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

Malaysia Palm Oil Board

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Gamma delta TRF

Study type

Interventional

Funder types

Other

Identifiers

NCT01626430

A004/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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