Frail ElderlyOFraDDomNCT03501290
Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.
A study testing Fortimel® Protein supplementation in people with Frail Elderly, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Fortimel® Protein supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
- Ability to perform test for physical functioning and frailty status
- Ability to understand and fill out questionnaires
Who cannot join
- 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)
Show all 9Show fewer
- Allergy to cow milk proteins
- Galactosemia
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Frail Elderly
- Being tested
- Fortimel® Protein supplementation
- Keywords
- Frailty, Malnutrition, Older adults, Oral Nutritional Supplements, Compliance
- Medical subject headings
- Frailty, Malnutrition, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortimel® Protein supplementationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement Group | Other | All patients will be in one group, receiving the active product, Oral Nutritional Supplement with 'Fortimel® Protein supplementation' Receives: Dietary Supplement: Fortimel® Protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fortimel® compliance
Fortimel® compliance as defined as the consumption of at least 75% of the prescribed volume of ONS.
Measured: At the end of the first month : Day 30
Secondary outcomes (8)
Fortimel® Compliance
Fortimel® Compliance as defined as the consumption of at least 75% of the prescribed volume of ONS after 3 months supplementation,
Measured: Change at one and three months
Body weight evolution
Body weight evolution measured during the follow up visits at one month and three months,
Measured: Change at one and three months
SPPB score
Short Physical Performance Battery (SPPB) score (global score and each item)
Measured: Change at one and three months
MNA
MNA scores evolution
Measured: Change at one and three months
ADL
ADL scores evolution
Measured: Change at one and three months
Fragility : Fried criteria
Fragility : Fried criteria evolution
Measured: Change at one and three months
EuroQoL
EuroQoL scores evolution
Measured: Change at one and three months
Nutritional history intake
Nutritional history intake evolution
Measured: Change at one and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jun 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will be in one group, receiving the product.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia, Inc.
- Responsible party
- Sponsor
- Investigators
- Anne GHISOLFI, MD, Principal investigator, Gérontopôle, CHU Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501290
- Sponsor's protocol ID
- RC31/15/7814
- Other IDs
- 2015-A01870-49
- Acronym
- OFraDDom
- Status last verified
- Aug 2020
- First submitted
- 13 Nov 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.
- ClinicalTrials.gov ID
- NCT03501290
- Acronym / sponsor ID
- OFraDDom / RC31/15/7814
- Conditions
- Frail Elderly
- Keywords
- Frailty, Malnutrition, Older adults, Oral Nutritional Supplements, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Nutricia, Inc.
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will be in one group, receiving the product.
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement Group | Other | Dietary Supplement: Fortimel® Protein supplementationAll patients will be in one group, receiving the active product, Oral Nutritional Supplement with 'Fortimel® Protein supplementation' |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- Community dwelling
- Pre-frail or frail as defined by Fried criteria: at least a low score on one of the following:
- Undernutrition defined as at least one of the following criteria :
- Informed consent
- Willingness and ability to comply with the protocol, including:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortimel® Protein supplementationPatients 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. | Dietary supplement | Oral Nutritional Supplement Group |
Primary outcome
Fortimel® compliance
Time frame: At the end of the first month : Day 30
Fortimel® compliance as defined as the consumption of at least 75% of the prescribed volume of ONS.
8 secondary outcomes
Fortimel® Compliance
Time frame: Change at one and three months
Body weight evolution
Time frame: Change at one and three months
SPPB score
Time frame: Change at one and three months
MNA
Time frame: Change at one and three months
ADL
Time frame: Change at one and three months
Fragility : Fried criteria
Time frame: Change at one and three months
EuroQoL
Time frame: Change at one and three months
Nutritional history intake
Time frame: Change at one and three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne GHISOLFI, MD principal investigator
Gérontopôle, CHU Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortimel® Protein supplementation in people with Frail Elderly, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fortimel® compliance (time frame: At the end of the first month : Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.