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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

• Registration Number: NCT01428960
• Lead Sponsor: Malaysia Palm Oil Board

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Status Verified: 2012-10
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Palm Mid Fraction	Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil	-
Shea Butter	Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil	-
High Oleic Sunflower Oil	Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil	-

Primary Outcome Measures

Name	Time	Method
glucose-dependent insulintropic polypeptide (GIP)	4 hours

Secondary Outcome Measures

Name	Time	Method
Lipid profile	4 hours
Inflammatory markers	4 hours
Haemostatic indices	4 hours

Trial Locations

Locations (1)

Malaysian Palm Oil Board Kajang, Selangor,; 🇲🇾 Kajang, Selangor,, Malaysia