search
Back to results

Powdered Fermented Fruits for Glycemia Reduction (P2F-GR)

Primary Purpose

Cardiometabolic Risk Factors, Obesity, Abdominal

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fermented orange flour
Fermented grape flour
Control
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiometabolic Risk Factors focused on measuring Postprandial glycaemia, Dietary fibers, Cardiometabolic risk, Fermented fruit flour

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body Mass Index between 25 and 35 kg/m2 inclusive
  • Waist circumference > 80 cm for women and > 96 cm for men
  • Fibers intake ≤ 25g/day

Exclusion Criteria:

  • History of digestive surgery or diseases
  • Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
  • Current probiotics, prebiotics, fibers complement, and/or any products modulating glucose and lipid metabolism
  • Volunteer with a dietary restriction (vegetarian or high-protein diet for example)
  • Current weight loss diet
  • Pregnant or lactating woman or woman who do not use effective contraception
  • Drinking more than 3 glasses of alcohol per day (>30g/day)
  • Smoking volunteer

Sites / Locations

  • Centre de Recherche en Nutrition Humaine Rhône-AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Fermented orange flour

Fermented grape flour

Control

Arm Description

Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates

Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates

Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates

Outcomes

Primary Outcome Measures

Incremental area under curve (iAUC 0-240 min) of postprandial glycaemia in response to an acute intake of different standardized breakfast including or not a fermented fruits flour but which all contain similar amount of available carbohydrate.
Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).

Secondary Outcome Measures

Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of glycaemia and insulinemia
Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)
Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of digestive hormones (GLP-1 and ghrelin)
GLP-1 and ghrelin concentrations will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 and t0, 60, 120, 180, 240 respectively (when taking the standardized breakfast).
Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)
Expired gases concentrations will be measured at time t-30, 0, 60, 120, 180, 240, 360, 480, before the diner and the breakfast next day (24 hours following the standardized breakfast intake).
Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis
Indirect calorimetry measurement during the postprandial period (0-240 min) (when taking the standardized breakfast).
Satiety and digestive tolerance
Visual analogue scales (VAS) on gastrointestinal symptoms and questionnaires on the consistency and frequency of stools completed, when taking the standardized breakfast (24 hours following the standardized breakfast intake).
Baseline characteristics
Anthropometric parameters height (cm), waist and hip circumference (cm),
Dietary intake
Dietary records completed (the day before and the day of the standardized breakfast intake).
Baseline characteristics
Anthropometric parameters: - weight (kg)
Baseline characteristics
Anthropometric parameters: - body composition (lean body mass and fat mass by impedance)
Baseline characteristics
Metabolic parameters (glycaemia, insulinemia).
Baseline characteristics
Digestive hormones (GLP-1, ghrelin)
Baseline characteristics
Expired gases (H2, CH4)
Baseline characteristics
Resting metabolic rate.

Full Information

First Posted
April 26, 2021
Last Updated
September 13, 2021
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT04877548
Brief Title
Powdered Fermented Fruits for Glycemia Reduction
Acronym
P2F-GR
Official Title
Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the effects of an acute intake of two fermented fruits flours as part of a standardized breakfast, in comparison with the acute intake of a standardized breakfast without fermented fruits flour but with the same amount of available carbohydrates, on postprandial glycaemic response and overall metabolism in subjects at cardiometabolic risk. The metabolic parameters will be assessed in fasting and in postprandial period after the consumption of the standardized breakfast.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Risk Factors, Obesity, Abdominal
Keywords
Postprandial glycaemia, Dietary fibers, Cardiometabolic risk, Fermented fruit flour

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fermented orange flour
Arm Type
Experimental
Arm Description
Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
Arm Title
Fermented grape flour
Arm Type
Experimental
Arm Description
Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
Intervention Type
Other
Intervention Name(s)
Fermented orange flour
Intervention Description
Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
Intervention Type
Other
Intervention Name(s)
Fermented grape flour
Intervention Description
Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
Primary Outcome Measure Information:
Title
Incremental area under curve (iAUC 0-240 min) of postprandial glycaemia in response to an acute intake of different standardized breakfast including or not a fermented fruits flour but which all contain similar amount of available carbohydrate.
Description
Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Time Frame
Through study completion, an average of 18 days
Secondary Outcome Measure Information:
Title
Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of glycaemia and insulinemia
Description
Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Time Frame
Through study completion, an average of 18 days
Title
Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)
Description
Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Time Frame
Through study completion, an average of 18 days
Title
Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of digestive hormones (GLP-1 and ghrelin)
Description
GLP-1 and ghrelin concentrations will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 and t0, 60, 120, 180, 240 respectively (when taking the standardized breakfast).
Time Frame
Through study completion, an average of 18 days
Title
Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)
Description
Expired gases concentrations will be measured at time t-30, 0, 60, 120, 180, 240, 360, 480, before the diner and the breakfast next day (24 hours following the standardized breakfast intake).
Time Frame
Through study completion, 24 hours following the last day
Title
Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis
Description
Indirect calorimetry measurement during the postprandial period (0-240 min) (when taking the standardized breakfast).
Time Frame
Through study completion, an average of 18 days
Title
Satiety and digestive tolerance
Description
Visual analogue scales (VAS) on gastrointestinal symptoms and questionnaires on the consistency and frequency of stools completed, when taking the standardized breakfast (24 hours following the standardized breakfast intake).
Time Frame
Through study completion, 24 hours following the last day
Title
Baseline characteristics
Description
Anthropometric parameters height (cm), waist and hip circumference (cm),
Time Frame
Day 0 (at fasting before the standardized breakfast intake)
Title
Dietary intake
Description
Dietary records completed (the day before and the day of the standardized breakfast intake).
Time Frame
Through study completion, an average of 18 days
Title
Baseline characteristics
Description
Anthropometric parameters: - weight (kg)
Time Frame
Day 0 (at fasting before the standardized breakfast intake)
Title
Baseline characteristics
Description
Anthropometric parameters: - body composition (lean body mass and fat mass by impedance)
Time Frame
Day 0 (at fasting before the standardized breakfast intake)
Title
Baseline characteristics
Description
Metabolic parameters (glycaemia, insulinemia).
Time Frame
Day 0 (at fasting before the standardized breakfast intake)
Title
Baseline characteristics
Description
Digestive hormones (GLP-1, ghrelin)
Time Frame
Day 0 (at fasting before the standardized breakfast intake)
Title
Baseline characteristics
Description
Expired gases (H2, CH4)
Time Frame
Day 0 (at fasting before the standardized breakfast intake)
Title
Baseline characteristics
Description
Resting metabolic rate.
Time Frame
Day 0 (at fasting before the standardized breakfast intake)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body Mass Index between 25 and 35 kg/m2 inclusive Waist circumference > 80 cm for women and > 96 cm for men Fibers intake ≤ 25g/day Exclusion Criteria: History of digestive surgery or diseases Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product Current probiotics, prebiotics, fibers complement, and/or any products modulating glucose and lipid metabolism Volunteer with a dietary restriction (vegetarian or high-protein diet for example) Current weight loss diet Pregnant or lactating woman or woman who do not use effective contraception Drinking more than 3 glasses of alcohol per day (>30g/day) Smoking volunteer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie FEUGIER-FAVIER, MD
Phone
4 78 86 19 72
Ext
+33
Email
nathalie.feugier@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie-Anne NAZARE, PhD
Phone
4 78 86 23 22
Ext
+33
Email
julie-anne.nazare@univ-lyon1.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie FEUGIER-FAVIER, MD
Organizational Affiliation
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine Rhône-Alpes
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie FEUGIER-FAVIER, MD

12. IPD Sharing Statement

Learn more about this trial

Powdered Fermented Fruits for Glycemia Reduction

We'll reach out to this number within 24 hrs