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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428960
• Other study ID #: IMU R 069/2011
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: October 30, 2013
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2012
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Malaysia	Malaysian Palm Oil Board Kajang, Selangor,	Kajang	Selangor,

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	International Medical University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose-dependent insulintropic polypeptide (GIP)		4 hours	No
Secondary	Lipid profile		4 hours	No
Secondary	Inflammatory markers		4 hours	No
Secondary	Haemostatic indices		4 hours	No