Plant sterols and Curcumin for the Prevention of Cardiovascular Disease

Not Applicable

Completed

• Conditions: Hypercholesterolaemia; Inflammation; Cardiovascular disease; Cardiovascular - Other cardiovascular diseases; Diet and Nutrition - Other diet and nutrition disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12615000956505
• Lead Sponsor: niversity of Newcastle

Brief Summary

This research project aimed to investigate if combined dietary supplementation with plant sterols (PS) and curcumin (CC) reduces blood cholesterol and to a larger extent than either of the treatments alone. Cardiovascular disease (CVD) remains the leading cause of death globally. It is characterised by a vast collection of risk factors that can be modified and not-modified. Abnormal blood cholesterol/fats levels are a major modifiable risk factor. In addition, chronic inflammation goes hand-in-hand with elevated cholesterol to initiate atherosclerosis. More effective treatment/management strategies are required to prevent CVD. This was trialled in adults who had elevated blood cholesterol but were not medicated or taking supplements for their cholesterol, did not have any other chronic diseases, were otherwise healthy and free-living in the community. Participants were to consume the study products daily as part of their habitual diet and lifestyle over 4 weeks. PS-alone and PS+CC significantly reduced fasting total cholesterol, LDL-cholesterol and total cholesterol-to-HDL-cholesterol ratio in hypercholesterolaemic adults in 4 weeks in a randomised, placebo-controlled trial. Concurrent supplementation with PS and CC exhibited enhanced hypocholesterolaemic effects compared to either treatment administered alone. Implications include the development of a novel functional food containing both bioactives, long-term studies and larger samples to further substantiate our findings.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-11
• Study Completion: 2016-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

* Age: 18-70 years
* Gender: both males and females
* Total cholesterol levels greater than or equal to 5.5mmol/L (after a 10 hour fast)

Exclusion Criteria

* Pregnant or lactating
* History of cardiovascular events (e.g. stroke, heart attack, angina, aneurysm, hemorrhage, myocardial infarction etc)
* People with pace maker implants
* Diabetes mellitus
* A chronic inflammatory disease and/or condition (e.g. cancer)
* Hypertension
* Liver or renal disease
* Taking anti-inflammatory medications/supplements (e.g. Aspirin, Atacand, Celebrex)
* Taking hypolipidaemic medications/supplements (e.g. Lipitor, Crestor, Zocor)
* Taking regular dietary supplements known to influence blood lipid levels (e.g. fish oil, fibre, curcumin)
* Already consuming phytosterol-enriched products on a daily and/or regular basis (approximately 4 days/week)
* Strong allergies/intolerance/sensitivities or food aversions to the foods involved in this study
* History of gastric ulcers, lung and respiratory diseases
* History of severe neurological diseases or seizures
* BMI greater than 40

Study & Design

• Study Type: Interventional
• Study Design: Not specified