Adding Appetite Stimulants to an ONS in Older Adults

NCT06645184 | Not Yet Recruiting

• 1 other identifier: 24REX0063741
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Satiety after 120 min

  more than 120 minutes

• Volume consumed

  120 minutes

Study Arms (4)

ONS with fibre with added nutrients

OTHER

Dietary Supplement: Oral nutritional supplement

ONS without fiber with added nutrients

OTHER

Dietary Supplement: Oral nutritional supplement

ONS with fibre without added nutrients

OTHER

Dietary Supplement: Oral nutritional supplement

ONS without fibre without added nutrients

OTHER

Dietary Supplement: Oral nutritional supplement

Interventions

Oral nutritional supplement DIETARY_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 with added nutrients; ONS with fibre without added nutrients; ONS without fiber with added nutrients; ONS without fibre without added nutrients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• Able to consume high energy and/or high protein ONS at discretion of the Investigator
• Written informed consent
• Willing and able to refrain from smoking during the visits
• Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.

You may not qualify if:

• Any known condition that interferes with the gastric emptying (e.g., gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple sclerosis, Parkinson disease).
• Any known metabolic condition that interferes with the breakdown of amino acids (e.g. arginase deficiency, urea cycle disorder)
• Known history of gastric surgery e.g. (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding, gastric balloon.
• 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)
• Known active cancer treatment 4 weeks prior the study start
• Body Mass Index \>= 30.0 kg/m²
• Presence of Diabetes Mellitus (self-reported or the use of Diabetes medication: i.e., insulin, biguanides, DPP-4 inhibitors, GLP-1 receptor agonists)
• 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
• Known renal dysfunction with protein restriction diet
• Known allergy to cow's milk protein
• Known allergy to soy
• Known galactosaemia
• Known lactose intolerance
• 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).
• Drug abuse based on investigator's judgement.

Sponsors & Collaborators

• Nutricia Research: lead

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Danone Nutricia research

CONTACT

+31 30 2095 000; register.clinicalresearchnutricia@danone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participating subjects are blinded and will not know which of the 4 study products they will consume
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 16, 2024
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share