Effect of High Protein, High-calorie Oral Nutritional Sup... | NCT03083912

Studies
Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.

NCT03083912

Sponsor

Hospital Viamed Valvanera, Spain

Status

Completed

Last Update Posted

Nov 28, 2017Actual

Enrollment

291Actual

Phase

Not provided

Conditions

Other Malnutrition

Interventions

Fortimel Complete

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Oct 25, 2016

First Submission Date that Met QC Criteria

Mar 13, 2017

First Posted Date

Mar 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2017

Last Update Posted Date

Nov 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincenzo Malafarina, MD MSc, MD, MSc, PhD3, University of NavarraPrincipal Investigator

Lead Sponsor

Hospital Viamed Valvanera, SpainOTHER

Collaborators

Name	Class
Hospital Universitario Ramon y Cajal	OTHER
Hospital General Universitario Gregorio Marañon	OTHER
Hospital Clinic of Barcelona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in Spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.

Detailed Description

A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

291Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fortimel Complete		All of the residents included receive ONS	Dietary Supplement: Fortimel Complete

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fortimel Complete	Dietary Supplement	The residents included receive 2 bottle por day.	Fortimel Complete

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improve weight	Difference between the weight of the residents at the beginning and at the end of the study	3 months

Secondary Outcomes

Measure	Description	Time Frame
SPPB scale	Functional status at the end of the study	3 months
Barthel index	Ability in Activities of Daily Living at the end of the study

Other Outcomes

Measure	Description	Time Frame
Number of drinking bottles during the study.	Evaluate the compliance with the oral nutritional supplementation	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than or equal to 65 years,
Living in nursing homes,
Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).

Exclusion Criteria:

Tube feeding (nasogastric or gastrostomy)
Terminally ill or palliative treatment and residents with life expectancy of less than 6 months
Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Malnourished elderly living in nursing homes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nuria Fernandez Bodas	Nutricia, Inc.	Study Chair
Alfonso Cruz Jentoft, MD PhD	Head of Geriatric Department, Hospital Universitario Ramón y Cajal	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Ramón y Cajal		Madrid		28034	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23415063	Background	Malafarina V, Uriz-Otano F, Gil-Guerrero L, Iniesta R. The anorexia of ageing: physiopathology, prevalence, associated comorbidity and mortality. A systematic review. Maturitas. 2013 Apr;74(4):293-302. doi: 10.1016/j.maturitas.2013.01.016. Epub 2013 Feb 13.
24246053	Background	van Nie-Visser NC, Meijers J, Schols J, Lohrmann C, Bartholomeyczik S, Spreeuwenberg M, Halfens R. Which characteristics of nursing home residents influence differences in malnutrition prevalence? An international comparison of The Netherlands, Germany and Austria. Br J Nutr. 2014 Mar 28;111(6):1129-36. doi: 10.1017/S0007114513003541. Epub 2013 Nov 18.

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases