Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers

NCT ID: NCT01428960

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-05-31

Brief Summary

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To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects.

Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.

Detailed Description

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The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test fat \[palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)\] will be compared which will be in a form of experimental meals (muffin).

33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.

At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).

Conditions

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Healthy

Keywords

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Palm mid fraction Shea butter sn-1, sn-3 fatty acids Cholesterol Postprandial lipemia, Inflammatory markers Satiety Gut hormone Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Palm Mid Fraction

Group Type EXPERIMENTAL

Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Intervention Type DIETARY_SUPPLEMENT

Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between

Shea Butter

Group Type EXPERIMENTAL

Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Intervention Type DIETARY_SUPPLEMENT

Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between

High Oleic Sunflower Oil

Group Type EXPERIMENTAL

Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Intervention Type DIETARY_SUPPLEMENT

Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between

Interventions

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Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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POP vs SOS vs OOO

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult male or female staff, aged between 25-50 years
2. BMI 18.5 - 25.0 kg/m2
3. Blood pressure: Systolic: \<140 mmHg, diastolic: \<90 mmHg

c. Normolipidemic (Total cholesterol \<6.2 mM/L (\<240 mg/dL), Fasting TG \<1.70 mM/L (\<150 mg/dL) d. Fasting glucose 4.0- 7.0 mM/L

Exclusion Criteria

1. Smokers
2. On cholesterol or blood glucose medication
3. Substance abuse (eg. alcohol, cigarette smoking)
4. For women, pregnant or lactating
5. Going overseas during period of study
6. Blood clotting problem
7. Public transportation to work
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IMU University, Malaysia

OTHER

Sponsor Role collaborator

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tony Ng

Role: PRINCIPAL_INVESTIGATOR

IMU University, Malaysia

Locations

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Malaysian Palm Oil Board Kajang, Selangor,

Kajang, Selangor, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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IMU R 069/2011

Identifier Type: -

Identifier Source: org_study_id