NCT01626430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

June 16, 2012

Last Update Submit

October 5, 2015

Conditions

Metabolic Syndrome

Keywords

Gamma delta TRFInsulin sensitivityPostprandial lipaemiaInflammatory markersNF-κB

Outcome Measures

Primary Outcomes (1)

  • C-peptide

    0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min

Secondary Outcomes (5)

  • 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

Study Arms (3)

200 mg gd-TRF

EXPERIMENTAL
Dietary Supplement: Gamma delta TRF

400 mg gd-TRF

EXPERIMENTAL
Dietary Supplement: Gamma delta TRF

Placebo

EXPERIMENTAL
Dietary Supplement: Placebo

Interventions

Gamma delta TRFDIETARY_SUPPLEMENT

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.

200 mg gd-TRF400 mg gd-TRF
PlaceboDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Malaysia Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

Malaysian Palm Oil Board (MPOB)

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dr Teng Kim Tiu, PhD

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2012

First Posted

June 22, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

MY(2)