Clinical trial NCT04482530: Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)
Official title: Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Fruit pastes matrices
Elderly healthy volunteer
Dietary intake
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
name: Unité de recherche CSGA, INRAE Dijon
First posted: 2020-07-22
Enrollment: 15
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion.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.

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)

Primary outcomes:
measure: Area Under the Curve (AUC) of glycemia
timeFrame: Day 0
measure: Maximum Plasma Concentration (Cmax) of glycemia
timeFrame: Day 0
measure: Time of Maximum Plasma Concentration (Tmax) of glycemia
timeFrame: Day 0
measure: Area Under the Curve (AUC) of glycemia
timeFrame: Day 7
measure: Maximum Plasma Concentration (Cmax) of glycemia
timeFrame: Day 7
measure: Time of Maximum Plasma Concentration (Tmax) of glycemia
timeFrame: day 7
measure: Area Under the Curve (AUC) of glycemia
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of glycemia
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of glycemia
timeFrame: day 14
measure: Area Under the Curve (AUC) of glycemia
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of glycemia
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of glycemia
timeFrame: day 21
measure: Area Under the Curve (AUC) of glycemia
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of glycemia
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of glycemia
timeFrame: day 28
Secondary outcomes:
measure: Area Under the Curve (AUC) of fructose
timeFrame: Day 0
measure: Maximum Plasma Concentration (Cmax) of fructose
timeFrame: Day 0
measure: Time of Maximum Plasma Concentration (Tmax) of fructose
timeFrame: Day 0
measure: Area Under the Curve (AUC) of fructose
timeFrame: Day 7
measure: Maximum Plasma Concentration (Cmax) of fructose
timeFrame: Day 7
measure: Time of Maximum Plasma Concentration (Tmax) of fructose
timeFrame: Day 7
measure: Area Under the Curve (AUC) of fructose
timeFrame: Day 14
measure: Maximum Plasma Concentration (Cmax) of fructose
timeFrame: Day 14
measure: Time of Maximum Plasma Concentration (Tmax) of fructose
timeFrame: Day 14
measure: Area Under the Curve (AUC) of fructose
timeFrame: Day 21
measure: Maximum Plasma Concentration (Cmax) of fructose
timeFrame: Day 21
measure: Time of Maximum Plasma Concentration (Tmax) of fructose
timeFrame: Day 21
measure: Area Under the Curve (AUC) of fructose
timeFrame: Day 28
measure: Maximum Plasma Concentration (Cmax) of fructose
timeFrame: Day 28
measure: Time of Maximum Plasma Concentration (Tmax) of fructose
timeFrame: Day 28
measure: Area Under the Curve (AUC) of glucagon
timeFrame: day 0
measure: Maximum Plasma Concentration (Cmax) of glucagon
timeFrame: day 0
measure: Time of Maximum Plasma Concentration (Tmax) of glucagon
timeFrame: day 0
measure: Area Under the Curve (AUC) of glucagon
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of glucagon
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of glucagon
timeFrame: Day 7
measure: Area Under the Curve (AUC) of glucagon
timeFrame: Day 14
measure: Maximum Plasma Concentration (Cmax) of glucagon
timeFrame: Day 14
measure: Time of Maximum Plasma Concentration (Tmax) of glucagon
timeFrame: Day 14
measure: Area Under the Curve (AUC) of glucagon
timeFrame: Day 21
measure: Maximum Plasma Concentration (Cmax) of glucagon
timeFrame: Day 21
measure: Time of Maximum Plasma Concentration (Tmax) of glucagon
timeFrame: Day 21
measure: Area Under the Curve (AUC) of glucagon
timeFrame: Day 28
measure: Maximum Plasma Concentration (Cmax) of glucagon
timeFrame: Day 28
measure: Time of Maximum Plasma Concentration (Tmax) of glucagon
timeFrame: Day 28
measure: Area Under the Curve (AUC) of CCK
timeFrame: Day 0
measure: Maximum Plasma Concentration (Cmax) of CCK
timeFrame: Day 0
measure: Time of Maximum Plasma Concentration (Tmax) of CCK
timeFrame: Day 0
measure: Area Under the Curve (AUC) of CCK
timeFrame: Day 7
measure: Maximum Plasma Concentration (Cmax) of CCK
timeFrame: Day 7
measure: Time of Maximum Plasma Concentration (Tmax) of CCK
timeFrame: Day 7
measure: Area Under the Curve (AUC) of CCK
timeFrame: Day 14
measure: Maximum Plasma Concentration (Cmax) of CCK
timeFrame: Day 14
measure: Time of Maximum Plasma Concentration (Tmax) of CCK
timeFrame: Day 14
measure: Area Under the Curve (AUC) of CCK
timeFrame: Day 21
measure: Maximum Plasma Concentration (Cmax) of CCK
timeFrame: Day 21
measure: Time of Maximum Plasma Concentration (Tmax) of CCK
timeFrame: Day 21
measure: Area Under the Curve (AUC) of CCK
timeFrame: Day 28
measure: Maximum Plasma Concentration (Cmax) of CCK
timeFrame: Day 28
measure: Time of Maximum Plasma Concentration (Tmax) of CCK
timeFrame: Day 28
measure: Area Under the Curve (AUC) of Grehlin
timeFrame: Day 0
measure: Maximum Plasma Concentration (Cmax) of Grehlin
timeFrame: Day 0
measure: Time of Maximum Plasma Concentration (Tmax) of Grehlin
timeFrame: day 0
measure: Area Under the Curve (AUC) of Grehlin
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of Grehlin
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of Grehlin
timeFrame: day 7
measure: Area Under the Curve (AUC) of Grehlin
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of Grehlin
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of Grehlin
timeFrame: day 14
measure: Area Under the Curve (AUC) of Grehlin
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of Grehlin
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of Grehlin
timeFrame: day 21
measure: Area Under the Curve (AUC) of Grehlin
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of Grehlin
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of Grehlin
timeFrame: day 28
measure: Area Under the Curve (AUC) of leptin
timeFrame: day 0
measure: Maximum Plasma Concentration (Cmax) of leptin
timeFrame: day 0
measure: Time of Maximum Plasma Concentration (Tmax) of leptin
timeFrame: day 0
measure: Area Under the Curve (AUC) of leptin
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of leptin
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of leptin
timeFrame: day 7
measure: Area Under the Curve (AUC) of leptin
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of leptin
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of leptin
timeFrame: day 14
measure: Area Under the Curve (AUC) of leptin
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of leptin
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of leptin
timeFrame: day 21
measure: Area Under the Curve (AUC) of leptin
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of leptin
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of leptin
timeFrame: day 28
measure: Area Under the Curve (AUC) of GLP1
timeFrame: day 0
measure: Maximum Plasma Concentration (Cmax) of GLP1
timeFrame: day 0
measure: Time of Maximum Plasma Concentration (Tmax) of GLP1
timeFrame: day 0
measure: Area Under the Curve (AUC) of GLP1
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of GLP1
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of GLP1
timeFrame: day 7
measure: Area Under the Curve (AUC) of GLP1
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of GLP1
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of GLP1
timeFrame: day 14
measure: Area Under the Curve (AUC) of GLP1
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of GLP1
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of GLP1
timeFrame: day 21
measure: Area Under the Curve (AUC) of GLP1
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of GLP1
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of GLP1
timeFrame: day 28
measure: Area Under the Curve (AUC) of incretines
timeFrame: day 0
measure: Maximum Plasma Concentration (Cmax) of incretines
timeFrame: day 0
measure: Time of Maximum Plasma Concentration (Tmax) of incretines
timeFrame: day 0
measure: Area Under the Curve (AUC) of incretines
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of incretines
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of incretines
timeFrame: day 7
measure: Area Under the Curve (AUC) of incretines
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of incretines
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of incretines
timeFrame: day 14
measure: Area Under the Curve (AUC) of incretines
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of incretines
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of incretines
timeFrame: day 21
measure: Area Under the Curve (AUC) of incretines
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of incretines
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of incretines
timeFrame: day 28
measure: Area Under the Curve (AUC) of insulin
timeFrame: day 0
measure: Maximum Plasma Concentration (Cmax) of insulin
timeFrame: day 0
measure: Time of Maximum Plasma Concentration (Tmax) of insulin
timeFrame: day 0
measure: Area Under the Curve (AUC) of insulin
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of insulin
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of insulin
timeFrame: day 7
measure: Area Under the Curve (AUC) of insulin
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of insulin
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of insulin
timeFrame: day 14
measure: Area Under the Curve (AUC) of insulin
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of insulin
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of insulin
timeFrame: day 21
measure: Area Under the Curve (AUC) of insulin
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of urea
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of insulin
timeFrame: day 28
measure: Area Under the Curve (AUC) of urea
timeFrame: day 0
measure: Maximum Plasma Concentration (Cmax) of urea
timeFrame: day 0
measure: Time of Maximum Plasma Concentration (Tmax) of urea
timeFrame: day 0
measure: Area Under the Curve (AUC) of urea
timeFrame: day 7
measure: Maximum Plasma Concentration (Cmax) of urea
timeFrame: day 7
measure: Time of Maximum Plasma Concentration (Tmax) of urea
timeFrame: day 7
measure: Area Under the Curve (AUC) of urea
timeFrame: day 14
measure: Maximum Plasma Concentration (Cmax) of urea
timeFrame: day 14
measure: Time of Maximum Plasma Concentration (Tmax) of urea
timeFrame: day 14
measure: Area Under the Curve (AUC) of urea
timeFrame: day 21
measure: Maximum Plasma Concentration (Cmax) of urea
timeFrame: day 21
measure: Time of Maximum Plasma Concentration (Tmax) of urea
timeFrame: day 21
measure: Area Under the Curve (AUC) of urea
timeFrame: day 28
measure: Maximum Plasma Concentration (Cmax) of urea
timeFrame: day 28
measure: Time of Maximum Plasma Concentration (Tmax) of urea
timeFrame: day 28
measure: Questionnaire of satiety
timeFrame: at time 0 after ingestion in Day 0
measure: Questionnaire of satiety
timeFrame: at time 60 after ingestion in Day 0
measure: Questionnaire of satiety
timeFrame: at time 180 after ingestion in Day 0
measure: Questionnaire of satiety
timeFrame: at time 0 after ingestion in Day 7
measure: Questionnaire of satiety
timeFrame: at time 60 after ingestion in Day 7
measure: Questionnaire of satiety
timeFrame: at time 180 after ingestion in Day 7
measure: Questionnaire of satiety
timeFrame: at time 0 after ingestion in Day 14
measure: Questionnaire of satiety
timeFrame: at time 60 after ingestion in Day 14
measure: Questionnaire of satiety
timeFrame: at time 180 after ingestion in Day 14
measure: Questionnaire of satiety
timeFrame: at time 0 after ingestion in Day 21
measure: Questionnaire of satiety
timeFrame: at time 60 after ingestion in Day 21
measure: Questionnaire of satiety
timeFrame: at time 180 after ingestion in Day 21
measure: Questionnaire of satiety
timeFrame: at time 0 after ingestion in Day 28
measure: Questionnaire of satiety
timeFrame: at time 60 after ingestion in Day 28
measure: Questionnaire of satiety
timeFrame: at time 180 after ingestion in Day 28
measure: Questionnaire of acceptability
timeFrame: day 0
measure: Questionnaire of acceptability
timeFrame: day 7
measure: Questionnaire of acceptability
timeFrame: day 14
measure: Questionnaire of acceptability
timeFrame: day 21
measure: Questionnaire of acceptability
timeFrame: day 28
measure: Facilited individual interview
timeFrame: day 40
measure: Focus group
timeFrame: day 40
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering
role: PRINCIPAL_INVESTIGATOR
References: