Palatability and Perceived Satiety of Oral Nutrition Supplements

NCT ID: NCT04397146

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2019-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Nutrition Supplement (ONS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fonterra (Europe) Cooperatie U.A.

UNKNOWN

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

project leader clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL70308.081.19

Identifier Type: -

Identifier Source: org_study_id