None listed
Conditions
Brief summary
Newly obtained results suggest and confirm that atherosclerosis development and cardiovascular disease (CVD) develop in tight connection with dietary intake of lipids. High-cholesterol diet with excessive triglyceride content is a mayor risk factor for cardiovascular health. Inclusion of antioxidants containing highly polyunsaturated compounds in the regular diet prevents CVD developments and improves CVD outcomes. Our recent results suggest that incorporation of polyunsaturated hydrocarbons, such as lycopene, into matrix of dietary fats (dairy butter and vegetable oil) reduces intestinal lipid absorption. Lycosome-formulated lycopene-containing dietary fats (L-tug butter and L-tug vegetable oil) may reduce postprandial hyperlipidemia and prevent increases in total triglyceride content and low-density lipoproteins level in blood after ingestion of dietary fat . This hypothesis creates a scientific rational and needs to be tested in the clinical trials conducted in healthy volunteers.
Interventions
Proprietary lycosome formulations of L-tug dairy butter and L-tug vegetable oil containing lycopene embedded into dietary lipid micelles being studied.
Arm 1. Effect of regular dairy butter and regular vegetable oil on serum lipid profile in healthy volunteers. All volunteers in this arm of the study will be randomized and evenly divided into two subgroups to receive orally either 10 g of dairy butter or 10 g of vegetable oil containing no lycopene daily for period of 2 months.
Arm 2. Effect of
Proprietary lycosome formulations of L-tug dairy butter and L-tug vegetable oil containing lycopene embedded into dietary lipid micelles being studied. Arm 1. Effect of regular dairy butter and regular vegetable oil on serum lipid profile in healthy volunteers. All volunteers in this arm of the study will be randomized and evenly divided into two subgroups to receive orally either 10 g of dairy butter or 10 g of vegetable oil containing no lycopene daily for period of 2 months. Arm 2. Effect of lycopene alone on serum lipid profile in healthy volunteers. All volunteers in this arm of the study will be given orally a capsule containing 7 mg of lycopene alone for period of 2 months daily. Arm 3. All volunteers in this arm of the study will be randomized and evenly divided into two subgroups to receive orally either 10 g of lycosome-formulated of diary butter or 10 g of vegetable oil containing 7 mg of lycopene for period of 2 months daily. Serum lipid profile will be evaluated. Duration of the intervention will be 8 weeks. Adherence to the protocol will be controlled by measuring the the lycopene concentration in the serum specimen collected at the end point of the study as well as phone interviews during the trial.
Sponsors
Lycotec Ltd
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
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers with no acute and chronic diseases.
Exclusion criteria
Any acute or chronic disease, regular intake of any prescribed medications and/or dietary supplements as well as participation in other clinical trials.
Outcome results
None listed