Compliance of dairy products versus oral nutrition supplements in patients with a risk for malnutrition.

Completed

• Conditions: ondervoeding; malnutrition; undernutrition; 10003018

• Registration Number: NL-OMON41996
• Lead Sponsor: FrieslandCampina Nederland BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-02-15
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

* Risk for malnutrition (MUST = 0 or 1 point and PG-SGA SF score >= 4 and <9)
* Aged 18 years and older
* Able to eat orally and without the help of others
* Able to understand, speak, and write in the Dutch language

Exclusion Criteria

* Use of oral nutrition supplements in the past six months at time of inclusion.
* Receiving treatment of a dietician at time of inclusion.
* High current daily protein intake (less than 12 gram difference between current intake and protein requirement).
* Protein requirements >18 gram protein per day.
* Prescription of oral nutrition supplements by the dietician.
* Contra-indication for dairy products (e.g. lactose-intolerance, cow milk allergy).
* Protein restriction (<=0.8 gram protein / kg actual body weight)
* Diseases associated with a reduced protein intake advice: Congenital disorders of amino acid metabolism; Chronic kidney disease; Kidney transplantation (> 2 months ago); Duchenne muscular dystrophy; Gout.
* Fluid restriction (<=1500 ml).
* Pacemaker.
* Bound to wheel chair, longterm (>6 months).
* Eating disorder.
* Dementia.
* Distance from home to the UMCG is greater than 70 km. (due to practical reasons concerning distribution of the products).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is compliance, specified as adherence to prescription<br /><br>of daily protein goals (daily protein intake). A compliance questionnaire will<br /><br>be assessed to list the experiences of the participant about associated factors<br /><br>of compliance. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are (1) patient experiences (2) urine nitrogen<br /><br>secretion, (13) nutritional status, (24) body composition (BMI, bio-electrical<br /><br>impedance analysis), and (35) hand grip strength. </p><br>