An Oral Nutritional Supplement Study in Older Malnourished Spanish Population

Malnutrition Clinical Trial

Official title:

A Prospective, Observational Study, of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished Spanish Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02404987
• Other study ID #: DA07
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2015
• Last updated: March 27, 2015
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2015
• Source: Abbott Nutrition
• Contact: Kristen DeLuca, MS, RD
• Phone: 614-624-5455
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Health authority: Spain: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study.

• Considered malnourished, or is at risk for malnutrition based on NRS 2002 score =3.

• =65 years of age.

• Conforms to the requirements set forth on the study product label.

• Under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/d of the study ONS, orally, by their health care professional.

• Free living or residing in a nursing home.

• Estimated, or measured, glomerular filtration rate >60ml/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) Study equation) within 60 days of beginning their nutritional care plan.

• Body mass index (BMI) is <30 kg/m2.

• Study physician determines the subject is fit to participate.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Nutritional Supplement

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		Change from baseline to 12 weeks	No
Secondary	Body Mass Index (BMI)	BMI will be calculated: weight (kg)/ height (cm)^2	Change from baseline to 12 weeks	No
Secondary	Katz Activities of Daily Living	A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding.	Change from baseline to 12 weeks	No
Secondary	Quality of Life	EQ5D, self-reported quality of life tool	Change from baseline to 12 weeks	No