Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study

NCT05133024 | Recruiting Phase 2

• 1 other identifier: BC-06366
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of the BEET IT study is to examine if preoperative intake of beetroot juice can ameliorate gastrointestinal (GI) recovery after colorectal surgery and thereby help to reduce the duration of postoperative ileus (POI) and prevent prolonged POI. Adult patients undergoing laparoscopic colorectal surgery are randomized 1:1 to consume either concentrated beetroot juice (active intervention) or nitrate-depleted concentrated beetroot juice (placebo) during the week before their surgery. Blood, tissue and/or fecal samples are collected at specific time points pre- and/or postoperatively to study markers related to inflammation, oxidative stress and GI function. Patients are followed from the week before surgery (start of the intervention) until 3 months post-surgery. The study takes place at 5 hospitals in Flanders, Belgium.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• Postoperative recovery of gastrointestinal (GI) function

  composite endpoint requiring recovery of both upper GI functions (tolerance of a solid diet) and lower GI functions (passage of flatus and stool)

  hours after the end of surgery (suture)

Secondary Outcomes (9)

• First passage of flatus

  first occurence after the end of surgery (suture)

• First passage of stool

  first occurence after the end of surgery (suture)

• First tolerance of liquids

  first occurence after the end of surgery (suture)

• First tolerance of a semi-solid diet

  first occurence after the end of surgery (suture)

• First tolerance of a solid diet

  first occurence after the end of surgery (suture)

Study Arms (2)

beetroot juice

ACTIVE COMPARATOR

Brand: BEET IT sport NITRATE 400 concentrated beetroot shot (James White Drinks Ltd.) Dosage regimen: 7 shots of 70 mL, once daily in the morning, on 7 consecutive days before surgery

Dietary Supplement: concentrated beetroot juice

nitrate-depleted beetroot juice

PLACEBO COMPARATOR

Brand: BEET IT sport NITRATE 400 nitrate-depleted concentrated beetroot shot (James White Drinks Ltd.) Dosage regimen: 7 shots of 70 mL, once daily in the morning, on 7 consecutive days before surgery

Dietary Supplement: concentrated beetroot juice

Interventions

concentrated beetroot juice DIETARY_SUPPLEMENT

Nitrate supplementation; natural source of dietary nitrate

Also known as: BEET IT sport NITRATE 400 concentrated beetroot shot

beetroot juice; nitrate-depleted beetroot juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion

You may not qualify if:

• General:
• \< 18 years of age
• Pregnancy or breast feeding
• Medical:
• Psychiatric pathology capable of affecting comprehension and judgment faculty
• History of inflammatory bowel disease
• Chronic vascular disease affecting the intestines
• Chronic constipation (\<= 2 bowel movements/week)
• Previous abdominal or pelvic radiation treatment
• Use of gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
• Use of nitrates (e.g. isosorbide dinitrate, nitroglycerin), including daily consumption of beetroot juice (unless stopped for a month prior to the intervention period)
• Hypotension (\< 100/60 mmHg)
• Uncontrolled diabetes mellitus
• Renal or hepatic insufficiency
• Known allergies or intolerances to beetroot, nitrates/nitrites

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (6)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

Hospital East-Limburg

Genk, 3600, Belgium

ACTIVE NOT RECRUITING

AZ Sint-Lucas Ghent

Ghent, 9000, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

VITAZ

Sint-Niklaas, 9100, Belgium

RECRUITING

Central Study Contacts

Wim Ceelen, MD, PhD

CONTACT

093326251; wim.ceelen@ugent.be

Karen De Meuleneir, MSc

CONTACT

karen.demeuleneir@uzgent.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Beetroot juice bottles are delivered at the central investigational site in labeled boxes indicating whether they are active or control juice. The bottles themselves are identical in appearance and only distinguishable by the manufacturer through the production code. Blinding of the juices is done by an independent party who is responsible for removing the labels, indicating whether the juices are active or nitrate-depleted juice, from the boxes, and assigning an intervention letter code to active or control beetroot juice as 'A' or 'B', without revealing which is which. Sets of 7 bottles, corresponding with the dosage regimen, from A or B according to the randomization list made by an independent statistician, are then labelled with an unique randomization letter code comprising of 2 randomly generated letters, followed by an underscore and a numerical index from 1 to 7 (e.g. AX\ 1,…, AX\ 7) to assure allocation concealment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric double-blind randomized controlled prospective phase II study

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 24, 2021
• Study Start: March 31, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

BE (6)