None listed
Conditions
Brief summary
The study aims to reduce circulating blood lipids (fats) and inflammation, two key modifiable risk factors of dyslipidaemia; a major contributor to heart disease. Plant sterols and curcumin are potent cholesterol-lowering and anti-inflammatory agents, respectively. We have previously investigated this novel combination as dietary supplements and now pose the development of a functional food containing both ingredients. We hypothesis that the functional food containing plant sterols and curcumin will be an effective delivery mode for both bioactives, have enhanced compliance and be effective for lowering circulating blood lipids and inflammatory markers in individuals with high cholesterol.
Interventions
The effects of dietary supplementation with a bread enriched with 2.5g of phytosterols with or without 228mg curcumin each day. This randomised control trial is a 2x2 factorial placebo-controlled design.
Hypercholesterolaemic individuals will be randomly assigned to one of the following treatment arms for 4 weeks:
Arm 1: Placebo: x2 slices/day of white bread containing no Phytosterols and no Curcumin.
Arm 2: PS: x2 slices/day of white bread containing 2.5g Phytosterols and 0mg Curcumin.
Arm 3:
The effects of dietary supplementation with a bread enriched with 2.5g of phytosterols with or without 228mg curcumin each day. This randomised control trial is a 2x2 factorial placebo-controlled design. Hypercholesterolaemic individuals will be randomly assigned to one of the following treatment arms for 4 weeks: Arm 1: Placebo: x2 slices/day of white bread containing no Phytosterols and no Curcumin. Arm 2: PS: x2 slices/day of white bread containing 2.5g Phytosterols and 0mg Curcumin. Arm 3: CC: x2 slices/day of white bread containing 0g Phytosterols and 228mg Curcumin. Arm 4: PS-CC: x2 slices/day of white bread containing 2.5g Phytosterols and 228mg Curcumin. *Phytosterols are delivered as Vegapure 67 WDP and Curcumin as Meriva Curcuma Phospholipid Complex powder The bread will be manufactured and packaged by a bread manufacturing company. Participants will be instructed on how to consume the bread (as part of their habitual diet) at their initial baseline visit to the research clinic. The bread is to be consumed as two slices together in the one meal, preferably at breakfast time each day. To assess compliance: 1. Participants will be asked to record their daily consumption of bread in a standardised log provided to them. 2. Participants will be asked to return all bread bags/packets as well as any remaining or uneaten bread slices.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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 e.g. gluten, wheat * History of gastric ulcers, lung and respiratory diseases * History of severe neurological diseases or seizures * BMI greater than 40
Outcome results
None listed