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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Gamma delta TRF
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg gd-TRF<br> | Dietary Supplement: Gamma delta TRF<br>* 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.<br>|
| Experimental: 400 mg gd-TRF<br> | Dietary Supplement: Gamma delta TRF<br>* 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.<br>|
| Experimental: Placebo<br> | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gamma delta TRF, Insulin sensitivity, Postprandial lipaemia, Inflammatory markers, NF-κB