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

• ClinicalTrials.gov Identifier: NCT01626430
• Recruitment Status: Completed
• First Posted: June 22, 2012
• Last Update Posted: October 7, 2015
• Sponsor: Malaysia Palm Oil Board
• Collaborator: University of Malaya
• Information provided by (Responsible Party): Malaysia Palm Oil Board

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Dietary Supplement: Gamma delta TRF; Dietary Supplement: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Acute Effects of Tocotrienols on Insulinaemic and Inflammatory Responses in Metabolic Syndrome Subjects
• Study Start Date: January 2012
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 200 mg gd-TRF	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.
Experimental: 400 mg gd-TRF	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.
Experimental: Placebo	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures :

1. C-peptide [ Time Frame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ]

Secondary Outcome Measures :

1. Insulin sensitivity (insulin, glucose) [ Time Frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ]
2. Non-esterified fatty acid (NEFA) [ Time Frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min ]
3. Serum triglycerides (TAG) [ Time Frame: 0, 60, 120, 180, 240, 300, 360 min ]
4. Inflammatory markers (IL-6, IL-1β, TNF-α) [ Time Frame: 0, 120, 240, 360 min ]
5. PBMC nuclear factor-κappa B (NF-κB) [ Time Frame: 0, 240, 360 min ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Malaysia

Malaysian Palm Oil Board (MPOB)

Kajang, Selangor Darul Ehsan, Malaysia, 43000

Malaysia Palm Oil Board

Kajang, Selangor, Malaysia, 43000

Sponsors and Collaborators

Malaysia Palm Oil Board

University of Malaya

Investigators

• Principal Investigator: Dr Teng Kim Tiu, PhD; Malaysia Palm Oil Board

More Information

• Responsible Party: Malaysia Palm Oil Board
• ClinicalTrials.gov Identifier: NCT01626430
• Other Study ID Numbers: A004/11
• First Posted: June 22, 2012
• Last Update Posted: October 7, 2015
• Last Verified: October 2015

Keywords provided by Malaysia Palm Oil Board:

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

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases