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

Acute Effects 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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor,
    • Kajang, Selangor,, Malaysia, 43000
      • Malaysian Palm Oil Board Kajang, Selangor,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Palm Mid Fraction	Dietary supplement: 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; Other Names: POP vs SOS vs OOO
EXPERIMENTAL: Shea Butter	Dietary supplement: 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; Other Names: POP vs SOS vs OOO
EXPERIMENTAL: High Oleic Sunflower Oil	Dietary supplement: 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; Other Names: POP vs SOS vs OOO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
glucose-dependent insulintropic polypeptide (GIP)	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Lipid profile	4 hours
Inflammatory markers	4 hours
Haemostatic indices	4 hours

Collaborators and Investigators

• Sponsor: Malaysia Palm Oil Board
• Collaborators: International Medical University
• Investigators: Principal Investigator: Tony Ng, International Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: September 2, 2011
• First Posted (ESTIMATE): September 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Insulin; Cholesterol; Inflammatory markers; Satiety; Gut hormone; Palm mid fraction; Shea butter; sn-1, sn-3 fatty acids; Postprandial lipemia,
• Other Study ID Numbers: IMU R 069/2011