Circulatory System Mental and Behavioural Disorders Cardiology
Conditions
Interventions
Fermented red Rooibos capsules
Placebo capsules containing microcrystalline maltodextrin
Green Rooibos
Sponsors
CPUT Prestigious Funding Programme from the Office of the DVC
The South African Rooibos Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will select adults (male and female) from the Western Cape region between 30 – 80 years old with any two or more of the following modifiable risk factors for coronary heart disease as described by the American Heart Association (2002): 1) hyperlipidaemia (raised cholesterol - >5.5 to 7.5 mmol/L and triglycerides - >1.7 to 25 to 38 kg/m2 BMI), 4) physical inactive or 5) following a atherogenic diet (estimated by the fat intake questionnaire) high in saturated fat and cholesterol. Only participants not requiring any chronic medication for these mentioned medical conditions will be included.
Exclusion criteria
Exclusion criteria: Exclusion criteria include known renal, hepatic, endocrine or gastrointestinal disorders, undesirable alcohol consumption (>2drinks per day), unusual dietary habits (e.g. vegetarian or vegan diets), use of any chronic oral medication, antioxidant supplements, aspirin or any other drug with established antioxidant properties, pregnancy (actual/intended) and/or lactating women. All potential participants who were successful in the pre-screening round (which will be done by completing a health, demographic and abbreviated flavonoid questionnaire) will be screened for the following biochemical parameters: serum glucose & total cholesterol, as well as measurement of their blood pressure to determine their eligibility to participate in the study. The final selection of participants will be made in consultation with the study doctor. Qualified phlebotomists and/or nursing sisters will be recruited for the taking of fasting (8 hour overnight)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the relative safety of a chronic intake of fermented and green rooibos (blood analyses assessing liver function and kidney function are still in progress); the effect of chronic intake of fermented and green rooibos on lipid profiles (blood analyses for total cholesterol, HDL, LDL, triglycerides and blood glucose have recently been completed, however, data and statistical analyses are currently in progress); and analyse the antioxidant capacity of blood samples during baseline and intervention phases (ORAC, FRAP, ABTS, DPPH and TP assays to measure oxidative damage to cell components, redox status and inflammatory status of participants have been completed, with data and statistical analyses currently in progress). | — |
Secondary
| Measure | Time frame |
|---|---|
| Genetic profiling of the study participants with inclusion of three genes implicated in CVD (genotyping of six functional gene variants have been completed); as well as assessing whether fermented and green rooibos can influence or alter certain endogenous metabolites implicated in CVD pathways (blood plasma samples have been sent to collaborators and sample extraction and preparation completed, with LC-MS/MS analyses of the samples currently in progress); and whether the consumption of the two rooibos herbal teas resulted in any improvement of in cardiovascular function by comparing the echocardiography findings between the various intervention groups (echocardiography data collection and digitization completed in December 2022, with statistical analyses of data currently in progress). | — |
Countries
South Africa
Contacts
Public ContactNola Tomboer
Research Nurse
Outcome results
None listed