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

This study has been completed.
Sponsor:
Collaborator:
International Medical University
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01428960
First received: August 26, 2011
Last updated: October 30, 2013
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • glucose-dependent insulintropic polypeptide (GIP) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: June 2011
Study Completion Date: May 2013
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428960

Locations
Malaysia
Malaysian Palm Oil Board Kajang, Selangor,
Kajang, Selangor,, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
International Medical University
Investigators
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 30, 2013
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:
Hormones
Palmitic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014