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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]

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

Gastro-Intestinal Health

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Changes in gut microbiota spectrum as measured by genomic sequencing of stool specimens.

Timepoint [1]

Two months (8 weeks) after initiation of the intervention.

Primary outcome [2]

Changes of parameters of biological oxidation in serum (antioxidant capacity, oxidized LDL and malonic dialdehyde levels quantified by serum spectrophotometry).

Timepoint [2]

Two months (8 weeks) after initiation of the intervention.

Secondary outcome [1]

Changes in serum level of lycopene

Timepoint [1]

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]

Changes in serum level of cocoa flavanols

Timepoint [2]

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

Sex

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

2/07/2018

Actual

Date of last participant enrolment

Anticipated

16/07/2018

Actual

Date of last data collection

Anticipated

28/09/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Russian Federation

State/province [1]

Saratov's Region

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Lycotec Ltd

Address [1]

Granta Park, Platinum Bldg,
Cambridge, Cambridgeshire, CB21 6GP

Country [1]

United Kingdom

Funding source category [2]

University

Name [2]

Saratov's State University, Institute of Cardiology

Address [2]

Chernushevskogo 12, 410028 Saratov, Russia

Country [2]

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]

University

Name [1]

Saratov's State University, Institute of Cardiology

Address [1]

Chernushevskogo 12, 410028 Saratov, Russia

Country [1]

Russian Federation

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee of the Institute of Cardiology, Saratov's State University

Ethics committee address [1]

Chernushevskogo 12, 410028 Saratov, Russia

Ethics committee country [1]

Russian Federation

Date submitted for ethics approval [1]

01/02/2018

Approval date [1]

01/03/2018

Ethics approval number [1]

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

Dr Ivan M Petyaev

Address

Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP

Country

United Kingdom

Phone

+44 (0) 1954 212838

Fax

[email protected]

Contact person for public queries

Name

Yuriy K Bashmakov

Address

Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP

Country

United Kingdom

Phone

+44 (0) 1954 212838

Fax

[email protected]

Contact person for scientific queries

Name

Yuriy K Bashmakov

Address

Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP

Country

United Kingdom

Phone

+19729984307

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prebiotic Effect of Lycopene and Dark Chocolate on Gut Microbiome with Systemic Changes in Liver Metabolism, Skeletal Muscles and Skin in Moderately Obese Persons.	2019	https://dx.doi.org/10.1155/2019/4625279

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically