An Early Phase 1 interventional study of Vineatrol 30 native powder and Vineatrol 30 micelles in Safety After Oral Intake and Pharmacokinetics After Oral Intake, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-03.
Sponsored by University of Hohenheim · Early Phase 1, Interventional, and Basic science
To enhance the oral bioavailability of the antioxidants trans-resveratrol and trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was incorporated into micelles. A single dose, single blind, two arms crossover trial was conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and compared between formulations. Tolerability of the dose was also controlled by safety parameters in plasma.
University of Hohenheim is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy Volunteers with blood chemistry values within normal ranges
Age: 18-35 years
BMI: 19-25 kg/m2
Exclusion Criteria:
Pregnancy or lactation
Alcohol and/or drug abuse
Use of dietary supplements or any medications, except contraceptives
Any known malignant, metabolic and endocrine diseases
Previous cardiac infarction
Dementia
Participation in a clinical trial within the past 6 weeks prior to recruitment
Smoking
Physical activity of more than 5 h/wk
500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin
Dietary Supplement: Vineatrol 30 native powder
500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin
Dietary Supplement: Vineatrol 30 micelles
Mean area under the curve (AUC) of plasma concentration vs. time of total trans-resveratrol [nmol/L*h]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total trans-epsilon-viniferin [nmol/L*h]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total trans-resveratrol [nmol/L]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total trans-epsilon-viniferin [nmol/L]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total trans-resveratrol [h]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total trans-epsilon-viniferin [h]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Cumulative urinary excretion of total trans-resveratrol [nmol/g creatinine]
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Cumulative urinary excretion of total trans-epsilon-viniferin [nmol/g creatinine]
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Serum aspartate transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum bilirubin
Time frame: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Time frame: 0, 4, 24h post-dose
Serum cystatin C [mg/mL]
Time frame: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Time frame: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Time frame: 0, 24h post-dose
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Hohenheim