Clinical trial NCT01428960: Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Palm mid fraction
Shea butter
sn-1, sn-3 fatty acids
Cholesterol
Postprandial lipemia,
Inflammatory markers
Satiety
Gut hormone
Insulin
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: International Medical University
First posted: 2011-09-05
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: glucose-dependent insulintropic polypeptide (GIP)
timeFrame: 4 hours
Secondary outcomes:
measure: Lipid profile
timeFrame: 4 hours
measure: Inflammatory markers
timeFrame: 4 hours
measure: Haemostatic indices
timeFrame: 4 hours
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board Kajang, Selangor,
state: Selangor,
Study officials:
affiliation: International Medical University
name: Tony Ng
role: PRINCIPAL_INVESTIGATOR
References: