The effects of grape seed extract intake on health

Metabolic profile of a standardized extract of oligomeric procyanidins (PACs) from Vitis vinifera seeds in the urine and plasma of healthy volunteers and application of omic sciences for a better understanding of the biological action

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39867491

Enrollment

Registered

2022-03-03

Start date

2022-03-10

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and biological activity of oligomeric procyanidins Not Applicable

Interventions

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 p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women and men 2. Aged 18-40 years 3. BMI 18-25 kg/m² 4. Healthy 5. No smokers

Exclusion criteria

Exclusion criteria: 1. Smokers 2. Allergy to grape 3. Gastrointestinal disorder 4. Liver and renal disease 5. Antibiotic treatment 5. Use of supplements

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026