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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Gamma delta TRF; Dietary Supplement: Placebo

• Registration Number: NCT01626430
• Lead Sponsor: Malaysia Palm Oil Board

Brief Summary

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.

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-04
• Study First Submitted: 2012-06-16
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-22
• Study Completion: 2012-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
200 mg gd-TRF	Gamma delta TRF	-
400 mg gd-TRF	Gamma delta TRF	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
C-peptide	0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Malaysian Palm Oil Board (MPOB); 🇲🇾 Kajang, Selangor Darul Ehsan, Malaysia

Malaysia Palm Oil Board; 🇲🇾 Kajang, Selangor, Malaysia