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.

Will short-term supplementation with palm-tocotrienols and palm-carotenes improve endothelial function as measured by brachial artery flow mediated dilation in participants with increased risk of impaired vascular function compared to control?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001041741

Enrollment

Registered

2013-09-18

Start date

2014-06-10

Completion date

2015-06-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to investigate the effects of short term supplementation with either palm-tocotrienol or palm-carotene on blood vessel function and cardiovascular disease risk in participants at risk of impaired vascular function. We hypothesise that supplementation with both palm-tocotrienol and palm-carotene will improve blood vessel function and cardiovascular disease risk factors compared to a control supplement.

Interventions

Participants will consume one of the following two interventions for a duration of 8 weeks: * 500mg/d palm tocotrienols in the form of two palm olein capsules/d to be consumed orally with the main meal. OR * 21mg/d palm carotenes in the form of three palm olein capsules to be consumed orally with the main meal. Compliance will be monitored by counting of returned capsules and by measuring plasma tocotrienol and carotenoid concentrations using HPLC.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

*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

Exclusion criteria

* 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

Outcome results