- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02116816
Absorption Profiles of Three Polyphenol Preparations With and Without Pollen Shell Covering
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
East Yorkshire
-
Hull, East Yorkshire, Storbritannien, HU3 2RW
- Michael White Centre for Diabetes and Endocrinology
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Polyphenol
Polyphenol preparations
|
Polyphenol
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Area Under the Absorption Curve for each polyphenol preparation
Tidsram: 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)
|
8 hours
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Thozhukat Sathyapalan, MBBS FRCP MD, University of Hull
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Protocol Version 2
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