Short term effects of palm-tocotrienols and palm-carotenes on vascular function and cardiovascular disease risk in individuals at increased risk of impaired vascular function.
- Conditions
- Cardiovascular disease riskType 2 diabetesImpaired fasting glucoseAbdominal obesityCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemMetabolic and Endocrine - DiabetesAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12613001041741
- Lead Sponsor
- CSIRO Animal, Food and Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
*Male or female
*Type 2 diabetes (previously diagnosed and taking anti-diabetic medication or HbA1c of 7.0-10.0%) or impaired fasting glucose (fasting plasma glucose of 5.6 mmol/L and greater) or abdominal obesity identified by elevated waist circumference: equal of greater than 102 cm (men); equal or greater than 88 cm (women).
*18-70 years
* BMI: 20-45 kg/m2
* No abnormality of clinical significance on medical history
* No history of coronary artery disease or cardiac (heart) abnormalities
* Type 1 diabetes
* Smoking
* Known proteinuria or current malignancy
* Known kidney, respiratory, gastrointestinal, cardiovascular or peripheral vascular disease
* Known abnormal liver function tests
* Known endocrinopathy unless participants are stable on treatment (have been using thyroxine for at least 3 months prior to study commencement (no changes in type and dose) and have no intention to change during study).
* Pregnancy or lactating
* Participated in regular vigorous physical exercise greater than 1 hour per week or greater than 2x, 30 minute sessions / week during the 3 months prior to the study
* Have taken tocotrienol or carotene supplements during the 3 months prior to study
* Taking supplements known to affect outcome measures (i.e. fish oil, vitamin C) unless supplements are ceased before trial commencement (3 months for fish oil, 2 weeks for vitamin C) or participants are stable on the supplements for at least 3 months prior to study commencement (no changes in type and dose) and have no intention to change during study.
* Use of nitrate medication, non-steroidal anti-inflammatory medication (excluding aspirin)
* Taking oral contraceptives or hormone replacement therapy during the 3 months prior to study
* History of heavy alcohol consumption (> 5 STD drinks/day)
* Volunteer unable to limit alcohol consumption for study duration
* Currently on a weight reducing diet or have an eating disorder
* Unwilling to be randomized to either experimental group
* Extended absences due to travel or other commitments
* Unable to comprehend or cope with study requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endothelial function measured by brachial artery flow mediated dilation[Baseline, 4 weeks, 8 weeks]
- Secondary Outcome Measures
Name Time Method Blood pressure using automated oscillometry<br>[Baseline, 4 weeks, 8 weeks];Glucose metabolism<br>* Insulin and glucose using plama assays<br>* Insulin resistance by calculating HOMA2-IR<br>* HbA1c using HPLC<br>[Baseline, 4 weeks, 8 weeks];Lipid profiles (total cholesterol, HDL-C, LDL-C, triglycerides) using plasma assays[Baseline, 4 weeks, 8 weeks];Plasma inflammatory markers (hs-CRP, IL-6, TNFalpha, adiponectin) using multiplex kits<br>[Baseline, 4 weeks, 8 weeks];Plasma adhesion molecules (ICAM-1, VCAM-1, E-selectin) using multiplex assays<br>[Baseline, 4 weeks, 8 weeks];Endothelium derived fibrinolytic factors:<br>* tPA using plasma assays<br>* PAI-1 using mulitplex assays<br>[Baseline, 4 weeks, 8 weeks];Arterial stiffness using pulse wave velocity and augmentation index[Baseline, 4 weeks, 8 weeks]