Micronutrient & Malnourished Elderly NCT02396121

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study information
Verified date	February 2015
Source	Nestlé
Contact	n/a
Is FDA regulated	No
Health authority	France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type	Interventional

The purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.

Recruitment information / eligibility
Status	Completed
Enrollment	67
Est. completion date	June 2014
Est. primary completion date	June 2014
Accepts healthy volunteers	No
Gender	Both
Age group	70 Years and older
Eligibility	Inclusion Criteria: - Age : above or equal to 70 years AND : - Weight loss above or equal to 5% in one month - OR weight loss above or equal to 10% in 6 months - OR BMI between 18 and 21 - OR albuminaemia between 30 and 35 g/L - OR MNA-SF less or equal to 7 Exclusion Criteria: - Severe malnutrition - Contraindication to oral nutrition - Severe pathologies - Inflammatory syndrome (CRP > 30 mg/L) - Severe dementia (Mini Mental Score < 10)

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Dietary Supplement:
• Oral nutritional supplement : Renutryl® Booster

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Nestlé

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in micronutrients status after 28 days	Biological analyses of micronutrient	28 days	No
Secondary	Nutritional status	Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)	28 days	No
Secondary	Body composition	Impedance measurement	28 days	No
Secondary	Compliance	Compliance measured by bottle weight before and after consumption	28 days	No
Secondary	Autonomy	"Get up and go" test	28 fays	No