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Completed

NCT Number: NCT04397146

Palatability and Perceived Satiety of Oral Nutrition Supplements

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.

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Key information

Conditions

Sensory Evaluation Perceived Satiety

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Liking

    Time frame: 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

    Time frame: 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 outcomes

  1. Satiety

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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'

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • Fonterra (Europe) Cooperatie U.A.

Registry information

Official study title

Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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