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Completed

NCT Number: NCT01428960

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysian Palm Oil Board Kajang, Selangor,

Kajang, Selangor, 43000, Malaysia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Dietary Supplement

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 names: POP vs SOS vs OOO

Primary outcomes

  1. glucose-dependent insulintropic polypeptide (GIP)

    Time frame: 4 hours

Secondary outcomes

  1. Lipid profile

    Time frame: 4 hours

  2. Inflammatory markers

    Time frame: 4 hours

  3. Haemostatic indices

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • IMU University, Malaysia

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 5, 2011
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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