The effects of grape seed extract intake on health

Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Ten healthy volunteers will be enrolled and randomized by block randomization to consume two capsules per day (one in the morning and one in the evening) of Vitis vinifera extract (300 mg oligomeric procyanidins) or placebo (dicalcium phosphate, cellulose, silicon dioxide, magnesium salts of fatty acids, titanium dioxide). Each treatment will be 7 days and separated by at least a 1‐week wash‐out period. CONDITION: Metabolism and biological activity of oligomeric procyanidins ; Not Applicable PRIMARY OUTCOME: Urinary excretion of oligomeric proanthocyanidin‐derived human phenyl‐?‐valerolactone metabolite from Vitis vinifera, measured using high‐resolution mass spectrometry techniques at baseline and at 1, 2, 4, 6, 10, 12, 14, 24 and 48 hours after the intervention and reported as absolute urinary concentration (nmoles/ml) SECONDARY OUTCOME: ; 1. Lipidomic, proteomic and metabolomic status measured by using omics approaches (e.g., proteomic, lipidomic, metabolomic) in the buffy coat at baseline, after 2 hours, and 7 days post‐intervention. Values will be reported semi‐quantitatively as fold‐change.; 2. Levels of DNA damage in the buffy coat measured by comet assay at baseline, after 2 hours and 7 days post intervention; 3. Levels of 8‐hydroxy‐2'‐deoxyguanosine (8‐OHdG) in plasma and urine measured using ELISA kit at baseline, after 2 hours and 7 days post intervention; INCLUSION CRITERIA: 1. Women and men 2. Aged 18‐40 years 3. BMI 18‐25 kg/m² 4. Healthy 5. No smokers
Epistemonikos ID: e13e41ba0781b9979f60a9e6a26abb18645f1ef8
First added on: Aug 25, 2024