Adding Appetite Stimulants to an ONS in Older Adults (APPOLO II)

Nutricia

Status: Not yet enrolling

Conditions: Malnutrition

Treatments: Dietary Supplement: Oral nutritional supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06645184

24REX0063741

Details and patient eligibility

About

Study to determine whether adding specific nutrients to a high-protein oral nutritional support (ONS), with and without fibre can reduce the feeling of satiety and may increase appetite in adults older than 65 years. This contributes to research into a new type of nutritional nutrition for people with disease related malnutrition (DRM)

Enrollment: 48 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 65 years of age or older
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

1. Any known condition that interferes with the gastric emptying (e.g., gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple sclerosis, Parkinson disease).
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 4 patient groups

ONS with fibre with added nutrients

Other group

Treatment:

Dietary Supplement: Oral nutritional supplement

ONS without fiber with added nutrients

Other group

Treatment:

Dietary Supplement: Oral nutritional supplement

ONS with fibre without added nutrients

Other group

Treatment:

Dietary Supplement: Oral nutritional supplement

ONS without fibre without added nutrients

Other group

Treatment:

Dietary Supplement: Oral nutritional supplement