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

NCT03501290 | Completed

• 2 other identifiers: RC31/15/78142015-A01870-49
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Frailty; Malnutrition; Older adults; Oral Nutritional Supplements; Compliance

Outcome Measures

Primary Outcomes (1)

• Fortimel® compliance

  Fortimel® compliance as defined as the consumption of at least 75% of the prescribed volume of ONS.

  At the end of the first month : Day 30

Secondary Outcomes (8)

• Fortimel® Compliance

  Change at one and three months

• Body weight evolution

  Change at one and three months

• SPPB score

  Change at one and three months

• MNA

  Change at one and three months

• ADL

  Change at one and three months

Study Arms (1)

Oral Nutritional Supplement Group

OTHER

All patients will be in one group, receiving the active product, Oral Nutritional Supplement with 'Fortimel® Protein supplementation'

Dietary Supplement: Fortimel® Protein supplementation

Interventions

Fortimel® Protein supplementation DIETARY_SUPPLEMENT

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.

Oral Nutritional Supplement Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community dwelling
• Pre-frail or frail as defined by Fried criteria: at least a low score on one of the following:
• Weight loss
• Exhaustion
• Physical Activity
• Walk time
• Grip strength
• Undernutrition defined as at least one of the following criteria :
• weight loss (≥ 5% in 1 month or ≥ 10% in 6 months),
• BMI \< 21 kg/m2
• or global MNA \<23.5
• Informed consent
• Willingness and ability to comply with the protocol, including:
• Participation in study visits
• Taking the study products every day

You may not qualify if:

• Dependency or loss of autonomy: ADL\<4
• Dementia
• MMSE ≤ \<20 if study partner, MMSE\<22 if loss of study partner
• Use of enteral nutrition
• Major depression: Geriatric Depression Scale \>8
• Cancer with acute treatment (chemotherapy, radiotherapy)
• Allergy to cow milk proteins
• Galactosemia
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Nutricia, Inc.: collaborator

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Frailty; Malnutrition; Patient Compliance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anne GHISOLFI, MD

  Gérontopôle, CHU Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will be in one group, receiving the product.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: April 18, 2018
• Study Start: June 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

FR (1)