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

This study is currently recruiting participants.
Verified June 2012 by Malaysia Palm Oil Board
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01626430
First received: June 16, 2012
Last updated: June 20, 2012
Last verified: June 2012

June 16, 2012
June 20, 2012
January 2012
April 2012   (final data collection date for primary outcome measure)
C-peptide [ Time Frame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01626430 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity (insulin, glucose) [ Time Frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ] [ Designated as safety issue: No ]
  • Non-esterified fatty acid (NEFA) [ Time Frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ] [ Designated as safety issue: No ]
  • Serum triglycerides (TAG) [ Time Frame: 0, 60, 120, 180, 240, 300, 360 min ] [ Designated as safety issue: No ]
  • Inflammatory markers (IL-6, IL-1β, TNF-α) [ Time Frame: 0, 120, 240, 360 min ] [ Designated as safety issue: No ]
  • PBMC nuclear factor-κappa B (NF-κB) [ Time Frame: 0, 240, 360 min ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Acute Effects of Supplementation of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome
The Acute Effects of Supplementation 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Metabolic Syndrome
  • Dietary Supplement: Gamma delta TRF
    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.
  • Dietary Supplement: Placebo
    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.
  • Experimental: 200 mg gd-TRF
    Intervention: Dietary Supplement: Gamma delta TRF
  • Experimental: 400 mg gd-TRF
    Intervention: Dietary Supplement: Gamma delta TRF
  • Experimental: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact: Che Hui Ling +6012-802 0005 huiling0729@gmail.com
Contact: Dr Teng Kim Tiu, PhD +603-8769 4400 ext 4598 kt.teng@gmail.com
Malaysia
 
NCT01626430
A004/11
Yes
Malaysia Palm Oil Board
Malaysia Palm Oil Board
University of Malaya
Principal Investigator: Dr Teng Kim Tiu, PhD Malaysian Palm Oil Board
Malaysia Palm Oil Board
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP