NCT03076463: GRAPOM

Grape Pomace Polyphenols and Cardiometabolic Risk

Completed NA Last updated 5 April 2018

What this trial tests

NA trial testing GRAPOM in Subjects at Cardiometabolic Risk in 49 participants. Completed in 20 December 2017.

Timeline

10 March 2017

Primary endpoint
7 July 2017

20 December 2017

Quick facts

Lead sponsor	National Research Council, Spain
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	49
Start date	10 March 2017
Primary completion	7 July 2017
Estimated completion	20 December 2017
Sites	1 location across Spain

Drugs / interventions tested

• GRAPOM

Conditions studied

• Subjects at Cardiometabolic Risk — all drugs for Subjects at Cardiometabolic Risk →

Sponsor

National Research Council, Spain

Who can join

Adults 18 to 70, any sex, with Subjects at Cardiometabolic Risk. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this is study is to evaluate the long-term effects of grape polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Also, studies on the long-term effect of grape polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so clinical trials on this topic are needed.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modifications of Gut Microbiota after Grape Pomace Supplementation in Subjects at Cardiometabolic Risk: A Randomized Cross-Over Controlled Clinical Trial.
   Ramos-Romero S, Martínez-Maqueda D, Hereu M, Amézqueta S, et al · · 2020 · cited 21× · PMID 32933009 · DOI 10.3390/foods9091279
2. Proanthocyanidins: Impact on Gut Microbiota and Intestinal Action Mechanisms in the Prevention and Treatment of Metabolic Syndrome.
   Redondo-Castillejo R, Garcimartín A, Hernández-Martín M, López-Oliva ME, et al · · 2023 · cited 19× · PMID 36982444 · DOI 10.3390/ijms24065369
3. Relationship between iron status markers and insulin resistance: an exploratory study in subjects with excess body weight.
   Vaquero MP, Martínez-Maqueda D, Gallego-Narbón A, Zapatera B, et al · · 2020 · cited 16× · PMID 32821534 · DOI 10.7717/peerj.9528
4. Potential Relationship between the Changes in Circulating microRNAs and the Improvement in Glycaemic Control Induced by Grape Pomace Supplementation.
   Léniz A, Martínez-Maqueda D, Fernández-Quintela A, Pérez-Jiménez J, et al · · 2021 · cited 3× · PMID 34574169 · DOI 10.3390/foods10092059