NCT02873897

Brief Summary

In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies. For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment. Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

August 22, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

August 4, 2016

Last Update Submit

August 16, 2016

Conditions

Keywords

elderly

Outcome Measures

Primary Outcomes (1)

  • Measuring new product satisfaction

    Measure satisfaction with new products developed and chosen for elderly people living at home with meals-on wheels or in EHPAD (old people's homes)

    throughout the study; completion up to 13 months

Study Arms (2)

Group "meals on wheels at home"

OTHER
Dietary Supplement: Experimental session: to select enriched productsDietary Supplement: Control session

Group "residents of old people's homes - EHPAD

OTHER
Dietary Supplement: Session A: Experimental products (selected enriched products)Dietary Supplement: Session B: Control (standard products without enrichment)

Interventions

Group "residents of old people's homes - EHPAD
Group "meals on wheels at home"
Group "residents of old people's homes - EHPAD
Control sessionDIETARY_SUPPLEMENT
Group "meals on wheels at home"

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • people older than 65 years
  • persons living in EHPAD-type old people's homes or living at home and using a meals-on-wheels service
  • persons without known heart disease or arterial hypertension
  • persons who have given oral consent

You may not qualify if:

  • Persons suffering from a serious illness during the trial
  • Persons with life expectancy of less than 6 months
  • Persons with proven anosmia (total loss of olfaction), from birth or because of physical trauma (head injury) or disease (acute rhinitis)
  • Persons with an allergy or an aversion for any of the foods used
  • Persons with a strict prescribed diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

Central Study Contacts

Patrick MANCKOUNDIA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 22, 2016

Study Start

December 1, 2015

Primary Completion

February 1, 2017

Last Updated

August 22, 2016

Record last verified: 2016-07

Locations