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Trial registered on ANZCTR


Registration number
ACTRN12613000966796
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
30/08/2013
Date last updated
30/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of lycosome-formulated dark chocolate on serum lipid profile and parameters of cardiovascular health
Scientific title
Effect of lycopene-containing lycosome-formulated dark chocolate on lipid profile and parameters of cardiovascular health in pre-hypertensive and hyperlipidemic individuals
Secondary ID [1] 283025 0
nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 289857 0
hyperlipidemia 289903 0
Condition category
Condition code
Cardiovascular 290216 290216 0 0
Other cardiovascular diseases
Alternative and Complementary Medicine 290270 290270 0 0
Other alternative and complementary medicine
Cardiovascular 290319 290319 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287746 0
Other interventions
Comparator / control treatment
L-tug dark chocolate with no lycopene (10 g bar given orally once daily).
Control group
Placebo

Outcomes
Primary outcome [1] 290237 0
reduction in the systemic blood pressure > 4 mmHg as measured by an automatic sphygmomanometer
Timepoint [1] 290237 0
each participant will be evaluated in 2 and 4 weeks from start of the intervention
Primary outcome [2] 290238 0
reduction in serum LDL cholesterol >10 mg/dl
Timepoint [2] 290238 0
each participant will be evaluated in 2 and 4 weeks from the start of intervention
Secondary outcome [1] 304187 0
reduction in serum triglycerides
Timepoint [1] 304187 0
end of the 4th week of the intervention
Secondary outcome [2] 304271 0
improved artherial flow as measured by doppler ultrasound protocol
Timepoint [2] 304271 0
end of the 4th weeks of the intervention

Eligibility
Key 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)
Minimum age
40 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
food allergies, obesity, alcoholism

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Study is designed on an intention-to-treat basis. A pilot trial was performed as validation study for sample size evaluation. It was determined using one-tailed t-test that 80 individuals will satisfy the statistical requirements for data analysis and test feasibility of the intervention compared to the placebo group. Association between trial outcome and specific study arms of the study will be analyzed by multivariable analysis.
Categorical values will be analyzed by Stata 12 and MedCalc software. Continuous variable will be compared using the Mann-Whitney U-test. Linear regression analysis will be performed for both arms of the study. A p-value threshold is set at <0.05 to claim statistical significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5295 0
Russian Federation
State/province [1] 5295 0
Saratov Region
Country [2] 5296 0
United Kingdom
State/province [2] 5296 0
Cambridgeshire

Funding & Sponsors
Funding source category [1] 287788 0
Commercial sector/Industry
Name [1] 287788 0
Lycotec Ltd
Address [1] 287788 0
Granta Park, Platinum Bldg,
Cambridge, Cambridgeshire, CB21 6GP
Country [1] 287788 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Lycotec Ltd, United Kingdom
Address
Granta Park, Platinum Bldg, Cambridge, Cambridgeshire,
United Kingdom, CB21 6GP
Country
United Kingdom
Secondary sponsor category [1] 286518 0
Government body
Name [1] 286518 0
Institute of Cardiology, Saratov, Russian Federation
Address [1] 286518 0
Institute of Cardiology, 12 Chernyshevskogo Str, 410028 Saratov, Russia
Country [1] 286518 0
Russian Federation

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289737 0
Medical Research Ethical Committee, Institute of Cardiology
Ethics committee address [1] 289737 0
Institute of Cardiology, 12 Chernyshevskogo Str, 410028 Saratov, Russia
Ethics committee country [1] 289737 0
Russian Federation
Date submitted for ethics approval [1] 289737 0
05/06/2013
Approval date [1] 289737 0
10/07/2013
Ethics approval number [1] 289737 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42174 0
Dr Ivan Petyaev
Address 42174 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, CB21 6GP
Country 42174 0
United Kingdom
Phone 42174 0
+44 (0) 1954 212838
Fax 42174 0
Email 42174 0
ykb75035@aol.com
Contact person for public queries
Name 42175 0
Dr Ivan Petyaev
Address 42175 0
Lycotec Ltd, Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, CB21 6GP
Country 42175 0
United Kingdom
Phone 42175 0
+44 (0) 1954 212838
Fax 42175 0
Email 42175 0
ykb75035@aol.com
Contact person for scientific queries
Name 42176 0
Dr Yuriy Bashmakov
Address 42176 0
Lycotec Ltd, Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, CB21 6GP
Country 42176 0
United Kingdom
Phone 42176 0
+44 (0) 1954 212838
Fax 42176 0
Email 42176 0
yuriy.bashmakov@lycotec.com

No information has been provided regarding IPD availability
Summary results
No Results