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Trial registered on ANZCTR


Registration number
ACTRN12618000715279
Ethics application status
Approved
Date submitted
6/04/2018
Date registered
1/05/2018
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Lycosome-Formulated Dark Chocolate and Lycopene on Gut Microbiota and Oxidative Status
Scientific title
Effect of Lycosome-Formulated Dark Chocolate and Lycopene on Gut Microbiota and Oxidative Status in Healthy Volunteers
Secondary ID [1] 294363 0
none
Universal Trial Number (UTN)
U1111-1211-0449
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microbiota
Biological Oxidation
Nutraceuticals
307094 0
Gastro-Intestinal Health 307096 0
Condition category
Condition code
Oral and Gastrointestinal 306207 306207 0 0
Normal oral and gastrointestinal development and function

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 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.
Intervention code [1] 300800 0
Prevention
Comparator / control treatment
The changes in gut microbiota profile and oxidative parameters in the volunteers ingesting lycosome-formulated dark chocolate containing 7 mg lycopene (Arm 3) will be compared to similar values obtained in two major control (comparator) groups which are:
1. Dark Chocolate alone (no addition of lycopene, Arm 1)..
2. Lycopene alone (no addition of dark chocolate, Arm 2).
Control group
Active

Outcomes
Primary outcome [1] 305408 0
Changes in gut microbiota spectrum as measured by genomic sequencing of stool specimens.
Timepoint [1] 305408 0
Two months (8 weeks) after initiation of the intervention.
Primary outcome [2] 305409 0
Changes of parameters of biological oxidation in serum (antioxidant capacity, oxidized LDL and malonic dialdehyde levels quantified by serum spectrophotometry).
Timepoint [2] 305409 0
Two months (8 weeks) after initiation of the intervention.
Secondary outcome [1] 345093 0
Changes in serum level of lycopene
Timepoint [1] 345093 0
Before the trial (baseline verified on day "0" of the intervention),as well as after 4 and 8 weeks of start of interventions
Secondary outcome [2] 345729 0
Changes in serum level of cocoa flavanols
Timepoint [2] 345729 0
Before the trial (baseline verified on day "0" of the intervention),as well as after 4 and 8 weeks of start of interventions

Eligibility
Key inclusion criteria
Healthy volunteers with no acute and chronic diseases.
Minimum age
30 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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 60 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 multi-variable 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
Not yet 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] 10256 0
Russian Federation
State/province [1] 10256 0
Saratov's Region

Funding & Sponsors
Funding source category [1] 299006 0
Commercial sector/Industry
Name [1] 299006 0
Lycotec Ltd
Address [1] 299006 0
Granta Park, Platinum Bldg,
Cambridge, Cambridgeshire, CB21 6GP
Country [1] 299006 0
United Kingdom
Funding source category [2] 299133 0
University
Name [2] 299133 0
Saratov's State University, Institute of Cardiology
Address [2] 299133 0
Chernushevskogo 12, 410028 Saratov, Russia
Country [2] 299133 0
Russian Federation
Primary sponsor type
Commercial sector/Industry
Name
Lycotec Ltd
Address
Granta Park, Platinum Bldg,
Cambridge, Cambridgeshire, CB21 6GP
Country
United Kingdom
Secondary sponsor category [1] 298231 0
University
Name [1] 298231 0
Saratov's State University, Institute of Cardiology
Address [1] 298231 0
Chernushevskogo 12, 410028 Saratov, Russia
Country [1] 298231 0
Russian Federation

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299934 0
Ethical Committee of the Institute of Cardiology, Saratov's State University
Ethics committee address [1] 299934 0
Chernushevskogo 12, 410028 Saratov, Russia
Ethics committee country [1] 299934 0
Russian Federation
Date submitted for ethics approval [1] 299934 0
01/02/2018
Approval date [1] 299934 0
01/03/2018
Ethics approval number [1] 299934 0
SSU 376/89

Summary
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,


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82034 0
Dr Ivan M Petyaev
Address 82034 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP
Country 82034 0
United Kingdom
Phone 82034 0
+44 (0) 1954 212838
Fax 82034 0
Email 82034 0
ykb75035@aol.com
Contact person for public queries
Name 82035 0
Prof Yuriy K Bashmakov
Address 82035 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP
Country 82035 0
United Kingdom
Phone 82035 0
+44 (0) 1954 212838
Fax 82035 0
Email 82035 0
ybash47926@aol.com
Contact person for scientific queries
Name 82036 0
Prof Yuriy K Bashmakov
Address 82036 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP
Country 82036 0
United Kingdom
Phone 82036 0
+19729984307
Fax 82036 0
Email 82036 0
ybash47926@aol.com

No data has been provided for results reporting
Summary results
Not applicable