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

Effects of Adding Appetite Stimulants to a Fibre Containing High-Protein ONS on Appetite-Related Outcomes in Older Adults

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Oral nutritional supplement

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danone Nutricia Research; Phone Number: +31 30 2095 000; Email: register.clinicalresearchnutricia@danone.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ONS with fibre with added nutrients	Dietary supplement: 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.
Other: ONS without fiber with added nutrients	Dietary supplement: 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.
Other: ONS with fibre without added nutrients	Dietary supplement: 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.
Other: ONS without fibre without added nutrients	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite satiety score (CSS)	The main outcome parameter in this study is the composite satiety score (CSS), measured from baseline (-5 minutes) until 120 minutes after starting the consumption of the study product.	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety after 120 min	Satiety, fullness, hunger, prospective food consumption measured from baseline until 120 minutes after starting the consumption of the study product measured with composite satiety score questionnaire	more than 120 minutes
Volume consumed	Adherence to use of the study product, defined as volume consumed within 10 minutes relative to 1 serving [%]	120 minutes

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 24REX0063741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No