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

NCT ID: NCT02797483

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Test Fat Blue

16 weeks interventions

Group Type: EXPERIMENTAL

Test Fat Blue

Intervention Type: 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

16 weeks interventions

Group Type: EXPERIMENTAL

Test Fat Green

Intervention Type: 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

16 weeks interventions

Group Type: EXPERIMENTAL

Test Fat Red

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IMU University, Malaysia

OTHER

Sponsor Role: collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role: collaborator

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Choo Yuen May, PhD

Role: STUDY_CHAIR

MPOB

Augustine Ong Soon Hock, PhD

Role: PRINCIPAL_INVESTIGATOR

MPOB

Voon Phooi Tee, PhD

Role: PRINCIPAL_INVESTIGATOR

MPOB

Tony Ng Kock Wai, PhD

Role: PRINCIPAL_INVESTIGATOR

IMU

Verna Lee Kar Man, PhD

Role: PRINCIPAL_INVESTIGATOR

IMU

Norhaizan Mohd Esa, PhD

Role: PRINCIPAL_INVESTIGATOR

UPM

Teh Soek Sin, PhD

Role: PRINCIPAL_INVESTIGATOR

MPOB

Yap Sia Yen, PhD

Role: PRINCIPAL_INVESTIGATOR

MPOB

Ng Yen Teng, Bsc

Role: PRINCIPAL_INVESTIGATOR

MPOB

Other Identifiers

PD 205/15 (b)

Identifier Type: -

Identifier Source: org_study_id