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

NCT04482530 | Completed

• 2 other identifiers: RBHP 2019 PICKERING2019-A00995-52
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Fruit pastes matrices; Elderly healthy volunteer; Dietary intake

Outcome Measures

Primary Outcomes (15)

• Area Under the Curve (AUC) of glycemia

  Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  Day 0

• Maximum Plasma Concentration (Cmax) of glycemia

  Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  Day 0

• Time of Maximum Plasma Concentration (Tmax) of glycemia

  Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  Day 0

• Area Under the Curve (AUC) of glycemia

  Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  Day 7

• Maximum Plasma Concentration (Cmax) of glycemia

  Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  Day 7

• Time of Maximum Plasma Concentration (Tmax) of glycemia

  Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 7

• Area Under the Curve (AUC) of glycemia

  Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 14

• Maximum Plasma Concentration (Cmax) of glycemia

  Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 14

• Time of Maximum Plasma Concentration (Tmax) of glycemia

  Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 14

• Area Under the Curve (AUC) of glycemia

  Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 21

• Maximum Plasma Concentration (Cmax) of glycemia

  Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 21

• Time of Maximum Plasma Concentration (Tmax) of glycemia

  Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 21

• Area Under the Curve (AUC) of glycemia

  Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 28

• Maximum Plasma Concentration (Cmax) of glycemia

  Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  day 28

• Time of Maximum Plasma Concentration (Tmax) of glycemia

  Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  day 28

Secondary Outcomes (157)

• Area Under the Curve (AUC) of fructose

  Day 0

• Maximum Plasma Concentration (Cmax) of fructose

  Day 0

• Time of Maximum Plasma Concentration (Tmax) of fructose

  Day 0

• Area Under the Curve (AUC) of fructose

  Day 7

• Maximum Plasma Concentration (Cmax) of fructose

  Day 7

Study Arms (5)

Original recipe

EXPERIMENTAL

Normal fruit paste

Other: fruit paste matrice

maltodextrin recipe

EXPERIMENTAL

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

Other: fruit paste matrice

fructose recipe

EXPERIMENTAL

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

Other: fruit paste matrice

isomaltulose recipe

EXPERIMENTAL

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

Other: fruit paste matrice

mixed recipe

EXPERIMENTAL

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

Other: fruit paste matrice

Interventions

fruit paste matrice 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.

Original recipe; fructose recipe; isomaltulose recipe; maltodextrin recipe; mixed recipe

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes: collaborator
• Unité de recherche CSGA, INRAE Dijon: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Study Officials

• Gisèle Pickering

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Same flavor will be used for all matrices. The different matrices will be offered to volunteers in in individual packaged portions.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 22, 2020
• Study Start: May 31, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 19, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

FR (1)