Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Old… (NCT06478147) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults
Ireland17 participantsStarted 2023-12-02
Plain-language summary
Reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. Strategies to increase appetite are needed to improve healthy ageing. This study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. This study will compare the effects of the ingredient added to an oral nutritional supplement (ONS) versus the ONS alone versus the ingredient dissolved in water on appetite in older adults. By studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.
Who can participate
Age range
60 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Community-dwelling,
* Age 60+ years
* Poor appetite (Simplified Nutritional Appetite Questionnaire (SNAQ) score \</=14, answer a, b or c to Q.1 on SNAQ or answer b, c, or d to CES-D question regarding poor appetite in the past week)
* BMI 20-25kg/m2
Exclusion Criteria:
* Current medical condition or medication known to impact appetite or energy intake
* Other medical condition that would impact study participation and outcomes, as judged by the study investigator.
* Heavy smoker (\>10/day)
* Inability to come to study centre
* Currently participating in another intervention study
* Lacking informed consent
* Allergic to or unwilling to consume any of the study test foods
* Loss of taste or smell associated with COVID-19
* Unable to walk across a room
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pre-meal and changes in Hunger
Timeframe: 9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner
2
Energy Intake (EI) from an ad libitum breakfast meal (kilocalories)
Timeframe: Measures taken immediately following the ad libitum test meal (a single measurement)