Status:
COMPLETED
Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
Unité de recherche CSGA, INRAE Dijon
Conditions:
Healthy
Eligibility:
MALE
65+ years
Phase:
NA
Brief Summary
To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.
Detailed Description
This is an interventional randomized, single blinded, cross over and controlled study. The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched ...
Eligibility Criteria
Inclusion
- Male subject
- Subject over 65 years (included)
- Subject over 61 kg (included)
- Able to consume the 80g of fruit pastes in 10 minutes
- Subject with a dentition consistent with the fruit paste consumption in 10 minutes
- Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2
- Subject agreeing to provide written consent
Exclusion
- Subject with acute pathology (unstable or terminal pathology, severe dementia)
- Subject with renal failure (clearance \< 60 ml/min)
- Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l)
- Person with diabetes
- Subject on food restriction
- Subject undergoing chemotherapy
- Subject with gastrointestinal pathology
- Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04482530
Start Date
May 31 2021
End Date
July 19 2021
Last Update
September 27 2022
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000