Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Gamma delta TRF
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Gamma delta TRF, Insulin sensitivity, Postprandial lipaemia, Inflammatory markers, NF-κB
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
Sites / Locations
- Malaysian Palm Oil Board (MPOB)
- Malaysia Palm Oil Board
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
200 mg gd-TRF
400 mg gd-TRF
Placebo
Arm Description
Outcomes
Primary Outcome Measures
C-peptide
Secondary Outcome Measures
Insulin sensitivity (insulin, glucose)
Non-esterified fatty acid (NEFA)
Serum triglycerides (TAG)
Inflammatory markers (IL-6, IL-1β, TNF-α)
PBMC nuclear factor-κappa B (NF-κB)
Full Information
NCT ID
NCT01626430
First Posted
June 16, 2012
Last Updated
October 5, 2015
Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT01626430
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Gamma delta TRF, Insulin sensitivity, Postprandial lipaemia, Inflammatory markers, NF-κB
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
200 mg gd-TRF
Arm Type
Experimental
Arm Title
400 mg gd-TRF
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Gamma delta TRF
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
C-peptide
Time Frame
0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Secondary Outcome Measure Information:
Title
Insulin sensitivity (insulin, glucose)
Time Frame
0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Title
Non-esterified fatty acid (NEFA)
Time Frame
0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Title
Serum triglycerides (TAG)
Time Frame
0, 60, 120, 180, 240, 300, 360 min
Title
Inflammatory markers (IL-6, IL-1β, TNF-α)
Time Frame
0, 120, 240, 360 min
Title
PBMC nuclear factor-κappa B (NF-κB)
Time Frame
0, 240, 360 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Teng Kim Tiu, PhD
Organizational Affiliation
Malaysia Palm Oil Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysian Palm Oil Board (MPOB)
City
Kajang
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Malaysia Palm Oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome
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