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
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)
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 →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.
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Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Oral nutritional supplement
Dietary Supplement: Oral nutritional supplement
Dietary Supplement: Oral nutritional supplement
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.
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
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
Volume consumed
Adherence to use of the study product, defined as volume consumed within 10 minutes relative to 1 serving \[%\]
Time frame: 120 minutes
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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.
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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