

Palm olein IV 64

Diet: Cocoa butter OTHER

Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (\~50g of test fats, brownies (\~15g test fat each) for breakfast and 4 pieces cookies (\~5g test fat each) with low fat palm olein based background diet daily.

Cocoa butter

Diet: Virgin olive oil OTHER

Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (\~50g of test fats, brownies (\~15g test fat each) for breakfast and 4 pieces cookies (\~5g test fat each) with low fat palm olein based background diet daily.

Virgin olive oil

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female, aged 20-50 years
• BMI 18.5- 24.9 kg/m2 as per WHO Classification (1998)

You may not qualify if:

• Hyperlipidemia (TC\>6.2 mmol/L, TAG \>2.0 mmol/L)
• History of chronic disease- type 2 DM, heart disease, cancer
• Habitual smokers (\>2 sticks a day)
• Hypertensives: \>140/90 mmHg
• On medication/nutraceuticals to reduce blood lipids, blood pressure
• Pregnant or lactating women
• Planned trip abroad/overseas during period of study

Sponsors & Collaborators

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

Study Officials

• Datuk Dr. Choo Yuen May, PhD

  MPOB

  STUDY CHAIR

• Emeritus Prof. Datuk Dr. Augustine Ong Soon Hock, PhD

  Malaysian Oil Scientists and Technologists' Association (MOSTA)

  STUDY CHAIR

• Assoc Prof Dr Tony Ng Kock Wai, PhD

  IMU

  PRINCIPAL INVESTIGATOR

• Dr Kanga Rani Selvaduray, PhD

  MPOB

  PRINCIPAL INVESTIGATOR

• Radhika Loganathan, MSc

  MPOB

  PRINCIPAL INVESTIGATOR

• Dr Darren Gouk Siew Wah, PhD

  MPOB

  PRINCIPAL INVESTIGATOR

• Gowri Nagapan, MSc

  MPOB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06