An interventional study of Standard meal in Healthy, sponsored by Federico II University. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-12.
Sponsored by Federico II University · Not applicable, Interventional, and Prevention
Randomized placebo-controlled crossover study during which participants undergo two different experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability.
Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants consume the polyphenol-rich drink. After 3 hours they consume a standard meal to evaluate whether the metabolic response may be influenced by polyphenols.
Other: Standard meal
The participants consume the control drink.After 3 hours they consume a standard meal to evaluate the metabolic response after a placebo.
Other: Standard meal
The participants consume the drink, experimental or placebo drink. After 3 hours they consume a standard meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability of polyphenol.
Phenolic metabolites in urine
GCxGC-MS
Time frame: 48 hours
Glucose response
Enzymatic colorimetric methods
Time frame: 8 hours
Inflammation
Multiplex Detection Immunoassays
Time frame: 8 hours
Oxidative stress (urinary isoprostanes)
EIA
Time frame: 8 hours
Triglyceride response
Enzymatic colorimetric methods
Time frame: 8 hours
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Jul 2016. 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.
Federico II University