Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement

NCT05088408 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colonoscopy; Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Mucosa visualization quality (Boston Bowel Preparation Scale)

  Mucosa visualization quality assessed using the Boston Bowel Preparation Scale (0 to 9, 0 being the worst)

  During the procedure

Secondary Outcomes (3)

• Adenoma detection rate

  During the procedure

• Amount of rinsing needed

  During the procedure

• Hunger during bowel preparation

  Reported in the day of the procedure

Study Arms (2)

Control

ACTIVE COMPARATOR

Bowel preparation as usual. Colonoscopy.

Other: Bowel preparation as usual.

Dietary supplement

EXPERIMENTAL

Bowel preparation as usual plus two bottles of the dietary supplement Resource® Energy Apricot. Colonoscopy.

Dietary Supplement: Resource® Energy Apricot

Interventions

Resource® Energy Apricot DIETARY_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.

Dietary supplement

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individual requesting a non-contraindicated colonoscopy (with clinical indication) at the outpatient clinic.

You may not qualify if:

• pregnancy
• Allergy to any ingredient of Resource® Energy Apricot

Sponsors & Collaborators

• Clínica de Gastroenterologia: lead
• Nestlé Portugal SA: collaborator
• Angelini Pharma Portugal, Unipessoal, Lda: collaborator

Study Sites (1)

Clínica de Gastroenterologia

Coimbra, Coimbra District, 3000-098, Portugal

Location

Study Officials

• José AS Medeiros, PhD

  Clínica de Gastroenterologia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: October 21, 2021
• Study Start: October 30, 2020
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

PT (1)