Clinical trial NCT01626430: Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome
Official title: Acute Effects of Tocotrienols on Insulinaemic and Inflammatory Responses in Metabolic Syndrome Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Gamma delta TRF
Insulin sensitivity
Postprandial lipaemia
Inflammatory markers
NF-κB
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Malaya
First posted: 2012-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: C-peptide
timeFrame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Secondary outcomes:
measure: Insulin sensitivity (insulin, glucose)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
measure: Non-esterified fatty acid (NEFA)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
measure: Serum triglycerides (TAG)
timeFrame: 0, 60, 120, 180, 240, 300, 360 min
measure: Inflammatory markers (IL-6, IL-1β, TNF-α)
timeFrame: 0, 120, 240, 360 min
measure: PBMC nuclear factor-κappa B (NF-κB)
timeFrame: 0, 240, 360 min
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board (MPOB)
state: Selangor Darul Ehsan
city: Kajang
country: Malaysia
facility: Malaysia Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Dr Teng Kim Tiu, PhD
role: PRINCIPAL_INVESTIGATOR
References: