Palatability and Perceived Satiety of Oral Nutrition Supplements

NCT04397146 | Completed

• 1 other identifier: NL70308.081.19
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Evaluation; Perceived Satiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Satiety

  Before consumption of the ONS product

• Satiety

  Immediately after finishing consumption of a full portion of the ONS product

• Satiety

  1 hour after finishing consumption of a full portion of the ONS product

• Satiety

  2 hours after finishing consumption of a full portion of the ONS product

Study Arms (1)

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.

Dietary Supplement: Oral Nutrition Supplement (ONS)

Interventions

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.

Single-blind sensory and satiety evaluation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or over
• Apparently healthy
• Living independently

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: project leader clinical trials

Model Details: Each study participant evaluates 8 different ONS products on palatability and perceived satiety

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: May 21, 2020
• Study Start: October 2, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)