Frail Elderly Clinical Trial
Official title:
Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.
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.
For elderly with Protein Energy Malnutrition (PEM) or at nutritional risk, evidences support
that Oral Nutritional Supplements (ONS) and dietary counselling can increase dietary intake
and improve quality of life. However, data regarding the beneficial effects of ONS, or
compliance with ONS in frail elderly population, are very limited. In their RCT, testing the
effect of protein supplementation, Tieland and colleagues (7) showed an improvement of SPPB
in frail older adults randomized to receive 15 g of supplemental protein daily for 24 weeks
compared with the placebo group (p=0.02). Another recent RCT on the effect of a daily
supplementation with protein and micronutrients for 12 weeks in 87 frail older adults (usual
gait speed <0.6 m/s; MNA < 24) showed that Physical Functioning increased by 5.9% (1 point)
in the intervention group, although no change was observed in the control group. SPPB
remained stable in the intervention group, although it decreased by 12.5% (1 point) in
controls (8).
In this study, patients are supposed to take Fortimel® Protein, an ONS recommended in case of
malnutrition once daily during the study period.
Patients fulfilling eligibility criteria will be asked whether they are interested to
participate in the study and receive Fortimel® protein. After informed consent, 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
month according to the duration of supplementation to collect the compliance with ONS and
coach patients.
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.
Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly
population, are very limited. To complete knowledge about oral nutritional supplementation in
the undernourished frail elderly people, study purpose is to assess Fortimel® Protein
compliance to know if this supplementation is well accepted and what are factors which limit
compliance. More, it could help to demonstrate that oral nutritional supplements have
benefits on nutritional status and physical performances in frail elderly people.
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