Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)

NCT ID: NCT04482530

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2021-07-19

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 in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars.

The secondary objective is:

-the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7)

• Informed consent form
• Clinical examination
• Medical history
• Anthropometric characteristics
• Blood biochemical and hematological assessment
• Compliance test with the original matrix will be carried out

Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods.

Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix.

After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below).

Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method.

Visit 7 will be the last visit of the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Original recipe

Normal fruit paste

Group Type: EXPERIMENTAL

fruit paste matrice

Intervention Type: OTHER

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

maltodextrin recipe

fruit pastes in which some of the simple sugars in the recipe will be replaced by maltodextrin with a low glycemic index (DE12).

Group Type: EXPERIMENTAL

fruit paste matrice

Intervention Type: OTHER

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

fructose recipe

fruit pastes in which some of the simple sugars in the recipe (25% min) will be replaced by fructose

Group Type: EXPERIMENTAL

fruit paste matrice

Intervention Type: OTHER

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

isomaltulose recipe

fruit pastes with some of the sugars will be replaced (25% min) by isomaltulose

Group Type: EXPERIMENTAL

fruit paste matrice

Intervention Type: OTHER

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

mixed recipe

fruit pastes with some of the sugars will be replaced (25% min) by fructose / isomaltulose

Group Type: EXPERIMENTAL

fruit paste matrice

Intervention Type: OTHER

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Interventions

fruit paste matrice

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes

UNKNOWN

Sponsor Role: collaborator

Unité de recherche CSGA, INRAE Dijon

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle Pickering

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2019-A00995-52

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 PICKERING

Identifier Type: -

Identifier Source: org_study_id