Health TrialsbyHealthPanel

Adding Appetite Stimulants to an ONS in Older Adults

ConditionMalnutrition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNutricia Research

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

65 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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: ONS with fibre with added nutrientsOther 1 intervention
Group B: ONS without fiber with added nutrientsOther 1 intervention
Group C: ONS with fibre without added nutrientsOther 1 intervention
Group D: ONS without fibre without added nutrientsOther 1 intervention

Trial outcomes

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.

Time frame
120 minutes

Secondary outcomes

1

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

Time frame
more than 120 minutes
2

Volume consumed

Adherence to use of the study product, defined as volume consumed within 10 minutes relative to 1 serving \[%\]

Time frame
120 minutes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutricia Research

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: