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

M

Malaysia Palm Oil Board

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01428960
IMU R 069/2011

Details and patient eligibility

About

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.

Full 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).

Enrollment

36 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

36 participants in 3 patient groups

Palm Mid Fraction
Experimental group
Treatment:
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil
Shea Butter
Experimental group
Treatment:
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil
High Oleic Sunflower Oil
Experimental group
Treatment:
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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