An interventional study of Flavoured Oral Nutritional Supplement (ONS) in Cancer, Nutrition Related Cancer and Malnutrition, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Not applicable, Interventional, and Supportive care
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.
In cancer patients there is great difficulty in maintaining and/or improving their nutritional status if early nutritional support or surveillance measures are not taken, which can prevent progressive deterioration. The act of eating in a traditional way influences the perception of normality or illness in patients. Nutrition not only represents an essential parameter in the development of cancer, but it can also be a fundamental factor in its treatment. In the case of cancer, both the disease and the treatment have a direct impact on nutrition and generate bodily changes that gradually appear as a consequence of them. Cancer produces a direct decrease in intake, due to the disease, the metabolic alteration induced by the tumor, the physiological changes produced, the effects of cancer treatment and the presence of symptoms (depression, anorexia, vomiting, diarrhoea, pain , etc.); mechanically interfering with the normal transit of the digestive tube, or indirectly through the secretion of substances that act on peripheral receptors or on the hypothalamus. The patient may therefore be faced with a tumor cachexia syndrome characterized by weight loss, reduced fat and muscle mass, anorexia with reduced intake, early satiety, hypoalbuminemia, anemia, and progressive weakness, among others. others. This malnutrition aggravates the problem of immunosuppression that the patient already has due to his cancer, and has a great impact on functional capacity, with an increase in complications, the rate of infections, decreases tolerance to cancer treatment, the patient's quality of life and thus their chances of survival.
Oral nutritional support consists of the administration of nutrients and other necessary adjuvant therapeutic substances, with the purpose of improving or maintaining the nutritional status of a patient. This support is indicated for patients who are in different clinical situations such as limitation of intake, swallowing, transit, digestion, absorption and/or metabolism of nutrients, or who have special energy and/or nutrient requirements that cannot be covered with natural food.
Therefore, the main objectives of nutritional supplementation in cancer patients are the following:
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.
For this reason, a randomized, cross-sectional and double-blind pilot study was performed to evaluate different organoleptic properties of 5 oral nutritional prototype of supplements. The investigators included 30 patients. Each volunteer tasted the 5 different prototypes the same day in a different order.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Five different flavours of Oral Nutritional Supplement (ONS) prototypes were tested: tropical, pineapple, brownie, ham, tomato
Dietary Supplement: Flavoured Oral Nutritional Supplement (ONS)
Sensory analysis of different ONS of sweet (pineapple, tropical, brownie) and acid flavoured (tomato, ham)
Also known as: Experimental
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Weight (kg)
It is measured using a digital scale for clinical use (capacity 0-150 kg), with the person positioned with their back to the viewer, without shoes, wearing a minimum of warm clothing (pants and t-shirt), heels together, looking forward and posture straight body.
Time frame: Day 1
Waist circumference (cm)
The subject assumes a position with arms crossed at the chest. The perimeter is taken at the narrowest level, between the lower costal margin (10th rib) and the iliac crest. The anthropometrist stands in front of the subject, who has his arms slightly abducted, to allow the waist to run around the abdomen. Values greater than 80 centimeters (women) and 94 centimeters (men) are considered a risk for cardiovascular diseases.
Time frame: Day 1
Body Mass Index (kg/m2)
It is the relationship between the individual's body weight (kg) and height (m) squared: Weight/Height2. Values greater than 24,9 kg/m2 are considered as overweight
Time frame: Day 1
24 hour food record questionnaire
Questionnaire to find out the nutritional and dietary habits of each participant. The volunteer will write down all the food and drinks ingested in the previous day of clinical visit (24 hours). The answers will allow calculating the total amount of food consumed and calories ingested. In addition, the data will be evaluated quantitatively and qualitatively, classifying the diet in terms of diversity and balance following the recommendations of the Spanish Society of Community Nutrition (SENC 2016).
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Dec 2019, 5 months.
Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's 5 months is below that.
Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto de Investigación Hospital Universitario La Paz →