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Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors (FORTIPHY)

Primary Purpose

Senior

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nutritional intervention
physical activity
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Senior

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 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.

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control

fortification (FOR)

fortification + physical activity (FAP)

Arm Description

Outcomes

Primary Outcome Measures

Weight gain or loss

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
August 31, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05739448
Brief Title
Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors
Acronym
FORTIPHY
Official Title
Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Senior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Title
fortification (FOR)
Arm Type
Experimental
Arm Title
fortification + physical activity (FAP)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
nutritional intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
physical activity
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight gain or loss
Time Frame
Through study completion, an average of 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre JOUANNY
Phone
0380293155
Ext
+33
Email
pierre.jouanny@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre JOUANNY
Phone
0380293155
Ext
+33
Email
pierre.jouanny@chu-dijon.fr

12. IPD Sharing Statement

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Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors

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