Palatability and Perceived Satiety of Oral Nutrition Supplements

• Sponsor: Wageningen University and Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT04397146
• Collaborator: Fonterra (Europe) Cooperatie U.A. (Other)
• Enrollment: 104
• Location: 1
• Arm: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 109.2

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Sensory Evaluation; Perceived Satiety	Dietary Supplement: Oral Nutrition Supplement (ONS)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Each study participant evaluates 8 different ONS products on palatability and perceived satietyEach study participant evaluates 8 different ONS products on palatability and perceived satiety
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults
• Actual Study Start Date: Oct 2, 2019
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-blind sensory and satiety evaluation 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.	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

1. Liking [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'

2. Liking [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'

Secondary Outcome Measures

1. Satiety [Before consumption of the ONS product]

   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. Satiety [Immediately after finishing consumption of a full portion of the ONS product]

   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'

3. Satiety [1 hour after finishing consumption of a full portion of the ONS product]

   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'

4. Satiety [2 hours after finishing consumption of a full portion of the ONS product]

   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'

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stichting Wageningen Research	Wageningen	Gelderland	Netherlands	6708 WG

Sponsors and Collaborators

• Wageningen University and Research
• Fonterra (Europe) Cooperatie U.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diederik Esser, project leader clinical trials, Wageningen University and Research
• ClinicalTrials.gov Identifier: NCT04397146
• Other Study ID Numbers: NL70308.081.19
• First Posted: May 21, 2020
• Last Update Posted: May 21, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 21, 2020