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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01626430

Enrollment

Registered

2012-06-22

Start date

2012-01-31

Completion date

2012-12-31

Last updated

2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Gamma delta TRF, Insulin sensitivity, Postprandial lipaemia, Inflammatory markers, NF-κB

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.

Interventions

DIETARY_SUPPLEMENTGamma 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.

DIETARY_SUPPLEMENTPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026