Cardiometabolic Risk FactorsP2F-GRNCT04877548
Powdered Fermented Fruits for Glycemia Reduction
A study testing Fermented orange flour and Fermented grape flour in people with Cardiometabolic Risk Factors and Obesity, Abdominal, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors, Obesity, Abdominal
- What is being tested?
- Fermented orange flour and Fermented grape flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite
Nathalie FEUGIER-FAVIER, MD
About this study
Official title: Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile
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
- Being tested
- Fermented orange flour, Fermented grape flour, Control
- Keywords
- Postprandial glycaemia, Dietary fibers, Cardiometabolic risk, Fermented fruit flour
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented orange flourOther
Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
Fermented grape flourOther
Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
ControlOther
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Fermented orange flour | Experimental | Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates Receives: 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 Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Measured: Through study completion, an average of 18 days
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: Through study completion, 24 hours following the last day
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).
Measured: Through study completion, an average of 18 days
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).
Measured: Through study completion, 24 hours following the last day
Baseline characteristics
Anthropometric parameters
- height (cm),
- waist and hip circumference (cm),
Measured: Day 0 (at fasting before the standardized breakfast intake)
Dietary intake
Dietary records completed (the day before and the day of the standardized breakfast intake).
Measured: Through study completion, an average of 18 days
Baseline characteristics
Anthropometric parameters:
- weight (kg)
Measured: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Anthropometric parameters:
- body composition (lean body mass and fat mass by impedance)
Measured: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Metabolic parameters (glycaemia, insulinemia).
Measured: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Digestive hormones (GLP-1, ghrelin)
Measured: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Expired gases (H2, CH4)
Measured: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Resting metabolic rate.
Measured: Day 0 (at fasting before the standardized breakfast intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start7 Sep 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie FEUGIER-FAVIER, MD, Principal investigator, Centre de Recherche en Nutrition Humaine Rhone-Alpe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877548
- Sponsor's protocol ID
- 69HCL20_1032
- Acronym
- P2F-GR
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile
- ClinicalTrials.gov ID
- NCT04877548
- Acronym / sponsor ID
- P2F-GR / 69HCL20_1032
- Conditions
- Cardiometabolic Risk Factors, Obesity, Abdominal
- Keywords
- Postprandial glycaemia, Dietary fibers, Cardiometabolic risk, Fermented fruit flour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fermented orange flour | Experimental | Other: Fermented orange flourVolunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates |
| Fermented grape flour | Experimental | Other: Fermented grape flourVolunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates |
| Control | Placebo comparator | Other: ControlVolunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented orange flourVolunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates | Other | Fermented orange flour |
| Fermented grape flourVolunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates | Other | Fermented grape flour |
| ControlVolunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates | Other | Control |
Primary outcome
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.
Time frame: Through study completion, an average of 18 days
Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
14 secondary outcomes
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
Time frame: Through study completion, an average of 18 days
Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)
Time frame: 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)
Time frame: 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)
Time frame: Through study completion, 24 hours following the last day
Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis
Time frame: Through study completion, an average of 18 days
Satiety and digestive tolerance
Time frame: Through study completion, 24 hours following the last day
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Dietary intake
Time frame: Through study completion, an average of 18 days
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie FEUGIER-FAVIER, MD principal investigator
Centre de Recherche en Nutrition Humaine Rhone-Alpe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented orange flour and Fermented grape flour in people with Cardiometabolic Risk Factors and Obesity, Abdominal, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie FEUGIER-FAVIER, MD (4 78 86 19 72 ext. +33, nathalie.feugier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Through study completion, an average of 18 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.