Powdered Fermented Fruits for Glycemia Reduction

NCT04877548 | Unknown

• 1 other identifier: 69HCL20_1032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Risk Factors; Obesity, Abdominal

Keywords

Postprandial glycaemia; Dietary fibers; Cardiometabolic risk; Fermented fruit flour

Outcome Measures

Primary Outcomes (1)

• 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).

  Through study completion, an average of 18 days

Secondary Outcomes (14)

• 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

  Through study completion, an average of 18 days

• Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)

  Through study completion, an average of 18 days

• 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)

  Through study completion, an average of 18 days

• Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)

  Through study completion, 24 hours following the last day

• Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis

  Through study completion, an average of 18 days

Study Arms (3)

Fermented orange flour

EXPERIMENTAL

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

Other: Fermented orange flour

Fermented grape flour

EXPERIMENTAL

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

Other: Fermented grape flour

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

Fermented orange flour OTHER

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

Fermented orange flour

Fermented grape flour OTHER

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

Fermented grape flour

Control OTHER

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

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, France

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie FEUGIER-FAVIER, MD

  Centre de Recherche en Nutrition Humaine Rhône-Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie FEUGIER-FAVIER, MD

CONTACT

4 78 86 19 72; nathalie.feugier@chu-lyon.fr

Julie-Anne NAZARE, PhD

CONTACT

4 78 86 23 22; julie-anne.nazare@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 7, 2021
• Study Start: September 7, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

FR (1)