A study to investigate appetite in older adults residing in nursing homes.

An exploratory study investigating the effect of adding an appetite stimulant to an ONS on appetite-related outcomes in older adults residing in nursing homes.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22468

Enrollment

Registered

2021-07-15

Start date

2021-09-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Duration of intervention: 2 weeks Intervention group: One bottle of ONS (125 mL), mixed with an appetite stimulant dissolved in 5 mL of water Control group: One bottle of ONS (125 mL) mixed with 5 mL

Eligibility

Inclusion criteria

Inclusion criteria: 1. 65 years of age or older 2. Residing in a nursing home 3. Able to consume high energy and/or high protein ONS at discretion of the Investigator 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Any known gastrointestinal (GI) disease that interferes with the gastrointestinal motility and nutritional intake, e.g. constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis 2. Any known metabolic condition that interferes with the breakdown of amino acids 3. History of GI surgery (except appendectomy) that interferes with the GI function, e.g. ileostomy, colostomy, (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding 4. Investigator’s uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer’s disease 5. Known allergy to cow’s milk protein 6. Known galactosaemia 7. Known severe lactose intolerance without using lactase 8. Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline

Design outcomes

Primary

Measure	Time frame
The main outcome parameter in this study is the composite satiety score (CSS), measured from baseline until 120 minutes after starting the consumption of the study product: -Area under the curve (AUC; score x minutes) -Incremental area under the curve (iAUC; score x minutes) -Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product -Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product The CSS will be calculated through the equation (satiety + fullness + (100 – hunger) + (100 – prospective food consumption))/ 4. Satiety, fullness, hunger and prospective food consumption will be assessed on a VAS, with scores ranging from 0 to 100. The CSS also ranges from 0 to 100.	—

Measure

Time frame

The main outcome parameter in this study is the composite satiety score (CSS), measured from baseline until 120 minutes after starting the consumption of the study product: -Area under the curve (AUC; score x minutes) -Incremental area under the curve (iAUC; score x minutes) -Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product -Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product The CSS will be calculated through the equation (satiety + fullness + (100 – hunger) + (100 – prospective food consumption))/ 4. Satiety, fullness, hunger and prospective food consumption will be assessed on a VAS, with scores ranging from 0 to 100. The CSS also ranges from 0 to 100.

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Secondary

Measure	Time frame
Other outcome parameters in this study are: -Satiety, fullness, hunger, prospective food consumption measured from baseline until 120 minutes after starting the consumption of the study product - AUC (score x minutes) - iAUC (score x minutes) - Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product - Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product -Adherence to use of the study product, defined as volume consumed within 15 minutes relative to 1 serving (%) -Overall liking of the study product (score), assessed 15 minutes after starting the consumption of the study product on a liking scale ranging from 1 to 10.	—

Measure

Time frame

Other outcome parameters in this study are: -Satiety, fullness, hunger, prospective food consumption measured from baseline until 120 minutes after starting the consumption of the study product - AUC (score x minutes) - iAUC (score x minutes) - Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product - Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product -Adherence to use of the study product, defined as volume consumed within 15 minutes relative to 1 serving (%) -Overall liking of the study product (score), assessed 15 minutes after starting the consumption of the study product on a liking scale ranging from 1 to 10.

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Contacts

Public ContactDanone Nutricia Research

Danone Nutricia Research

Outcome results