An interventional study of 43.3 mg hydrolyzed green coffee extract and 86.6 mg hydrolyzed green coffee extract in Endothelial Dysfunction, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Australia. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Other
This study evaluates effects of different doses of phenolic acids on healthy volunteers.
It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).
Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Placebo
Other: Placebo
hydrolyzed green coffee extract as interventions
Other: 43.3 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
Other: 86.6 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
Other: 173 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Also known as: Phenolic acid
Reconstituted in water and given to subjects
Also known as: Phenolic acid
Reconstituted in water and given to subjects
Also known as: Phenolic acid
Reconstituted in water and given to subjects
Also known as: maltodextrin
Efficacy by oral administration of phenolic acid in improving endothelial function
Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline.
Time frame: 6 hours
AUC(Area Under Curve) of the concentration/time curve
link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Time frame: 6 hours
Tmax
link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Time frame: 6 hours
Elimination half-life
link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Time frame: 6 hours
Blood concentrations in plasma.
Blood concentrations in plasma.
Time frame: 6 hours
To investigate safety of investigational products: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
Time frame: through study completion, an average of 1 year.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Société des Produits Nestlé (SPN) →