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Completed

NCT Number: NCT01626430

Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome

Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.

Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysia Palm Oil Board, Kajang, Selangor, Malaysia

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About this study

A randomised, double-blind, crossover trial will be undertaken to test the acute effects of supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to attend during postprandial period and these occasions will be separated by at least one week. On the day preceding the postprandial high fat meal challenge, subjects will be asked to avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects will be provided with a standardised low fat meal (containing < 10 g fat) on the day preceding the postprandial study days to consume as their evening meal. They will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10 pm. Fasting blood samples will be collected on the next day and subjects will then consume the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood samples will be collected at regular intervals for up to 6 hours postprandially.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 20-60 years
  • BMI ≥ 25 kg/m2
  • Elevated triacylglycerols ≥ 1.70 mmol/L
  • Low HDL cholesterol < 1.04 mmol/L (men), < 1.30 mmol/L (women)
  • Elevated blood pressure ≥ 130/ ≥ 85 mmHg
  • Fasting plasma glucose ≥ 5.60 - 7.00 mmol/L
  • Increased waist circumference ≥ 90 cm (men), ≥ 80 cm (women)

Exclusion criteria

  • BMI ≤ 18.5 kg/m2
  • Current use of antihypertensive or lipid lowering, insulin/glucose modulating medication
  • Lactose/milk intolerance
  • Alcohol intake exceeding a moderate intake (> 28 units per week)
  • Smoker
  • Pregnancy or lactation
  • Fever, cold and infection during bleeding day

Treatment and study plan

Gamma delta TRF

Dietary Supplement

50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.

Placebo

Dietary Supplement

50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.

Primary outcomes

  1. C-peptide

    Time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min

Secondary outcomes

  1. Insulin sensitivity (insulin, glucose)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min

  2. Non-esterified fatty acid (NEFA)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min

  3. Serum triglycerides (TAG)

    Time frame: 0, 60, 120, 180, 240, 300, 360 min

  4. Inflammatory markers (IL-6, IL-1β, TNF-α)

    Time frame: 0, 120, 240, 360 min

  5. PBMC nuclear factor-κappa B (NF-κB)

    Time frame: 0, 240, 360 min

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • University of Malaya

Registry information

Official study title

Acute Effects of Tocotrienols on Insulinaemic and Inflammatory Responses in Metabolic Syndrome Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2012
Registry last updated
Oct 7, 2015

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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