MalnutritionAPPOLO IINCT06645184
Adding Appetite Stimulants to an ONS in Older Adults
A study testing Oral nutritional supplement in people with Malnutrition, run by Nutricia Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
- Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.
Who cannot join
- 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
Show all 18Show fewer
- 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.
- 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.
- Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline
- Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \& Innovation Center.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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)
- Conditions
- Malnutrition
- Being tested
- Oral nutritional supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| ONS with fibre with added nutrients | Other | Not described Receives: Dietary Supplement: Oral nutritional supplement |
| ONS without fiber with added nutrients | Other | Not described Receives: Dietary Supplement: Oral nutritional supplement |
| ONS with fibre without added nutrients | Other | Not described Receives: Dietary Supplement: Oral nutritional supplement |
| ONS without fibre without added nutrients | Other | Not described Receives: Dietary Supplement: Oral nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Secondary outcomes (2)
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
Measured: more than 120 minutes
Volume consumed
Adherence to use of the study product, defined as volume consumed within 10 minutes relative to 1 serving [%]
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645184
- Sponsor's protocol ID
- 24REX0063741
- Acronym
- APPOLO II
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Appetite Stimulants to a Fibre Containing High-Protein ONS on Appetite-Related Outcomes in Older Adults
- ClinicalTrials.gov ID
- NCT06645184
- Acronym / sponsor ID
- APPOLO II / 24REX0063741
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
- Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutritional supplementDuring 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. | Dietary supplement | ONS with fibre with added nutrients, ONS with fibre without added nutrients, ONS without fiber with added nutrients, ONS without fibre without added nutrients |
Primary outcome
composite satiety score (CSS)
Time frame: 120 minutes
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.
2 secondary outcomes
Satiety after 120 min
Time frame: more than 120 minutes
Volume consumed
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplement in people with Malnutrition, run by Nutricia Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danone Nutricia research (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite satiety score (CSS) (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.