Randomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support.

Randomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support. - Compass

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36680

Enrollment

Registered

2011-01-27

Start date

2010-12-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

malnutrition poor nutritional status

Interventions

One group receives daily at least 1 bottle of the new high-energy high-protein oral nutritional supplement, the other group receives daily at least 1 bottle of the standard high-energy high-protein

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male/female subjects >= 65 years of age 2. Subject is in need of oral nutritional support of >= 300 kcal/day 3. Subject is expected to require oral nutritional support for at least 8 weeks 4. Subject has given written informed consent 5. Subject is able to comply with the protocol (e.g. answer questions, collect urine)

Exclusion criteria

Exclusion criteria: 1. Known inflammatory bowel disease (e.g. Crohn*s disease) 2. Known lactose intolerance and not using lactase 3. Known galactosaemia 4. Known cow*s milk allergy 5. Known major hepatic dysfunction: symptomatic hepatic dysfunction or previous serum transaminase (ALAT, ASAT, or alkaline phosphatase) levels more than 5 times upper limit of normal 6. Known renal dysfunction: symptomatic renal dysfunction or a previous GFR

Design outcomes

Secondary

Measure	Time frame
The secundairy parameters are safety and intake. These will be evaluated by measuring the following parameters: - Daily study product intake - Fluid intake - Occurrence of (Serious) Adverse Events - Blood parameters - Urine parameters - Paramters derived from blood and urine parameters - Blood pressure - Resting heart rate Other parameters are: - Body weight - Body Mass Index - Dietary Intake - Product appreciation (for example taste).	—

Measure

Time frame

The secundairy parameters are safety and intake. These will be evaluated by measuring the following parameters: - Daily study product intake - Fluid intake - Occurrence of (Serious) Adverse Events - Blood parameters - Urine parameters - Paramters derived from blood and urine parameters - Blood pressure - Resting heart rate Other parameters are: - Body weight - Body Mass Index - Dietary Intake - Product appreciation (for example taste).

—

Primary

Measure	Time frame
The primary parameter is tolerance. Tolerance will be evaluated by measuring the following parameters: - Daily stool frequency and consistency - Tolerance questionnaire	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)