Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001787279
Ethics application status
Approved
Date submitted
13/10/2018
Date registered
1/11/2018
Date last updated
1/11/2018
Date data sharing statement initially provided
1/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Lycosome Formulations of L-tug Dairy Butter and L-tug Vegetable Oil on Serum Lipid Profile of Healthy Volunteers
Scientific title
Effect of Lycosome Formulations of L-tug Dairy Butter and L-tug Vegetable Oil on Serum Lipid Profile of Healthy Volunteers
Secondary ID [1] 296329 0
none
Universal Trial Number (UTN)
U1111-1222-2450
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 310039 0
Hyperlipidemia 310040 0
Atherosclerosis 310042 0
Condition category
Condition code
Diet and Nutrition 308791 308791 0 0
Obesity
Cardiovascular 308792 308792 0 0
Coronary heart disease
Metabolic and Endocrine 308983 308983 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Proprietary lycosome formulations of L-tug dairy butter and L-tug vegetable oil containing lycopene embedded into dietary lipid micelles being studied.
Arm 1. Effect of regular dairy butter and regular vegetable oil on serum lipid profile in healthy volunteers. All volunteers in this arm of the study will be randomized and evenly divided into two subgroups to receive orally either 10 g of dairy butter or 10 g of vegetable oil containing no lycopene daily for period of 2 months.
Arm 2. Effect of lycopene alone on serum lipid profile 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 randomized and evenly divided into two subgroups to receive orally either 10 g of lycosome-formulated of diary butter or 10 g of vegetable oil containing 7 mg of lycopene for period of 2 months daily. Serum lipid profile will be evaluated.
Duration of the intervention will be 8 weeks. Adherence to the protocol will be controlled by measuring the the lycopene concentration in the serum specimen collected at the end point of the study as well as phone interviews during the trial.
Intervention code [1] 312656 0
Prevention
Comparator / control treatment
The changes in serum lipid profile in the volunteers ingesting lycosome-formulated dairy butter or vegetable oil containing 7 mg lycopene (Arm 3) will be compared to similar values obtained in two major control (comparator) groups which are:
1. Regular dairy butter or vegetable oil (no addition of lycopene, Arm 1)..
2. Lycopene alone (no addition of dietary fats, Arm 2).
Control group
Active

Outcomes
Primary outcome [1] 307777 0
Changes in serum total triglyceride level as measured by spectrophotometry
Timepoint [1] 307777 0
Two months (8 weeks) after initiation of the intervention
Primary outcome [2] 307778 0
Changes in serum low density lipoprotein cholesterol as measured by spectrophotometry
Timepoint [2] 307778 0
Two months (8 weeks) after initiation of the intervention
Secondary outcome [1] 352847 0
Changes in serum concentration of lycopene as measured by chromatography
Timepoint [1] 352847 0
Two months (8 weeks) after initiation of the intervention

Eligibility
Key inclusion criteria
Healthy volunteers with no acute and chronic diseases.
Minimum age
40 Years
Maximum age
60 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 randomization using a randomization table created by computer software (i.e. computerized 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Volunteers from first and third arms of the study as well as personal conducting the study will not be aware if they receive/administer either control diary butter/vegetable oil or lycosome formulated butter/vegetable oil. Volunteers from the second arm of the study as well as personal conducting the study will be informed about chemical identity of nutraceutical (lycopene) which they receive/administer during the course of the study.
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 50 individuals per group/arm with total number of 150 participants will satisfy the statistical requirements for data analysis and test feasibility of the intervention. 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
3/12/2018
Actual
Date of last participant enrolment
Anticipated
28/12/2018
Actual
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 20934 0
Russian Federation
State/province [1] 20934 0
Saratov's Region

Funding & Sponsors
Funding source category [1] 300932 0
Commercial sector/Industry
Name [1] 300932 0
Lycotec Ltd
Country [1] 300932 0
United Kingdom
Funding source category [2] 300933 0
University
Name [2] 300933 0
Saratov's State University, Institute of Cardiology
Country [2] 300933 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] 300503 0
University
Name [1] 300503 0
Saratov's State University, Institute of Cardiology
Address [1] 300503 0
Chernushevskogo 12, 410028 Saratov, Russia
Country [1] 300503 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301700 0
Ethical Committee of the Institute of Cardiology, Saratov's State University
Ethics committee address [1] 301700 0
Chernushevskogo 12, 410028 Saratov, Russia
Ethics committee country [1] 301700 0
Russian Federation
Date submitted for ethics approval [1] 301700 0
03/09/2018
Approval date [1] 301700 0
17/09/2018
Ethics approval number [1] 301700 0
SSU 381/12

Summary
Brief summary
Newly obtained results suggest and confirm that atherosclerosis development and cardiovascular disease (CVD) develop in tight connection with dietary intake of lipids. High-cholesterol diet with excessive triglyceride content is a mayor risk factor for cardiovascular health. Inclusion of antioxidants containing highly polyunsaturated compounds in the regular diet prevents CVD developments and improves CVD outcomes. Our recent results suggest that incorporation of polyunsaturated hydrocarbons, such as lycopene, into matrix of dietary fats (dairy butter and vegetable oil) reduces intestinal lipid absorption. Lycosome-formulated lycopene-containing dietary fats (L-tug butter and L-tug vegetable oil) may reduce postprandial hyperlipidemia and prevent increases in total triglyceride content and low-density lipoproteins level in blood after ingestion of dietary fat . This hypothesis creates a scientific rational and needs to be tested in the clinical trials conducted in healthy volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53946 0
Dr Ivan M Petyaev
Address 53946 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP
Country 53946 0
United Kingdom
Phone 53946 0
+447921363740
Fax 53946 0
Email 53946 0
[email protected]
Contact person for public queries
Name 53947 0
Prof Yuriy Bashmakov
Address 53947 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP
Country 53947 0
United Kingdom
Phone 53947 0
+447921363740
Fax 53947 0
Email 53947 0
[email protected]
Contact person for scientific queries
Name 53948 0
Prof Yuriy Bashmakov
Address 53948 0
Lycotec Ltd ,Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, United Kingdom, CB21 6GP
Country 53948 0
United Kingdom
Phone 53948 0
+447921363740
Fax 53948 0
Email 53948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participants data underlying published results only will be available for sharing (including age, gender, biochemistry and statistical results).
When will data be available (start and end dates)?
The data will available 3 months after and ending 5 years following main results publication.
Available to whom?
The data sharing will be performed on case-by case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
The results will be available for meta-analyses.
How or where can data be obtained?
The data will be available via link on [email protected] website.


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
No additional documents have been identified.