None listed
Conditions
Brief summary
Emerging body of scientific evidence suggests that gut microbiota and biological oxidation are two keystone determinants of human health and disease. Gut microbiota and free radical systems are implemented in the development of cardiovascular disease, nutritional disorders and neurological abnormalities. Our preliminary results reveal that biologically active compounds from cocoa beans as well as lycopene, an antioxidant from tomato and other plants, may have significant impact on gut microbiota spectrum and processes of biological oxidation controlling thereby predisposition and initiation of cardiovascular disease. Lycosome formulation of dark chocolate containing lycopene is shown in our previous work to have increased bioavailability of cocoa flavanols and lycopene. It creates a scientific rational to study the effect of lycopene-containing dark chocolate on microbiota spectrum and activity of biological oxidation in healthy volunteers,
Interventions
A proprietary dark chocolate formulation (L-tug dark chocolate) containing lycopene), a carotenoid compound embedded into cocoa butter micelles being studied.
Arm 1. Effect of dark chocolate alone on parameters of gut microbiota and oxidative stress in healthy volunteers. All volunteers in this arm of the study will be given orally a 10 gr of dark chocolate with no lycopene added daily for period of 2 months.
Arm 2. Effect of lycopene alone on parameters of gut microbiota and oxidative stress in
A proprietary dark chocolate formulation (L-tug dark chocolate) containing lycopene), a carotenoid compound embedded into cocoa butter micelles being studied. Arm 1. Effect of dark chocolate alone on parameters of gut microbiota and oxidative stress in healthy volunteers. All volunteers in this arm of the study will be given orally a 10 gr of dark chocolate with no lycopene added daily for period of 2 months. Arm 2. Effect of lycopene alone on parameters of gut microbiota and oxidative stress 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 given orally a 10 gr of lycosome-formulated dark chocolate containing 7 mg of lycopene added for period of 2 months daily. Duration of the intervention will be 8 weeks. Adherence to the protocol will be controlled by measuring the cocoa flavanols concentration and lycopene in the plasma specimens 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, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 50 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