ClinicalTrials.gg
Not yet recruitingNCT06645184APPOLO IIUpdated Oct 16, 2024

Adding Appetite Stimulants to an ONS in Older Adults

An interventional study of Oral nutritional supplement in Malnutrition, sponsored by Nutricia Research. Not yet recruiting. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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)

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Conditions studied

  • Malnutrition

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03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 48 is below the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Nutricia Research is the lead sponsor of 51 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  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

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 )
  5. Known active cancer treatment 4 weeks prior the study start
  6. >= 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 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
48 participants (estimated)

Study arms

  • Other
    ONS with fibre with added nutrients

    Dietary Supplement: Oral nutritional supplement

  • Other
    ONS without fiber with added nutrients

    Dietary Supplement: Oral nutritional supplement

  • Other
    ONS with fibre without added nutrients

    Dietary Supplement: Oral nutritional supplement

  • Other
    ONS without fibre without added nutrients

    Dietary Supplement: Oral nutritional supplement

Interventions

  • Dietary supplementOral 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.

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Jun 2025, 8 months later.

Of 418 interventional studies with no phase under Malnutrition, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2024
First posted
Oct 16, 2024
StartEst.
Oct 2024
Primary completionEst.
Jun 2025
CompletionEst.
Jun 2025
Last update
Oct 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06645184
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Oct 2024 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Oct 16, 2024

Study contacts

Danone Nutricia research
Contact
register.clinicalresearchnutricia@danone.com
+31 30 2095 000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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