Sensory EvaluationNCT04397146
Palatability and Perceived Satiety of Oral Nutrition Supplements
A study testing Oral Nutrition Supplement (ONS) in people with Sensory Evaluation and Perceived Satiety, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
The objective of the study is to evaluate palatability (primary objective) and perceived satiating effects (secondary objective) of two Oral Nutrition Supplements (ONS) prototypes and six commercially available ONS products. The products are matched on calorie content per portion. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensory Evaluation, Perceived Satiety
- What is being tested?
- Oral Nutrition Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2019to 31 Oct 2019
- 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
- Age 65 years or over
- Apparently healthy
- Living independently
Who cannot join
- Allergies to soy, dairy or gluten
- Following a specific diet
- BMI>30 kg/m2
- Reduced kidney function
- Suffering from Alzheimer's disease, Dementia, Parkinson's Disease, Cancer, Kidney Disease or Diabetes
- Suffering from Dysphagia
Show all 10Show fewer
- Already using oral nutritional supplements
- Receiving any medical treatment that is known to reduce the taste or sense of smell
- Current smokers
- Participation in another clinical trial at the same time
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
Official title: Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults
The objective of the study is to evaluate palatability (primary objective) and perceived satiating effects (secondary objective) of two Oral Nutrition Supplements (ONS) prototypes and six commercially available ONS products. The products are matched on calorie content per portion.
The study is a single-blind intervention with a within-subjects design. In total 104 apparently healthy and independently living older adults aged 65 will be recruited to participate. Participants will visit the research facilities eight times in a period of one month. On each test-day participants will consume and evaluate a single product.
- Conditions
- Sensory Evaluation, Perceived Satiety
- Being tested
- Oral Nutrition Supplement (ONS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutrition Supplement (ONS)Dietary supplement
Consumption of a portion of 300-320kcal (based on a standard single serve for ONS products) with a two hour follow-up. Products include: 2 Prototype Oral Nutrition Supplements (ONS) with 2.4kcal/ml and respectively 9.6% protein and 14.4% protein; 6 Commercially available Oral Nutrition Supplements with varying energy and protein levels.
| Study group | Role | What they receive |
|---|---|---|
| Single-blind sensory and satiety evaluation | Experimental | In total 8 different ONS products are consumed and evaluated, each product on a separate test day. The order of products is randomized between study participants. Receives: Dietary Supplement: Oral Nutrition Supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liking
Questionnaire evaluating overall liking, liking of taste, liking of creaminess, liking of sweetness, liking of thickness and liking of aftertaste on a 11-points categorical scale ranging from 1='do not like at all' to 11='like very much'
Measured: Immediately after consumption of one sip of the ONS product
Liking
Questionnaire evaluating overall liking, liking of taste, liking of thickness and liking of aftertaste on a 11-points categorical scale ranging from 1='do not like at all' to 11='like very much'
Measured: Immediately after finishing consumption of a full portion of the ONS product
Secondary outcomes (4)
Satiety
Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much'
Measured: Before consumption of the ONS product
Satiety
Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much'
Measured: Immediately after finishing consumption of a full portion of the ONS product
Satiety
Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much'
Measured: 1 hour after finishing consumption of a full portion of the ONS product
Satiety
Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much'
Measured: 2 hours after finishing consumption of a full portion of the ONS product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start2 Oct 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory EvaluationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each study participant evaluates 8 different ONS products on palatability and perceived satiety
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Fonterra (Europe) Cooperatie U.A.
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397146
- Sponsor's protocol ID
- NL70308.081.19
- Status last verified
- May 2020
- First submitted
- 7 Jan 2020
- Last updated
- 21 May 2020
- 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults
- ClinicalTrials.gov ID
- NCT04397146
- Acronym / sponsor ID
- NL70308.081.19
- Conditions
- Sensory Evaluation, Perceived Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Fonterra (Europe) Cooperatie U.A.
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 21 May 2020 (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.
The objective of the study is to evaluate palatability (primary objective) and perceived satiating effects (secondary objective) of two Oral Nutrition Supplements (ONS) prototypes and six commercially available ONS products. The products are matched on calorie content per portion.
The study is a single-blind intervention with a within-subjects design. In total 104 apparently healthy and independently living older adults aged 65 will be recruited to participate. Participants will visit the research facilities eight times in a period of one month. On each test-day participants will consume and evaluate a single product.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each study participant evaluates 8 different ONS products on palatability and perceived satiety
| Arm | Type | Receives |
|---|---|---|
| Single-blind sensory and satiety evaluation | Experimental | Dietary Supplement: Oral Nutrition Supplement (ONS)In total 8 different ONS products are consumed and evaluated, each product on a separate test day. The order of products is randomized between study participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years or over
- Apparently healthy
- Living independently
Key exclusion criteria (10 listed)
- Allergies to soy, dairy or gluten
- Following a specific diet
- BMI>30 kg/m2
- Reduced kidney function
- Suffering from Alzheimer's disease, Dementia, Parkinson's Disease, Cancer, Kidney Disease or Diabetes
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 Nutrition Supplement (ONS)Consumption of a portion of 300-320kcal (based on a standard single serve for ONS products) with a two hour follow-up. Products include: 2 Prototype Oral Nutrition Supplements (ONS) with 2.4kcal/ml and respectively 9.6% protein and 14.4% protein; 6 Commercially available Oral Nutrition Supplements with varying energy and protein levels. | Dietary supplement | Single-blind sensory and satiety evaluation |
Primary outcome
Liking
Time frame: Immediately after consumption of one sip of the ONS product
Questionnaire evaluating overall liking, liking of taste, liking of creaminess, liking of sweetness, liking of thickness and liking of aftertaste on a 11-points categorical scale ranging from 1='do not like at all' to 11='like very much'
Liking
Time frame: Immediately after finishing consumption of a full portion of the ONS product
Questionnaire evaluating overall liking, liking of taste, liking of thickness and liking of aftertaste on a 11-points categorical scale ranging from 1='do not like at all' to 11='like very much'
4 secondary outcomes
Satiety
Time frame: Before consumption of the ONS product
Satiety
Time frame: Immediately after finishing consumption of a full portion of the ONS product
Satiety
Time frame: 1 hour after finishing consumption of a full portion of the ONS product
Satiety
Time frame: 2 hours after finishing consumption of a full portion of the ONS product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
Related trials for Sensory Evaluation
Not yet recruitingObservational study
Screening Protocol
Pain
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Not yet recruiting
Assessment of Binocular Vision Function With Neos™ (ROCKET)
Binocular Vision Dysfunction
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutrition Supplement (ONS) in people with Sensory Evaluation and Perceived Satiety, run by Wageningen University and Research at 1 site in Netherlands.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liking (time frame: Immediately after consumption of one sip of the ONS product). The study lists 2 primary outcomes in all. 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 21 May 2020.