Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| 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 |
- glucose-dependent insulintropic polypeptide (GIP) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Lipid profile [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Inflammatory markers [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Haemostatic indices [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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 Name: 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 Name: POP vs SOS vs OOO
|
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| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult male or female staff, aged between 25-50 years
- BMI 18.5 - 25.0 kg/m2
- 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:
- Smokers
- On cholesterol or blood glucose medication
- Substance abuse (eg. alcohol, cigarette smoking)
- For women, pregnant or lactating
- Going overseas during period of study
- Blood clotting problem
- Public transportation to work
Contacts and Locations| Malaysia | |
| Malaysian Palm Oil Board Kajang, Selangor, | |
| Kajang, Selangor,, Malaysia, 43000 | |
| Principal Investigator: | Tony Ng | International Medical University |
More Information
No publications provided
| Responsible Party: | Malaysia Palm Oil Board |
| ClinicalTrials.gov Identifier: | NCT01428960 History of Changes |
| Other Study ID Numbers: | IMU R 069/2011 |
| Study First Received: | August 26, 2011 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Malaysia: Ministry of Health |
Keywords provided by Malaysia Palm Oil Board:
|
Palm mid fraction Shea butter sn-1, sn-3 fatty acids Cholesterol Postprandial lipemia, |
Inflammatory markers Satiety Gut hormone Insulin |
Additional relevant MeSH terms:
|
Hemostatics Hormones Palmitic Acid Coagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013