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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Gamma delta TRF; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • Malaysia Palm Oil Board
  • Selangor Darul Ehsan
    • Kajang, Selangor Darul Ehsan, Malaysia, 43000
      • Malaysian Palm Oil Board (MPOB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
C-peptide	0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min

Secondary Outcome Measures

Outcome Measure	Time Frame
Insulin sensitivity (insulin, glucose)	0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Non-esterified fatty acid (NEFA)	0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Serum triglycerides (TAG)	0, 60, 120, 180, 240, 300, 360 min
Inflammatory markers (IL-6, IL-1β, TNF-α)	0, 120, 240, 360 min
PBMC nuclear factor-κappa B (NF-κB)	0, 240, 360 min

Collaborators and Investigators

• Sponsor: Malaysia Palm Oil Board
• Collaborators: University of Malaya
• Investigators: Principal Investigator: Dr Teng Kim Tiu, PhD, Malaysia Palm Oil Board

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: June 16, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (ESTIMATE): June 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Inflammatory markers; Insulin sensitivity; Postprandial lipaemia; NF-κB; Gamma delta TRF
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: A004/11