MedTrace Logo

Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.

NCT03501290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-08-25

No results posted yet for this study

Summary

In this study, patients are supposed to take Fortimel® Protein, an Oral Nutritional Supplement (ONS) recommended in case of malnutrition once daily during the study period.

Three visits will be planned for each patient enrolled in the study (baseline visit, visits of follow-up at 4 weeks and 12 weeks). Phone calls will be regularly organized during one month or three months according to the duration of supplementation.

The primary purpose of the OFraDDom study is to assess the compliance with ONS (respect by the patient of the physician's prescription) at the end of the first month.

Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly population, are very limited. The study could complete knowledge about oral nutritional supplementation in the undernourished frail elderly people and help to demonstrate that oral nutritional supplements have benefits on nutritional status and physical performances in frail elderly people.

Conditions

  • Frail Elderly

Interventions

DIETARY_SUPPLEMENT

Fortimel® Protein supplementation

Patients are supposed to take Fortimel® Protein once daily during the study period. The prescription is one unit a day. First prescription of the study product will be done for one month. Prescription will be repeated for 2 additional months only after the patient's nutritional status and its global health status, as well as tolerability and compliance to the ONS, were re-assessed during the first follow-up visit at one month.

Sponsors & Collaborators

  • Nutricia, Inc.

    collaborator INDUSTRY

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Anne GHISOLFI, MD · Gérontopôle, CHU Toulouse

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03501290 on ClinicalTrials.gov