Clinical Trials Directory

Trials / Terminated

TerminatedNCT03772444

Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years – 95 Years
Healthy volunteers
Not accepted

Summary

The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

Detailed description

Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTBeetroot juicePatients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
DIETARY_SUPPLEMENTNitrate-depleted beetroot juicePatients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
DIETARY_SUPPLEMENTWaterPatients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.

Timeline

Start date
2018-01-15
Primary completion
2019-05-25
Completion
2019-05-25
First posted
2018-12-11
Last updated
2023-01-20

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03772444. Inclusion in this directory is not an endorsement.