Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
48 participants
INTERVENTIONAL
2024-10-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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ONS with fibre with added nutrients
Oral nutritional supplement
During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.
ONS without fiber with added nutrients
Oral nutritional supplement
During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.
ONS with fibre without added nutrients
Oral nutritional supplement
During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.
ONS without fibre without added nutrients
Oral nutritional supplement
During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.
Interventions
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Oral nutritional supplement
During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.
Eligibility Criteria
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Inclusion Criteria
2. Able to consume high energy and/or high protein ONS at discretion of the Investigator
3. Written informed consent
4. Willing and able to refrain from smoking during the visits
5. Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.
Exclusion Criteria
2. Any known metabolic condition that interferes with the breakdown of amino acids (e.g. arginase deficiency, urea cycle disorder)
3. Known history of gastric surgery e.g. (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding, gastric balloon.
4. Any known chronic/continuous use, and/or within 24-48h before the visit, of medication that strongly affects with gastric emptying or gastric acid secretion (e.g., metoclopramide, opioid analgesics, calcium channel blockers, Beta-Adrenergic Receptor Agonists, H2 receptor antagonists, proton pump inhibitors; tricyclic antidepressants such as amitriptyline, imipramine, systemic steroids)
5. Known active cancer treatment 4 weeks prior the study start
6. Body Mass Index \>= 30.0 kg/m²
7. Presence of Diabetes Mellitus (self-reported or the use of Diabetes medication: i.e., insulin, biguanides, DPP-4 inhibitors, GLP-1 receptor agonists)
8. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease
9. Known renal dysfunction with protein restriction diet
10. Known allergy to cow's milk protein
11. Known allergy to soy
12. Known galactosaemia
13. Known lactose intolerance
14. Excessive alcohol consumption (use of \> 14 units per week for women or \> 21 units per week for men, on average during the past 6 months).
15. Drug abuse based on investigator's judgement.
16. Any contraindication to oral feeding per se being: any degree of dysphagia, gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
17. Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline
18. Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \& Innovation Center.
65 Years
ALL
Yes
Sponsors
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Nutricia Research
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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24REX0063741
Identifier Type: -
Identifier Source: org_study_id
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