The effects of grape seed extract intake on health
| ISRCTN | ISRCTN39867491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39867491 |
- Submission date
- 25/02/2022
- Registration date
- 03/03/2022
- Last edited
- 18/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Grape seeds (Vitis vinifera) are a rich source of oligomeric proanthocyanidins (PAC), a class of polyphenols with potential health-promoting effects. However, these polyphenols are poorly absorbed and reach the large intestine where they are transformed by bacteria. These metabolic products could be responsible for the beneficial effects. The aims of this study are: i) to identify and quantify the main components/metabolites of grape seed in the urine of healthy volunteers; ii) to evaluate the activation of genes involved in the antioxidant and inflammatory response. The results will improve our understanding of the metabolism of PAC and the potential health effects of these components and their metabolic products on the antioxidant response.
Who can participate?
Healthy men and women aged 18-40 years with a normal weight (body mass index 18-25 kg/m²)
What does the study involve?
Participants will be randomly allocated to take two capsules per day of oligomeric proanthocyanidin or placebo (dummy capsules) for 7 days. Blood and urine samples will be collected at the start of the study and after 7 days. After a 1-week break, participants swap to the opposite capsules for 7 days and urine and blood samples are collected again. Body measurements and tests will be carried out at the start of the study.
What are the possible benefits and risks of participating?
Oligomeric proanthocyanidin (PAC) may be broken down and activate the body's defence mechanisms against oxidative stress and inflammation. There are no expected risks.
Where is the study run from?
1. Department of Pharmaceutical Sciences, DiSFARM- Università degli Studi di Milano (Italy)
2. Department of Food, Environmental and Nutritional Sciences, DeFENS-Università degli Studi di Milano (Italy)
When is the study starting and how long is it expected to run for?
September 2021 to November 2022
Who is funding the study?
Distillerie Bonollo S.p.A, Formigine (Italy)
Who is the main contact?
1. Prof. Giancarlo Aldini, Giancarlo.aldini@unimi.it
2. Dr Cristian Del Bo’, cristian.delbo@unimi.it
Contact information
Principal Investigator
University of Milan-Department of Pharmaceutical Sciences
Milano
20133
Italy
 ORCID ID |
0000-0002-2355-6744 |
|---|---|
| Phone | +39 (0)250319296 |
| giancarlo.aldini@unimi.it |
Scientific
Via Luigi Mangiagalli 25
Milan
20133
Italy
| ORCID ID |
0000-0001-7562-377X |
|---|---|
| Phone | +39 (0)250316730 |
| cristian.delbo@unimi.it |
Study information
| Study design | Randomized controlled crossover intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | 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 |
| Study acronym | METAPAC |
| Study objectives | This pilot study aims to test the hypothesis that oligomeric procyanidins from a standardized Vitis vinifera seed extract are absorbed and metabolized, and can induce the activation of genes involved in the antioxidants and anti-inflammatory response. |
| Ethics approval(s) | Approved 15/09/2021, the Ethics Committee of the University of Milan (Via Festa del Perdono 7, 20122, Milano, Italia; +39 (0)2 503.12667; comitato.etico@unimi.it), ref: 94/21 |
| Health condition(s) or problem(s) studied | Metabolism and biological activity of oligomeric procyanidins |
| 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. |
| Intervention type | Supplement |
| Primary outcome measure | Urinary excretion of oligomeric proanthocyanidin-derived human phenyl-γ-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 measures | 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 |
| Overall study start date | 15/09/2021 |
| Completion date | 30/11/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Women and men 2. Aged 18-40 years 3. BMI 18-25 kg/m² 4. Healthy 5. No smokers |
| Key exclusion criteria | 1. Smokers 2. Allergy to grape 3. Gastrointestinal disorder 4. Liver and renal disease 5. Antibiotic treatment 5. Use of supplements |
| Date of first enrolment | 10/03/2022 |
| Date of final enrolment | 30/03/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milano
20133
Italy
Sponsor information
University/education
Via Festa del Perdono, 7
Milano
20122
Italy
| Phone | +39 (0)2 5032 5032 |
|---|---|
| unimi@postecert.it | |
| Website | https://www.unimi.it/it |
"ROR" |
https://ror.org/00wjc7c48 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of study results in high-impact peer-reviewed journals following trial completion. A protocol will be uploaded in the next few months. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from: 1. Prof. Giancarlo Aldini (giancarlo.aldini@unimi.it) 2. Dr Cristian Del Bo' (cristian.delbo@unimi.it) Data are anonymous and consent was obtained from participants. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/12/2023 | 18/12/2023 | Yes | No |
Editorial Notes
18/12/2023: Publication reference added.
15/07/2022: The following changes have been made:
1. The final enrolment number has been added.
2. The overall trial end date has been changed from 01/07/2022 to 30/11/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/09/2022 to 01/05/2023.
28/02/2022: Trial's existence confirmed by the Ethics Committee of the University of Milan.
