Palatability and Perceived Satiety of Oral Nutrition Supplements

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.

Study Overview

• Status: Completed
• Conditions: Sensory Evaluation; Perceived Satiety
• Intervention / Treatment: Dietary supplement: Oral Nutrition Supplement (ONS)

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NL70308.081.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No