Cardiovascular DiseaseNCT01199549
Bioavailability Study of Different Dietary Antioxidants in Volunteers
An observational study of Cardiovascular Disease, run by Cambridge Theranostics Ltd at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and mortality in adults worldwide. While diet and increased physical activity constitute the primary preventive health approach, the role of plant-based bioactive compounds has attracted much attention due to their unique… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Cambridgeshire
Who may be able to join
- Healthy, Caucasian male and female subjects 20 - 80.
- Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method).
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the "normal ranges" for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
- Normal vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study.
- Willingness to undergo a pre-study physical examination and laboratory investigations.
- Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
- Non-smokers, mild to moderate smokers (≤ 10 cigarettes daily).
Who cannot join
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- History of or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
- Participation in another study with an experimental drug within 4 weeks before the first administration of study medication.
- A major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity to the study product or any related products.
- History of bronchial asthma.
Show all 19Show fewer
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Donation or loss of blood equal to or exceeding 500 ml during the 8 weeks before the first administration of study medication or donation or loss blood from 250 to 500 ml in the 6 weeks before administration of study medication or donation or loss of blood up to 250 ml in the 4 weeks before administration of study medication.
- Resting heart rate of > 100 beats per minute or < 45 beats per minute during the screening period, either supine or standing.
- Positive testing for HIV and hepatitis B antigens.
- History of epilepsy
- Adverse events occurring in the pre-exposure phase, judged as "severe" by the principal investigator.
- Difficulty fasting or consuming the standard meals.
- Do not tolerate vein puncture.
- On a special diet within 4 weeks prior to drug administration (e. g. liquid, protein, raw food diet).
- Drug addiction requiring treatment in the past 12 months.
- Do not agree to fully participate in wash-out period and exclude from the diet the recommended food within 4 weeks before the study start and during the study.
- Tomato intolerants
- Milk intolerants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Babraham Research Campus
Cambridge, Cambridgeshire, CB22 3AT
About this study
Official title: Phase 1 Bioavailability Study of Different Dietary Antioxidants in Volunteers
Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and mortality in adults worldwide. While diet and increased physical activity constitute the primary preventive health approach, the role of plant-based bioactive compounds has attracted much attention due to their unique cardio-protective benefits. Several epidemiological studies suggest that dietary patterns characterized by relatively high intake of fruits and vegetables are significantly associated with reduced risks of coronary heart disease and stroke.
Dietary bioactive compounds are potent anti-oxidants and anti-inflammatory agents, thereby counteracting oxidative damage and inflammation, which underlie the pathogenesis of CVD.
Read more
However, this area is really lacking of a good set of chemistry, bioavailability and efficacy data that is vital for nutrition researchers and doctors to emphasize their role in the prevention and treatment of clinical outcomes at different stage of CVD, and dissemination of this information to the general public.
Cambridge Theranostics has focused its efforts on developing products that can prevent the damaging oxidation of lipoproteins that leads to heart attacks and stroke, and on understanding the cause of that damage.
Extensive literature shows that Lycopene, Resveratrol and Soy Isoflavones are key ingredients in diets that long been known to reduce the risk of heart attack and stroke. However, they are normally poorly absorbed (not 'bioavailable'). The investigators unique production process presents Lycopene, Soy Isoflavones and Resveratrol to the body in a form that it can easily absorb and use.
The aim of the current study is to perform and compare bioavailability and absorption of those three different dietary antioxidants and their combinations. The study is funded by Cambridge Theranostics and will be done on healthy volunteers of various ages with 30 people in each product group. It will be conducted on the primacies of Cambridge Theranostics in Babraham Research Campus. And managed by the team of experienced professionals employed by Cambridge Theranostics. The study will last about 12 months including recruitment process, screening process, periodical blood samples collection and examination and statistical analyses at the end.
Read the detailed description
90 volunteers, who fulfill the inclusion criteria, do not meet any of the exclusion criteria, who have given written informed consent will be entered into the study. Lab assays and statistical analysis of the data will be performed on all plasma samples of those subjects who complete the study according to the study protocol or who partially complete the study with evaluable data. Subjects will be recruited from the subject pool of the CTL database.
The study will be performed as a daily for 8 weeks dose, open label, three arms study with 90 subjects.
The study will consist of three groups with one treatment period in each, with a wash-out period of 4 weeks prior the study.
All evaluable data are supposed to be used for the safety evaluation. The subjects will be taking products with a main meal daily. At certain time points (T0 - before study, T1 - 1 week of treatment, T2 - 2 weeks of treatment, T3 - 3 weeks of treatment, T4 - 4 weeks of treatment, T8 - 8 weeks of treatment) after an overnight fasting of about 11 hours the subjects will be invited to the lab for a blood sample collection. Blood samples for the analysis of serum concentrations of Lycopene, Resveatrol and Soy Isoflvones shall be drawn. Two aliquots of each sample will be prepared. One aliquot of each frozen serum sample will be shipped to analytical lab for bioanalysis of Lycopene, Resveatrol and Soy Isoflvones. Other aliquots will be retained at the CTL's lab. A total of 7 blood samples will be collected before and during product intake.
Analytical laboratory of Institute of Food Research, Norwich, will perform measurements of concentration of Lycopene, Resveatrol and Soy Isoflvones using a validated LC-MS/MS method. Calculations of the pharmacokinetic parameters and the assessment of bioavailability will be carried out for all products by CTL. The final report will include all aspects concerning the clinical part of the study, bioanalysis, statistics and discussion of obtained data as well as the legal and ethical requirements.
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lycopene group | Mixed age and gender group of healthy volunteers for testing bio-availability of Lycopene containing supplement | |
| Resveratrol group | Mixed age and gender group of healthy volunteers for testing bio-availability of Resveratrol containing supplement | |
| Laflavon group | Mixed age and gender group of healthy volunteers for testing bio-availability of Soy Isoflavones containing supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt - Area under the serum concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [t(last)]
Measured: 8 weeks
AUC∞ - Area under the serum concentration-time curve from the time point [t=0] to infinity [∞]
Measured: 8 weeks
Cmax - Maximum serum concentration
Measured: 8 weeks
Secondary outcomes (5)
tmax - Time of maximum serum concentration
Measured: 8 weeks
t½ - Elimination half life
AUC(last)-∞ - Difference between AUC∞and AUCt expressed as percentage value
AUCt/AUC∞ - calculated as quotient of AUCt and AUC∞
f = Cmax/ AUCt (indication of rate of absorption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Theranostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199549
- Sponsor's protocol ID
- DAO09C01
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Bioavailability Study of Different Dietary Antioxidants in Volunteers
- ClinicalTrials.gov ID
- NCT01199549
- Acronym / sponsor ID
- DAO09C01
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cambridge Theranostics LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and mortality in adults worldwide. While diet and increased physical activity constitute the primary preventive health approach, the role of plant-based bioactive compounds has attracted much attention due to their unique cardio-protective benefits. Several epidemiological studies suggest that dietary patterns characterized by relatively high intake of fruits and vegetables are significantly associated with reduced risks of coronary heart disease and stroke.
Dietary bioactive compounds are potent anti-oxidants and anti-inflammatory agents, thereby counteracting oxidative damage and inflammation, which underlie the pathogenesis of CVD.
However, this area is really lacking of a good set of chemistry, bioavailability and efficacy data that is vital for nutrition researchers and doctors to emphasize their role in the prevention and treatment of clinical outcomes at different stage of CVD, and dissemination of this information to the general public.
Cambridge Theranostics has focused its efforts on developing products that can prevent the damaging oxidation of lipoproteins that leads to heart attacks and stroke, and on understanding the cause of that damage.
Extensive literature shows that Lycopene, Resveratrol and Soy Isoflavones are key ingredients in diets that long been known to reduce the risk of heart attack and stroke. However, they are normally poorly absorbed (not 'bioavailable'). The investigators unique production process presents Lycopene, Soy Isoflavones and Resveratrol to the body in a form that it can easily absorb and use.
The aim of the current study is to perform and compare bioavailability and absorption of those three different dietary antioxidants and their combinations. The study is funded by Cambridge Theranostics and will be done on healthy volunteers of various ages with 30 people in each product group. It will be conducted on the primacies of Cambridge Theranostics in Babraham Research Campus. And managed by the team of experienced professionals employed by Cambridge Theranostics. The study will last about 12 months including recruitment process, screening process, periodical blood samples collection and examination and statistical analyses at the end.
Detailed description
90 volunteers, who fulfill the inclusion criteria, do not meet any of the exclusion criteria, who have given written informed consent will be entered into the study. Lab assays and statistical analysis of the data will be performed on all plasma samples of those subjects who complete the study according to the study protocol or who partially complete the study with evaluable data. Subjects will be recruited from the subject pool of the CTL database.
The study will be performed as a daily for 8 weeks dose, open label, three arms study with 90 subjects.
The study will consist of three groups with one treatment period in each, with a wash-out period of 4 weeks prior the study.
All evaluable data are supposed to be used for the safety evaluation. The subjects will be taking products with a main meal daily. At certain time points (T0 - before study, T1 - 1 week of treatment, T2 - 2 weeks of treatment, T3 - 3 weeks of treatment, T4 - 4 weeks of treatment, T8 - 8 weeks of treatment) after an overnight fasting of about 11 hours the subjects will be invited to the lab for a blood sample collection. Blood samples for the analysis of serum concentrations of Lycopene, Resveatrol and Soy Isoflvones shall be drawn. Two aliquots of each sample will be prepared. One aliquot of each frozen serum sample will be shipped to analytical lab for bioanalysis of Lycopene, Resveatrol and Soy Isoflvones. Other aliquots will be retained at the CTL's lab. A total of 7 blood samples will be collected before and during product intake.
Analytical laboratory of Institute of Food Research, Norwich, will perform measurements of concentration of Lycopene, Resveatrol and Soy Isoflvones using a validated LC-MS/MS method. Calculations of the pharmacokinetic parameters and the assessment of bioavailability will be carried out for all products by CTL. The final report will include all aspects concerning the clinical part of the study, bioanalysis, statistics and discussion of obtained data as well as the legal and ethical requirements.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lycopene group | – | –Mixed age and gender group of healthy volunteers for testing bio-availability of Lycopene containing supplement |
| Resveratrol group | – | –Mixed age and gender group of healthy volunteers for testing bio-availability of Resveratrol containing supplement |
| Laflavon group | – | –Mixed age and gender group of healthy volunteers for testing bio-availability of Soy Isoflavones containing supplement |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Cambridgeshire
Key inclusion criteria (7 listed)
- Healthy, Caucasian male and female subjects 20 - 80.
- Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method).
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the "normal ranges" for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
- Normal vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study.
- Willingness to undergo a pre-study physical examination and laboratory investigations.
Key exclusion criteria (19 listed)
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- History of or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
- Participation in another study with an experimental drug within 4 weeks before the first administration of study medication.
- A major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity to the study product or any related products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUCt - Area under the serum concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [t(last)]
Time frame: 8 weeks
AUC∞ - Area under the serum concentration-time curve from the time point [t=0] to infinity [∞]
Time frame: 8 weeks
Cmax - Maximum serum concentration
Time frame: 8 weeks
5 secondary outcomes
tmax - Time of maximum serum concentration
Time frame: 8 weeks
t½ - Elimination half life
AUC(last)-∞ - Difference between AUC∞and AUCt expressed as percentage value
AUCt/AUC∞ - calculated as quotient of AUCt and AUC∞
f = Cmax/ AUCt (indication of rate of absorption)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Cambridge Theranostics Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt - Area under the serum concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [t(last)] (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2010.