None listed
Conditions
Brief summary
Dark chocolate flavanols and lycopene are potent nutraceuticals with variety of effects on cardiovascular system. L-tug, a novel formulation of dark chocolate with an improved bioavailability of cocoa flavanols, has been shown in preliminary studies to reduce both the systemic blood pressure and serum lipids. The primary purpose of the trial is to verify the reproducibility and statistical significance of blood pressure and serum lipid reductions in suitable cohorts of 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 L-tug dark chocolate on blood pressure in pre-hypertensive volunteers.
Arm 2. Effect of L-tug dark chocolate on lipid profile in hyperlipidemic volunteers.
In both arms of the trial volunteers will be given once daily10 g of L-tug dark chocolate bar containing 7 mg of lycopene embedded into its matrix. Duration of the i
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 L-tug dark chocolate on blood pressure in pre-hypertensive volunteers. Arm 2. Effect of L-tug dark chocolate on lipid profile in hyperlipidemic volunteers. In both arms of the trial volunteers will be given once daily10 g of L-tug dark chocolate bar containing 7 mg of lycopene embedded into its matrix. Duration of the intervention will be 4 weeks. Adherence to the protocol will be controlled by measuring the cocoa flavanols concentration in the plasma specimens collected at the end point of the study.
Sponsors
Lycotec Ltd, United Kingdom
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Arm 1. Increased systemiic blood pressure in pre-hypertension range (systolic pressure 120-139 mmHg, diastolic - 80-89 mmHg) Arm 2. Moderate increase in serum total cholesterol (200-239 mg/dl)
Exclusion criteria
food allergies, obesity, alcoholism
Outcome results
None listed