ColonoscopyNCT05088408
Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement
A study testing Resource® Energy Apricot and Bowel preparation as usual. in people with Colonoscopy and Bowel Preparation, run by Clínica de Gastroenterologia at 1 site in Portugal.
Trial summary
The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions, yet it has been used off-label to alleviate the effects of hunger during bowel preparation for colonoscopy. Its impact in mucosa visualization quality and hunger alleviation is unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- Resource® Energy Apricot and Bowel preparation as usual.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Oct 2020to 28 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individual requesting a non-contraindicated colonoscopy (with clinical indication) at the outpatient clinic.
Who cannot join
- pregnancy
- Allergy to any ingredient of Resource® Energy Apricot
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Clínica de Gastroenterologia
Coimbra, Coimbra District, 3000-098
About this study
The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions, yet it has been used off-label to alleviate the effects of hunger during bowel preparation for colonoscopy. Its impact in mucosa visualization quality and hunger alleviation is unknown. The product is liquid and nutritious but it is not transparent, thus it is conceivable that it could alleviate the discomfort of hunger during the preparation but possibly compromising mucosa visualization. In this study, participants who will undergo a colonoscopy (requested for an explicit medical indication) will take two bottles of the nutritional supplement during the usual bowel preparation. The quality of mucosal visualization and the participants opinion regarding satiety and product tolerance during bowel preparation will then be analysed.
Read the detailed description
The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions. However, it has been recommended by pharmacists to reduce hunger during bowel preparation for colonoscopy, without any medical prescription or recommendation as there is no scientific evidence regarding this use. Its impact in the quality of mucosal visualization during colonoscopy and in relieving hunger is unknown, thus requiring research.
The dietary supplement is liquid and nutritious, each serving consisting of 200 mL containing carbohydrates 42 g, lipids 10 g, proteins 11.2 g and fiber < 1 g, totalling 303 kcal. It is thus conceivable that it can mitigate the discomfortable feeling of hunger during bowel preparation, but because it is not transparent it could possibly hamper mucosa visualization.
One hundred and fifty control patients (with clinical indication for undergoing colonoscopy) will undergo bowel preparation as usual with the standard of care polyethylene glycol 3350 in 4 litres of water (Klean-Prep®): one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning.
One hundred and fifty patients (with clinical indication for undergoing colonoscopy) will undergo bowel preparation as usual and take two servings of Resource® Energy Apricot.
All patients will be asked about feelings of hunger or side effects of bowel preparation and colonoscopy (nausea, vomits, abdominal pain, abdominal discomfort, abdominal pressure, abdominal bloating, syncope, blood in stool, sleep disturbance, work absenteeism) in a scale from 0 to 10, before and after the colonoscopy. This scale is often used to assess appetite.
Colonoscopic mucosa visualization quality will be assessed in all patients using the Boston Bowel Preparation Scale, which is the most thoroughly validated and recommended scale.
Statistical comparison will the be performed between both groups, regarding colonoscopic mucosa visualization and side effects and sensations experienced, such as hunger.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- Resource® Energy Apricot, Bowel preparation as usual.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource® Energy ApricotDietary supplement
Bowel preparation as usual plus two bottles of Resource® Energy Apricot (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), with ingestion of one bottle of 200 mL of the dietary supplement at 08:00 and the other at 12:00, and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning).
Colonoscopy.
Bowel preparation as usual.Other
Bowel preparation as usual (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning).
Colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Bowel preparation as usual. Colonoscopy. Receives: Other: Bowel preparation as usual. |
| Dietary supplement | Experimental | Bowel preparation as usual plus two bottles of the dietary supplement Resource® Energy Apricot.
Colonoscopy. Receives: Dietary Supplement: Resource® Energy Apricot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosa visualization quality (Boston Bowel Preparation Scale)
Mucosa visualization quality assessed using the Boston Bowel Preparation Scale (0 to 9, 0 being the worst)
Measured: During the procedure
Secondary outcomes (3)
Adenoma detection rate
Adenoma detection rate
Measured: During the procedure
Amount of rinsing needed
Amount of water (mL) injected to wash certain areas of the colon
Measured: During the procedure
Hunger during bowel preparation
Self-reported in a scale from 0 to 10 (10 being the worst)
Measured: Reported in the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start30 Oct 2020
- Primary completion28 May 2022
- Study completion28 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Gastroenterologia
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Portugal SA, Angelini Pharma Portugal, Unipessoal, Lda
- Responsible party
- Sponsor
- Investigators
- José AS Medeiros, PhD, Study chair, Clínica de Gastroenterologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088408
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2021
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement
- ClinicalTrials.gov ID
- NCT05088408
- Acronym / sponsor ID
- 01
- Conditions
- Colonoscopy, Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Clínica de GastroenterologiaUniversity, hospital or other
- Collaborators
- Nestlé Portugal SA, Angelini Pharma Portugal, Unipessoal, Lda
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 21 Oct 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 high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions, yet it has been used off-label to alleviate the effects of hunger during bowel preparation for colonoscopy. Its impact in mucosa visualization quality and hunger alleviation is unknown. The product is liquid and nutritious but it is not transparent, thus it is conceivable that it could alleviate the discomfort of hunger during the preparation but possibly compromising mucosa visualization. In this study, participants who will undergo a colonoscopy (requested for an explicit medical indication) will take two bottles of the nutritional supplement during the usual bowel preparation. The quality of mucosal visualization and the participants opinion regarding satiety and product tolerance during bowel preparation will then be analysed.
Detailed description
The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions. However, it has been recommended by pharmacists to reduce hunger during bowel preparation for colonoscopy, without any medical prescription or recommendation as there is no scientific evidence regarding this use. Its impact in the quality of mucosal visualization during colonoscopy and in relieving hunger is unknown, thus requiring research.
The dietary supplement is liquid and nutritious, each serving consisting of 200 mL containing carbohydrates 42 g, lipids 10 g, proteins 11.2 g and fiber < 1 g, totalling 303 kcal. It is thus conceivable that it can mitigate the discomfortable feeling of hunger during bowel preparation, but because it is not transparent it could possibly hamper mucosa visualization.
One hundred and fifty control patients (with clinical indication for undergoing colonoscopy) will undergo bowel preparation as usual with the standard of care polyethylene glycol 3350 in 4 litres of water (Klean-Prep®): one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning.
One hundred and fifty patients (with clinical indication for undergoing colonoscopy) will undergo bowel preparation as usual and take two servings of Resource® Energy Apricot.
All patients will be asked about feelings of hunger or side effects of bowel preparation and colonoscopy (nausea, vomits, abdominal pain, abdominal discomfort, abdominal pressure, abdominal bloating, syncope, blood in stool, sleep disturbance, work absenteeism) in a scale from 0 to 10, before and after the colonoscopy. This scale is often used to assess appetite.
Colonoscopic mucosa visualization quality will be assessed in all patients using the Boston Bowel Preparation Scale, which is the most thoroughly validated and recommended scale.
Statistical comparison will the be performed between both groups, regarding colonoscopic mucosa visualization and side effects and sensations experienced, such as hunger.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Bowel preparation as usual.Bowel preparation as usual. Colonoscopy. |
| Dietary supplement | Experimental | Dietary Supplement: Resource® Energy ApricotBowel preparation as usual plus two bottles of the dietary supplement Resource® Energy Apricot. Colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- individual requesting a non-contraindicated colonoscopy (with clinical indication) at the outpatient clinic.
Key exclusion criteria (2 listed)
- pregnancy
- Allergy to any ingredient of Resource® Energy Apricot
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 |
|---|---|---|
| Resource® Energy ApricotBowel preparation as usual plus two bottles of Resource® Energy Apricot (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), with ingestion of one bottle of 200 mL of the dietary supplement at 08:00 and the other at 12:00, and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning). Colonoscopy. | Dietary supplement | Dietary supplement |
| Bowel preparation as usual.Bowel preparation as usual (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning). Colonoscopy. | Other | Control |
Primary outcome
Mucosa visualization quality (Boston Bowel Preparation Scale)
Time frame: During the procedure
Mucosa visualization quality assessed using the Boston Bowel Preparation Scale (0 to 9, 0 being the worst)
3 secondary outcomes
Adenoma detection rate
Time frame: During the procedure
Amount of rinsing needed
Time frame: During the procedure
Hunger during bowel preparation
Time frame: Reported in the day of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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. This study is not recruiting at the moment.
José AS Medeiros, PhD study chair
Clínica de Gastroenterologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource® Energy Apricot and Bowel preparation as usual. in people with Colonoscopy and Bowel Preparation, run by Clínica de Gastroenterologia at 1 site in Portugal.
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 2 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosa visualization quality (Boston Bowel Preparation Scale) (time frame: During the procedure). 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 12 Sep 2025.