Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Dietary Supplement: Gamma delta TRF
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Acute Effects of Supplementation of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • C-peptide [ Time Frame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 mg gd-TRF 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.
Experimental: 400 mg gd-TRF 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.
Experimental: Placebo 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626430

Contacts
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

Locations
Malaysia
Malaysian Palm Oil Board (MPOB) Recruiting
Kajang, Selangor Darul Ehsan, Malaysia, 43000
Contact: Che Hui Ling     +6012-802 0005     huiling0729@gmail.com    
Principal Investigator: Dr Teng Kim Tiu, PhD            
Malaysia Palm Oil Board Recruiting
Kajang, Selangor, Malaysia, 43000
Contact: Che Hui Ling     +6012-802 0005     huiling0729@gmail.com    
Contact: A/P Dr Kanthimathi M. S., PhD     +603-7967 4913 ext 4906     kanthi@um.edu.my    
Principal Investigator: Dr Teng Kim Tiu, PhD            
Sub-Investigator: A/P Dr Kanthimathi M. S., PhD            
Sub-Investigator: Radhika Loganathan, M.Sc            
Sub-Investigator: Prof Dr Yuen Kah Hay, PhD            
Sub-Investigator: Dr Kanga Rani Selvaduray, PhD            
Sub-Investigator: Dr Kalanithi Nesaretnam, PhD            
Sub-Investigator: Dr Alexander Tan Tong Boon, MRCP            
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
Investigators
Principal Investigator: Dr Teng Kim Tiu, PhD Malaysian Palm Oil Board
  More Information

No publications provided

Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01626430     History of Changes
Other Study ID Numbers: A004/11
Study First Received: June 16, 2012
Last Updated: June 20, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by Malaysia Palm Oil Board:
Gamma delta TRF
Insulin sensitivity
Postprandial lipaemia
Inflammatory markers
NF-κB

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Tocotrienols
Vitamin E
Tocopherols
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013