Polyphenols Absorption ProfileNCT02116816
Absorption Profiles of Three Polyphenol Preparations With and Without Pollen Shell Covering
A study testing Polyphenol in people with Polyphenols Absorption Profile, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells. For this purpose 12 healthy volunteers were recruited. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyphenols Absorption Profile
- What is being tested?
- Polyphenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to May 2015
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female subjects between the age of 18-65 who can speak and understand English
- No concomitant medication including herbal medicines and food supplements
- No concomitant disease processes
- Body Mass Index 21- 29kg/m2
- Systolic blood pressure ≤150 mm Hg and diastolic pressure <90 mm Hg
- Subjects who have given informed consent
Who cannot join
- Patients not wishing to allow disclosure to their GPs.
- Concomitant medication including herbal medicines and food supplements
- Concomitant disease processes
- History of drug/alcohol abuse or Alcohol intake within 24 hours of dosing visit (visits 2-4)
- Body Mass Index <21 and > 29kg/m2
- Systolic blood pressure >150 mm Hg and or a diastolic pressure>90 mm Hg
Show all 11Show fewer
- Unable to tolerate polyphenol products or adhere to low polyphenol diet
- Vegetarian
- Subjects not willing or able to fast until 12 noon (a total of 14 hours).
- Pregnant females or planning to conceive in the next 3 months.
- Participation in any other study currently or in the last three months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Michael White Centre for Diabetes and Endocrinology
Hull, East Yorkshire, HU3 2RW
About this study
Official title: Investigation Into Polyphenol Absorption Profiles
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells. For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
Read the detailed description
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells (pollen shells have been shown to enhance lipid molecule absorption). For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
- Conditions
- Polyphenols Absorption Profile
- Being tested
- Polyphenol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyphenolDietary supplement
Polyphenol
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol | Experimental | Polyphenol preparations Receives: Dietary Supplement: Polyphenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Absorption Curve for each polyphenol preparation
Blood samples will be withdrawn 6 times over an 8 hour period: baseline, then 30 minutes, 1 hour, 2 hours, 4 hours and 8 hours after ingestion of each polyphenol supplement (total 3 supplements)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyphenols Absorption ProfileStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Thozhukat Sathyapalan, MBBS FRCP MD, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116816
- Sponsor's protocol ID
- Protocol Version 2
- Status last verified
- Jul 2019
- First submitted
- 15 Apr 2014
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into Polyphenol Absorption Profiles
- ClinicalTrials.gov ID
- NCT02116816
- Acronym / sponsor ID
- Protocol Version 2
- Conditions
- Polyphenols Absorption Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Apr 2014 (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.
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells. For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
Detailed description
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells (pollen shells have been shown to enhance lipid molecule absorption). For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyphenol | Experimental | Dietary Supplement: PolyphenolPolyphenol preparations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female subjects between the age of 18-65 who can speak and understand English
- No concomitant medication including herbal medicines and food supplements
- No concomitant disease processes
- Body Mass Index 21- 29kg/m2
- Systolic blood pressure ≤150 mm Hg and diastolic pressure <90 mm Hg
Key exclusion criteria (11 listed)
- Patients not wishing to allow disclosure to their GPs.
- Concomitant medication including herbal medicines and food supplements
- Concomitant disease processes
- History of drug/alcohol abuse or Alcohol intake within 24 hours of dosing visit (visits 2-4)
- Body Mass Index <21 and > 29kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyphenolPolyphenol | Dietary supplement | Polyphenol |
Primary outcome
Area Under the Absorption Curve for each polyphenol preparation
Time frame: 8 hours
Blood samples will be withdrawn 6 times over an 8 hour period: baseline, then 30 minutes, 1 hour, 2 hours, 4 hours and 8 hours after ingestion of each polyphenol supplement (total 3 supplements)
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 16 Jul 2019.
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Enrolling by invitation
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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.
Thozhukat Sathyapalan, MBBS FRCP MD principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol in people with Polyphenols Absorption Profile, run by Hull University Teaching Hospitals NHS Trust 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 6 inclusion and 11 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 16 Jul 2019. 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?
Area Under the Absorption Curve for each polyphenol preparation (time frame: 8 hours). 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 16 Jul 2019.