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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626430
• Other study ID #: A004/11
• Status: Completed
• Phase: N/A
• First received: June 16, 2012
• Last updated: October 5, 2015
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Gamma 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.
• Placebo
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.

Locations

Country	Name	City	State
Malaysia	Malaysia Palm Oil Board	Kajang	Selangor
Malaysia	Malaysian Palm Oil Board (MPOB)	Kajang	Selangor Darul Ehsan

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide		0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min	No
Secondary	Insulin sensitivity (insulin, glucose)		0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min	No
Secondary	Non-esterified fatty acid (NEFA)		0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min	No
Secondary	Serum triglycerides (TAG)		0, 60, 120, 180, 240, 300, 360 min	No
Secondary	Inflammatory markers (IL-6, IL-1ß, TNF-a)		0, 120, 240, 360 min	No
Secondary	PBMC nuclear factor-?appa B (NF-?B)		0, 240, 360 min	No