SeniorFORTIPHYNCT05739448
Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors
A study testing nutritional intervention and physical activity in people with Senior, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In the context of an aging population, preventing undernutrition and its associated risks in the elderly is a major challenge for the coming decade. Undernutrition, a recognized pathology of the elderly, has many negative impacts on the health and well-being of a person. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Senior
- What is being tested?
- nutritional intervention and physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 27 Sep 2023
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Person over 70 years of age
- Person living at home or in a relative's home
- Person with low level of physical activity (no more than 30 minutes of exercise for at least 2 days per week)
Who cannot join
- Person with a prescription for an oral nutritional supplement
- Anyone with allergies or intolerances to foods/ingredients used in the fortified foods
- Anyone with an aversion to fish
- Anyone on a restrictive diet or vegan/vegetarian diet
- Persons on a texture modified diet (blended, pureed)
- Person requiring enteral or parenteral nutrition
Show all 21Show fewer
- Person suffering from dysphagia
- Person in a wheelchair
- Persons on special diets (texture modified, enteral, parenteral)
- Person under legal protection (guardianship, trusteeship)
- Person under a legal protection measure
- A person who is incapable or unable to give consent
- Person who is not affiliated or not a beneficiary of a social security system
- Person in a period of exclusion from a previous study
- Secondary exclusion criteria :
- Person who is malnourished (MNA Long-Form score < 17)
- Person with low cognitive abilities (MMSE < 20) without a caregiver
- Person with a BMI ≥ 35 kg/m2
- Person with balance disorders (Get up and Go test execution time > 20 seconds or time in unipodal balance < 5 seconds).
- Person suffering from an acute pathology that can influence the vital prognosis (cancer, renal failure with dialysis...)
- Person suffering from chronic neuropsychological disorders altering the decisional capacities without the help of a close relative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors : a Randomized Controlled Trial
In the context of an aging population, preventing undernutrition and its associated risks in the elderly is a major challenge for the coming decade. Undernutrition, a recognized pathology of the elderly, has many negative impacts on the health and well-being of a person. It increases the risk of falls, fractures, pathological episodes and hospitalizations. It induces or aggravates a state of frailty and dependence, ultimately affecting the quality of life and life expectancy of the elderly.
A decline in appetite and insufficient food intake are key factors in the risk of undernutrition. Contrary to popular belief, energy and protein requirements do not decrease with age and are sometimes higher for the elderly than for younger people. However, several studies have shown that caloric and protein intakes are lower than recommended for the elderly. This decrease in appetite is also accompanied by a decrease in micronutrient intake. Inadequate micronutrient intakes are associated with the onset or more rapid progression of age-related diseases. For example, inadequate intakes of lipophilic micronutrients (carotenoids, fat-soluble vitamins A, D and E, long-chain omega-3 polyunsaturated fatty acids) are associated with a more rapid onset or worsening of age-related macular degeneration (AMD).
Read more
In order to prevent undernutrition, a major challenge is to allow elderly people with a poor appetite to cover their nutritional needs. Meal fortification, which consists of adding ingredients with high nutritional value to foods and beverages commonly consumed by the elderly, is a promising strategy. It allows for better adaptation to the preferences of the elderly, who are often reluctant to change their consumption habits. However, meal fortification remains largely unknown and underutilized. In parallel, several studies have shown that a high adherence to the Mediterranean diet, which is characterized by a high intake of these micronutrients, is associated with a 40% reduction in the risk of progression to AMD.
Finally, there is a strong link between physical activity and nutrition to prevent muscle wasting in the elderly. Indeed, the results show that an intervention combining protein supplementation and physical exercise has a greater effect on muscle protein synthesis than protein supplementation alone. However, advancing age is frequently accompanied by a decrease in physical activity and an increase in sedentary lifestyle.
- Conditions
- Senior
- Being tested
- nutritional intervention, physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionOther
The nutritional intervention will be based on the following 4 elements: nutritional follow-up by a dietician, fortified meals, tender and juicy meat dishes and fish dishes
physical activityOther
The physical activity intervention will be based on the following 2 elements: Follow-up with a trainer for adapted exercise and physical exercise instruction sheets
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| fortification (FOR) | Experimental | Not described Receives: Other: nutritional intervention |
| fortification + physical activity (FAP) | Experimental | Not described Receives: Other: nutritional intervention; Other: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain or loss
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Mar 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeniorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739448
- Sponsor's protocol ID
- VAN WYMELBEKE ERA 2020
- Acronym
- FORTIPHY
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05739448
- Acronym / sponsor ID
- FORTIPHY / VAN WYMELBEKE ERA 2020
- Conditions
- Senior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 22 Feb 2023 (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 the context of an aging population, preventing undernutrition and its associated risks in the elderly is a major challenge for the coming decade. Undernutrition, a recognized pathology of the elderly, has many negative impacts on the health and well-being of a person. It increases the risk of falls, fractures, pathological episodes and hospitalizations. It induces or aggravates a state of frailty and dependence, ultimately affecting the quality of life and life expectancy of the elderly.
A decline in appetite and insufficient food intake are key factors in the risk of undernutrition. Contrary to popular belief, energy and protein requirements do not decrease with age and are sometimes higher for the elderly than for younger people. However, several studies have shown that caloric and protein intakes are lower than recommended for the elderly. This decrease in appetite is also accompanied by a decrease in micronutrient intake. Inadequate micronutrient intakes are associated with the onset or more rapid progression of age-related diseases. For example, inadequate intakes of lipophilic micronutrients (carotenoids, fat-soluble vitamins A, D and E, long-chain omega-3 polyunsaturated fatty acids) are associated with a more rapid onset or worsening of age-related macular degeneration (AMD).
In order to prevent undernutrition, a major challenge is to allow elderly people with a poor appetite to cover their nutritional needs. Meal fortification, which consists of adding ingredients with high nutritional value to foods and beverages commonly consumed by the elderly, is a promising strategy. It allows for better adaptation to the preferences of the elderly, who are often reluctant to change their consumption habits. However, meal fortification remains largely unknown and underutilized. In parallel, several studies have shown that a high adherence to the Mediterranean diet, which is characterized by a high intake of these micronutrients, is associated with a 40% reduction in the risk of progression to AMD.
Finally, there is a strong link between physical activity and nutrition to prevent muscle wasting in the elderly. Indeed, the results show that an intervention combining protein supplementation and physical exercise has a greater effect on muscle protein synthesis than protein supplementation alone. However, advancing age is frequently accompanied by a decrease in physical activity and an increase in sedentary lifestyle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| fortification (FOR) | Experimental | Other: nutritional intervention |
| fortification + physical activity (FAP) | Experimental | Other: nutritional intervention, Other: physical activity |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Person over 70 years of age
- Person living at home or in a relative's home
- Person with low level of physical activity (no more than 30 minutes of exercise for at least 2 days per week)
Key exclusion criteria (21 listed)
- Person with a prescription for an oral nutritional supplement
- Anyone with allergies or intolerances to foods/ingredients used in the fortified foods
- Anyone with an aversion to fish
- Anyone on a restrictive diet or vegan/vegetarian diet
- Persons on a texture modified diet (blended, pureed)
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 |
|---|---|---|
| nutritional interventionThe nutritional intervention will be based on the following 4 elements: nutritional follow-up by a dietician, fortified meals, tender and juicy meat dishes and fish dishes | Other | fortification (FOR), fortification + physical activity (FAP) |
| physical activityThe physical activity intervention will be based on the following 2 elements: Follow-up with a trainer for adapted exercise and physical exercise instruction sheets | Other | fortification + physical activity (FAP) |
Primary outcome
Weight gain or loss
Time frame: Through study completion, an average of 4 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 22 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention and physical activity in people with Senior, run by Centre Hospitalier Universitaire Dijon 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 3 inclusion and 21 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 22 Feb 2024. 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?
Weight gain or loss (time frame: Through study completion, an average of 4 months). 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 22 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.