DOSE-dependent response of polyphenols from GRAPE extract on polyphenols bioavailability
| ISRCTN | ISRCTN06777936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06777936 |
| Secondary identifying numbers | IRB00003099 |
- Submission date
- 01/07/2014
- Registration date
- 06/08/2014
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Grape pomaces are the solids left behind after the grapes have been pressed to make oils, juice or wine. They are known to be a rich source of polyphenols, chemicals that may be useful in protecting against a number of health problems or as ingredients for developing new interesting products. The effects of these compounds when consumed depend on how well they are absorbed (bioavailability) and also how they react in, and are used by, the body (pharmacokinetics). The aim of this study is to investigate the bioavailability and pharmacokinetics of these polyphenols by giving people different amounts of a grape extract in order to find out the most effective dose.
Who can participate?
Healthy adults aged between 20-40 years, non-smokers, without previous history of cardiovascular disease, liver or kidney disease, homeostatic disorders, any several chronic diseases, high blood pressure or dyslipemia (abnormal amount of fat or cholesterol in the body), grape intolerance or allergic, alcoholism or other toxic abuse.
What does the study involve?
Participants are randomly allocated into one of three treatment (intervention) groups. For intervention 1, participants are given 100 mL of light soda water and 400 mL of water to drink. For intervention 2, they are given 100 mL of grape extract, 100 mL of light soda water and 300 mL of water. For intervention 3, they are given 200 mL of grape extract, 100 mL of light soda water and 200 mL of water. Blood samples are taken at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours and 24 hours after they have had their allotted drink. The first urine of the day before the start of the trial is also collected and then at 0 hours, 0-3 hours, 3-6 hours, 6-12 hours and 12-24 hours the day after they have had their allotted drink. Everyone will participate in all three intervention programmes, but with 3 day rest (wash-out period) in-between, when they are asked not to consume grapes or wine and to follow a polyphenol free diet the day before starting the next treatment.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part in the study and no risks as long as the exclusion criteria are followed.
Where is the study run from?
1. Department of Nutrition and Food Science of the University of Barcelona (Spain)
2. Department of Internal Medicine, Hospital Clinic, Institut of Biomedical Research August Pi i Sunyer (IDIBAPS) (Spain)
3. University of Barcelona (Spain).
When is the study starting and how long is it expected to run for?
January 2014 to May 2014.
Who is funding the study?
1. Ministry of Economy and Competitiveness INNPRONTA (Spain)
2. CIBEROBN (Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición) (Biomedical Research Centre in Physiopathology of Obesity and Nutrition) (Spain)
Main contact
Dr. Rosa Lamuela-Raventós,
lamuela@ub.edu
Contact information
Scientific
Nutrition and Food Science Department
School of Pharmacy
University of Barcelona
Av. Joan XXIII, s/n
Barcelona
08028
Spain
| Phone | +34 (0) 93 403 48 43 |
|---|---|
| lamuela@ub.edu |
Study information
| Study design | Cross-over randomized double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Determining the bioavailability of polyphenols from grape extract, their kinetics in plasma and their presence in urine to optimize the effective dose to observe any effect: a cross-over, randomized and double-blind trial |
| Study acronym | DOSEGRAPE |
| Study objectives | Grapes contain several phenolic compounds, which are known for their health benefits. Hypothesis 1: There is a close relationship between the intake dose and the polyphenols concentration in plasma Hypothesis 2: Consumption of grape extract will produce an improvement in biochemical parameters |
| Ethics approval(s) | Ethics Committee of the University of Barcelona, 10/06/2014, Institutional Review Board IRB00003099 |
| Health condition(s) or problem(s) studied | Concentration of polyphenols in urine and their kinetics in plasma |
| Intervention | Intervention 1: 100 ml of light soda water and 400 ml of water Intervention 2: 100 ml of grape extract, 100 ml of light soda water and 300 ml of water Intervention 3: 200 ml of grape extract, 100 ml of light soda water and 200 ml of water Before each intervention, participants will follow a 3-day washout period, avoiding consuming grape and wine, and on the preceding day will follow a polyphenol-free diet. Co-sponsor details: CIBEROBN (Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición) (Biomedical Research Centre in Physiopathology of Obesity and Nutrition) (Spain) Instituto de Salud Carlos III C/Monforte de Lemos 3-5 Pabellón 11 Planta 0 28029 Madrid Spain gerencia@ciberisciii.es |
| Intervention type | Other |
| Primary outcome measure | Polyphenols will be identified through liquid chromatography coupled to Orbitrap mass spectrometry. Concentrations of polyphenols will be quantified by liquid chromatography coupled to tandem mass spectrometry (LCMS/MS). Polyphenols will be quantified at 0 to 24 hours of each intervention. |
| Secondary outcome measures | Before (0 hours) and after each intervention (6 hours) the following measures were taken: 1. Blood pressure 2. Body weight 3. Waist perimeter 4. Glucose 5. Lipid profile 6. Biomarkers of oxidative stress and systematic inflammation 7. Coagulation factor and vitamin levels |
| Overall study start date | 02/01/2014 |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | Healthy adults (females and males), aged 20-40 years |
| Key exclusion criteria | 1. Previous history of cardiovascular disease (ischemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease) 2. Homeostatic disorders 3. Any several chronic diseases 4. Hypertension or dyslipidemia 5. Grape intolerance or allergic 6. Smoking subjects 7. Alcoholism 8. Other toxic abuse |
| Date of first enrolment | 02/01/2014 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
08028
Spain
Sponsor information
Government
C/Miguel Torres 6
Vilafranca del Penedés
Barcelona
08720
Spain
| sponsor123@gmail.com |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2017 | 22/01/2019 | Yes | No |
Editorial Notes
22/01/2019: Publication reference added
