Postoperative IleusPhase 2BEET ITNCT05133024
Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study
A Phase 2 study testing concentrated beetroot juice in people with Postoperative Ileus, run by University Hospital, Ghent at 6 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- concentrated beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 6 sitesBelgium
- Study dates
- 31 Mar 2021to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion
Who cannot join
- General:
- < 18 years of age
- Pregnancy or breast feeding
- Medical:
- Psychiatric pathology capable of affecting comprehension and judgment faculty
- History of inflammatory bowel disease
Show all 25Show fewer
- Chronic vascular disease affecting the intestines
- Chronic constipation (<= 2 bowel movements/week)
- Previous abdominal or pelvic radiation treatment
- Recent (< 3 months before inclusion) or current intra-abdominal infection or inflammation (e.g. diverticulitis, appendicitis, cholecystitis)
- 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
- Enrollment in other clinical trials/experiments, unless approved by the Ethics Committee(s)
- Surgical:
- History of prior colorectal surgery
- Emergency surgery
- Open surgery
- Colorectal surgery not requiring an anastomosis (e.g. colotomy, wedge resection)
- More than 1 bowel anastomosis planned
- Concomitant surgical procedures required (e.g. resection of liver or lung metastases)
- Protective stoma planned
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karen De Meuleneir, MSc contact
6 sites in 1 country
Belgium6 sites, 5 recruiting
- Recruiting
Antwerp University Hospital
Edegem, 2650
Sylvie Van den Broeck, MD, Sylvie.VandenBroeck@uza.be
Lieselotte Iket, lieselotte.iket@uza.be
- Active, not recruiting
Hospital East-Limburg
Genk, 3600
- Recruiting
AZ Sint-Lucas Ghent
Ghent, 9000
Kjell Fierens, MD, kjell.fierens@azsintlucas.be
Barbara Vincent, barbara.vincent@azsintlucas.be
- Recruiting
Ghent University Hospital
Ghent, 9000
Karen De Meuleneir, MSc, karen.demeuleneir@uzgent.be
Sarah Cosyns, PhD, sarah.cosyns@ugent.be
- Recruiting
University Hospital Leuven
Leuven, 3000
Albert Wolthuis, MD, PhD, albert.wolthuis@uzleuven.be
Isabelle Terrasson, isabelle.terrasson@uzleuven.be
- Recruiting
VITAZ
Sint-Niklaas, 9100
Ignace De Keukelaere, MD, Ignace.DeKeukelaere@vitaz.be
Lise Vermeir, MSc, Lise.Vermeir@vitaz.be
About this study
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.
Read the detailed description
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, remains one of the most common complications following abdominal surgery. It is characterized by the presence of nausea and vomiting, the inability to tolerate oral diet, abdominal distension and delayed passage of flatus and stool. POI usually resolves within 3 to 5 days, but when prolonged, it can lead to increased morbidity, prolonged hospitalization and increased healthcare costs. In patients undergoing colorectal surgery, the reported incidence of prolonged POI (PPOI) is 10.2%. Prevention and treatment remains mainly supportive and no single effective treatment is currently available. Because of its multifactorial origin and possible exogenous factors, prevention and treatment generally requires a multimodal approach. Many of these strategies are part of the Enhanced Recovery after Surgery (ERAS) program. The pathophysiology of POI is marked by an acute neurogenic phase followed by a prolonged inflammatory phase and alterations in the enteric neurotransmission. The pathogenesis involves inflammation and oxidative stress, similar to ischemia/reperfusion (I/R) injury. Both I/R injury and POI are associated with downregulation of nitric oxide (NO) synthases. In this sense, beetroot juice holds considerable promise. Beetroot is a rich source of inorganic nitrate. Consumption of nitrate-rich foods increases the concentration of NO metabolites in the blood and tissues via the enterosalivary nitrate-nitrite-NO pathway, independently of the traditional pathway via the endogenous NOS enzymes, which tends to become less effective in older age and in environments wherein oxygen availability is limited such as during hypoxia and I/R injury. Interest goes to the effects of preoperative beetroot juice supplementation on postoperative GI recovery and POI duration after laparoscopic colorectal surgery. A proof of concept study with 12 patients at our lab already showed promising results. We now want to validate the results in a bigger group of patients via a multicentric double-blind randomized controlled prospective phase II study.
- Conditions
- Postoperative Ileus
- Being tested
- concentrated beetroot juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated beetroot juiceDietary supplement
Also called BEET IT sport NITRATE 400 concentrated beetroot shot
Nitrate supplementation; natural source of dietary nitrate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: concentrated beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: hours after the end of surgery (suture)
Secondary outcomes (9)
First passage of flatus
recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
Measured: first occurence after the end of surgery (suture)
First passage of stool
recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
Measured: first occurence after the end of surgery (suture)
First tolerance of liquids
liquids: no chewing required, can be quickly swallowed as such, can be ingested with a straw (e.g. water, coffee, tea, juice, soda), recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
Measured: first occurence after the end of surgery (suture)
First tolerance of a semi-solid diet
semi-solid food: no or limited biting and chewing required, can be easily swallowed, usually ingested with a spoon or fork (e.g. yoghurt, eggs, soft cheeses), recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
Measured: first occurence after the end of surgery (suture)
First tolerance of a solid diet
solid food: proper and sustained biting and chewing required, cannot be swallowed as such, a knife is usually required to cut the food (e.g. steak, raw vegetables, crisp fruit), recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
Measured: first occurence after the end of surgery (suture)
Incidence and recovery of PPOI
according to the PPOI definition of Vather et al., 2013
Measured: until hospital discharge after surgery
Postoperative length of hospital stay
from the end of surgery (day 0) until discharge (alive) from hospital, recorded in days (standard of care)
Measured: until hospital discharge after surgery
Number and types of postoperative complications
according to Clavien-Dindo, CCI
Measured: until 3 months after surgery
Levels of specific biomarkers in blood, tissues and/or feces
markers for inflammation and oxidative stress, NO bioavailability, intestinal barrier function and permeability
Measured: 4 time points: (1) inclusion, (2) day of surgery, (3) postoperative day 1, (4) postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start31 Mar 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric double-blind randomized controlled prospective phase II study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133024
- Sponsor's protocol ID
- BC-06366
- Acronym
- BEET IT
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study
- ClinicalTrials.gov ID
- NCT05133024
- Acronym / sponsor ID
- BEET IT / BC-06366
- Conditions
- Postoperative Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, remains one of the most common complications following abdominal surgery. It is characterized by the presence of nausea and vomiting, the inability to tolerate oral diet, abdominal distension and delayed passage of flatus and stool. POI usually resolves within 3 to 5 days, but when prolonged, it can lead to increased morbidity, prolonged hospitalization and increased healthcare costs. In patients undergoing colorectal surgery, the reported incidence of prolonged POI (PPOI) is 10.2%. Prevention and treatment remains mainly supportive and no single effective treatment is currently available. Because of its multifactorial origin and possible exogenous factors, prevention and treatment generally requires a multimodal approach. Many of these strategies are part of the Enhanced Recovery after Surgery (ERAS) program. The pathophysiology of POI is marked by an acute neurogenic phase followed by a prolonged inflammatory phase and alterations in the enteric neurotransmission. The pathogenesis involves inflammation and oxidative stress, similar to ischemia/reperfusion (I/R) injury. Both I/R injury and POI are associated with downregulation of nitric oxide (NO) synthases. In this sense, beetroot juice holds considerable promise. Beetroot is a rich source of inorganic nitrate. Consumption of nitrate-rich foods increases the concentration of NO metabolites in the blood and tissues via the enterosalivary nitrate-nitrite-NO pathway, independently of the traditional pathway via the endogenous NOS enzymes, which tends to become less effective in older age and in environments wherein oxygen availability is limited such as during hypoxia and I/R injury. Interest goes to the effects of preoperative beetroot juice supplementation on postoperative GI recovery and POI duration after laparoscopic colorectal surgery. A proof of concept study with 12 patients at our lab already showed promising results. We now want to validate the results in a bigger group of patients via a multicentric double-blind randomized controlled prospective phase II study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric double-blind randomized controlled prospective phase II study
| Arm | Type | Receives |
|---|---|---|
| beetroot juice | Active comparator | Dietary Supplement: concentrated beetroot juiceBrand: 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 |
| nitrate-depleted beetroot juice | Placebo comparator | Dietary Supplement: concentrated beetroot juiceBrand: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion
Key exclusion criteria (25 listed)
- < 18 years of age
- Pregnancy or breast feeding
- Psychiatric pathology capable of affecting comprehension and judgment faculty
- History of inflammatory bowel disease
- Chronic vascular disease affecting the intestines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concentrated beetroot juiceAlso: BEET IT sport NITRATE 400 concentrated beetroot shotNitrate supplementation; natural source of dietary nitrate | Dietary supplement | beetroot juice, nitrate-depleted beetroot juice |
Primary outcome
Postoperative recovery of gastrointestinal (GI) function
Time frame: hours after the end of surgery (suture)
composite endpoint requiring recovery of both upper GI functions (tolerance of a solid diet) and lower GI functions (passage of flatus and stool)
9 secondary outcomes
First passage of flatus
Time frame: first occurence after the end of surgery (suture)
First passage of stool
Time frame: first occurence after the end of surgery (suture)
First tolerance of liquids
Time frame: first occurence after the end of surgery (suture)
First tolerance of a semi-solid diet
Time frame: first occurence after the end of surgery (suture)
First tolerance of a solid diet
Time frame: first occurence after the end of surgery (suture)
Incidence and recovery of PPOI
Time frame: until hospital discharge after surgery
Postoperative length of hospital stay
Time frame: until hospital discharge after surgery
Number and types of postoperative complications
Time frame: until 3 months after surgery
Levels of specific biomarkers in blood, tissues and/or feces
Time frame: 4 time points: (1) inclusion, (2) day of surgery, (3) postoperative day 1, (4) postoperative day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen De Meuleneir, MSc contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing concentrated beetroot juice in people with Postoperative Ileus, run by University Hospital, Ghent at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wim Ceelen, MD, PhD (093326251 ext. +32, wim.ceelen@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recovery of gastrointestinal (GI) function (time frame: hours after the end of surgery (suture)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.