Perceived Satiety Clinical Trial
Official title:
Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults
| Verified date | May 2020 |
| Source | Wageningen University and Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 104 |
| Est. completion date | October 31, 2019 |
| Est. primary completion date | October 31, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - Age 65 years or over - Apparently healthy - Living independently Exclusion Criteria: - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Stichting Wageningen Research | Wageningen | Gelderland |
| Lead Sponsor | Collaborator |
|---|---|
| Wageningen University and Research | Fonterra (Europe) Cooperatie U.A. |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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' | Immediately after consumption of one sip of the ONS product | |
| Primary | 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' | Immediately after finishing consumption of a full portion of the ONS product | |
| Secondary | 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' | Before consumption of the ONS product | |
| Secondary | 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' | Immediately after finishing consumption of a full portion of the ONS product | |
| Secondary | 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' | 1 hour after finishing consumption of a full portion of the ONS product | |
| Secondary | 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' | 2 hours after finishing consumption of a full portion of the ONS product |