Study to Evaluate the Organoleptic Perception of Oral Nutritional Supplements for Oncological Patients

NCT05488184 | Completed

• 1 other identifier: HULP 5254
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Nutritional therapy is key to helping cancer patients get the nutrients they need to maintain body weight, strength, tissue and organ integrity, and face likely infections. Some cancer treatments work best when the patient is well nourished and has enough calories and macronutrients from food. According to the latest consensus, the first step in nutritional intervention is nutritional recommendations or dietary advice. These recommendations must be realized if the patient is capable of ingesting at least 75% of the nutritional requirements that correspond to them and, if there is no approach to an upcoming risk therapy. As long as the oral route is not damaged, in dietary advice this should always be the first option. Increasingly, laboratories specialized in nutritional products prepare and improve the composition of supplements. They are complete, specific and perfect to meet the dietary needs of patients who require it. But, to fulfill their function, they have to be ingested by people and for that they have to have good organoleptic characteristics, a very important nuance that is sometimes not taken into account in the manufacture of these products. It is the object of Adventia Pharma, S.L. develop new Oral Nutritional Supplements specific for cancer patients and that meet optimal organoleptic characteristics. For this reason, a pilot study will be carried out that will evaluate different sensory and organoleptic aspects of the prototypes of supplements developed by the company to determine the consumer's reaction to the products developed and subsequently be able to select the one with the greatest acceptance.

Conditions

Cancer; Nutrition Related Cancer; Malnutrition

Keywords

cancer; nutrition; oral nutrition supplement; organoleptic properties; pilot study

Outcome Measures

Primary Outcomes (6)

• Color of the experimental ONS

  It will be evaluated through an Organoleptic Hedonic Scale that will measure 5 levels, to which a score will be associated: I dislike it a lot (1 point); I dislike it moderately (2 points); I neither like nor dislike (3 points); I like it moderately (4 points); I like it a lot (5 points). The minimum score of the questionnaire is 6 points, while the maximum is 30.

  Day 1

• Taste of the experimental ONS

  It will be evaluated through an Organoleptic Hedonic Scale that will measure 5 levels, to which a score will be associated: I dislike it a lot (1 point); I dislike it moderately (2 points); I neither like nor dislike (3 points); I like it moderately (4 points); I like it a lot (5 points). The minimum score of the questionnaire is 6 points, while the maximum is 30.

  Day 1

• Flavor of the experimental ONS

  It will be evaluated through an Organoleptic Hedonic Scale that will measure 5 levels, to which a score will be associated: I dislike it a lot (1 point); I dislike it moderately (2 points); I neither like nor dislike (3 points); I like it moderately (4 points); I like it a lot (5 points). The minimum score of the questionnaire is 6 points, while the maximum is 30.

  Day 1

• Aftertaste of the experimental ONS

  It will be evaluated through an Organoleptic Hedonic Scale that will measure 5 levels, to which a score will be associated: I dislike it a lot (1 point); I dislike it moderately (2 points); I neither like nor dislike (3 points); I like it moderately (4 points); I like it a lot (5 points). The minimum score of the questionnaire is 6 points, while the maximum is 30.

  Day 1

• Texture of the experimental ONS

  It will be evaluated through an Organoleptic Hedonic Scale that will measure 5 levels, to which a score will be associated: I dislike it a lot (1 point); I dislike it moderately (2 points); I neither like nor dislike (3 points); I like it moderately (4 points); I like it a lot (5 points). The minimum score of the questionnaire is 6 points, while the maximum is 30.

  Day 1

• Thickness of the experimental ONS

  It will be evaluated through an Organoleptic Hedonic Scale that will measure 5 levels, to which a score will be associated: I dislike it a lot (1 point); I dislike it moderately (2 points); I neither like nor dislike (3 points); I like it moderately (4 points); I like it a lot (5 points). The minimum score of the questionnaire is 6 points, while the maximum is 30.

  Day 1

Secondary Outcomes (4)

• Weight (kg)

  Day 1

• Waist circumference (cm)

  Day 1

• Body Mass Index (kg/m2)

  Day 1

• 24 hour food record questionnaire

  Day 1

Study Arms (1)

Dietary Supplement

EXPERIMENTAL

Five different flavours of Oral Nutritional Supplement (ONS) prototypes were tested: tropical, pineapple, brownie, ham, tomato

Dietary Supplement: Flavoured Oral Nutritional Supplement (ONS)

Interventions

Flavoured Oral Nutritional Supplement (ONS) DIETARY_SUPPLEMENT

Sensory analysis of different ONS of sweet (pineapple, tropical, brownie) and acid flavoured (tomato, ham)

Also known as: Experimental

Dietary Supplement

Eligibility Criteria

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

You may qualify if:

• Men and women from 18 years old.
• Patients diagnosed with cancer (any type) and who have started or are going to start with chemo and/or radiotherapy treatment with or without surgery.
• Adequate cultural level and understanding
• Agree to participate in the study

You may not qualify if:

• Subjects with severe infection or major surgery in the previous three months.
• Subjects with an infectious process at the time of the study.
• Subjects with insulin dependent diabetes.
• Subjects with dementia, mental illness or decreased cognitive function.
• Pregnant or breastfeeding women.
• Subjects with body mass index ≥ 40kg/m2.
• Subjects who rejects oral nutritional supplements.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Adventia Pharma: collaborator

Study Sites (1)

Bricia Lopez Plaza

Madrid, 28012, Spain

Location

MeSH Terms

Conditions

Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Marina Morato Martínez, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: June 26, 2019
• Primary Completion: December 19, 2019
• Study Completion: June 30, 2020
• Last Updated: August 4, 2022

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)