Pre DiabetesFOS_GLUCOSENCT04767672
Study to Assess the Effects of Non Digestible Carbohydrates on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects
A study testing Non digestible carbohydrates in people with Pre Diabetes and Prediabetic State, run by Tereos at 3 sites in France.
Trial summary
This clinical study aims to prove that the efficacy of non digestible carbohydrates supplementation (daily dose of 20 grams consumed twice a day for 12 weeks) on the regulation of glucose homeostasis is superior than placebo in prediabetic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pre Diabetes, Prediabetic State, Dysglycemia
- What is being tested?
- Non digestible carbohydrates
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesFrance
- Study dates
- 5 May 2021to Mar 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years (limits included);
- BMI between 23 and 34.9 kg/m² (limits included);
- Dysglycemic or prediabetic subjects with no antidiabetic medication (medical or lifestyle (hygiene-dietetic measures or specific regimen treatment);
- Consuming 10 to 20 g quantity of fiber per day (based on the 3-days food diary fulfilled by the subject between V1 and V2 visits);
- Smoking maximum 10 cigarettes per week or equivalent and agreeing to keep this habit unchanged throughout the study;
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
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- Affiliated with a social security scheme;
- Agree to be registered on the volunteers in biomedical research file;
- Fasting venous glycemia ≥ 1 g/L and ≤ 1.25 g/L at V1 visit.
Who cannot join
- Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder;
- Severe chronic disease or Intestinal Bowel Syndrome (IBS) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator;
- History of retinopathy, microalbuminuria, ischemic cardiovascular event in the 6 months before the study;
- Known or a suspected food allergy or intolerance orhypersensitivity to any food ingredient;
- Known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient;
- Pregnant or lactating women or intending to become pregnant within 4 months ahead;
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- Women starting hormone replacement therapy or oral contraception (treatment must be stable for at least 3 months);
- History of bariatric surgery;
- History of any surgery in the 3 months before V1 visit or having scheduled any surgery within 4 months ahead;
- Under dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit (< 3 months);
- Under treatment which could significantly affect parameter(s) followed during the study according to the investigator or stopped less than 3 months before the V1 visit;
- Under antibiotic treatment in the 3 to 6 months before V1 visit, depending on the antibiotic consumed and according to the investigator;
- Significant change in food habits or in physical activity in the 3 months before V1 visit or not agreeing to keep them unchanged throughout the study;
- Current or planned in the next 4 months specific diet (hyper or hypocaloric, vegan, vegetarian…) or stopped less than 3 months before the study;
- Personal history of anorexia nervosa, bulimia or significant eatingdisorders according to the investigator;
- Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study;
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros;
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- Psychological or linguistic incapability to sign the informed consent;
- Impossible to contact in case of emergency.
- Fasting blood triglycerides > 3,5 g/L;
- Fasting blood of total cholesterol > 4,5 g/L or HDLc < 0,1 g/L with an abnormality judged as clinically significant according to the investigator;
- Blood ASAT, ALAT or GGT > 3 times ULN (laboratory Upper Limit of Normal);
- Blood urea > 12 mmol/L or creatinine > 125 μmol/L;
- Complete Blood Count (CBC) with hemoglobin < 11 g/L or leucocytes < 3000/mm3 or leucocytes > 16000/mm3.
Trial locations and contacts
3 sites in 1 country.
France3 sites
IPL
Lille
Biofortis Center Paris
Paris, 75012
UIC BIOFORTIS Saint-Herblain
Saint-Herblain
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Effects of Short-Chain Fructo-Oligosaccharides on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects
This clinical study aims to prove that the efficacy of non digestible carbohydrates supplementation (daily dose of 20 grams consumed twice a day for 12 weeks) on the regulation of glucose homeostasis is superior than placebo in prediabetic subjects.
- Conditions
- Pre Diabetes, Prediabetic State, Dysglycemia, PreDiabetes
- Being tested
- Non digestible carbohydrates, Placebo
- Medical subject headings
- Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non digestible carbohydratesDietary supplement
the subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks.
PlaceboDietary supplement
the subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Food ingredient containing non digestible carbohydrates, in shape of powder Receives: Dietary Supplement: Non digestible carbohydrates |
| Placebo | Placebo comparator | Food ingredient containing containing 95% of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Change from baseline of Hba1c level (%)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Secondary outcomes (28)
Glycated hemoglobin
Absolute variations of Hba1c level (%)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fasting glycemia
Change from baseline of fasting glycemia (g/L)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fasting insulinemia
Change from baseline of fasting insulinemia (mU/L)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fructosamine
Change from baseline of fructosamine (μmol/L)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Insulin indexes
Change from baseline of HOMA-IR (Homeostasis Model Assessment of Insulin) and QUICKI (Quantitative Insulin sensitivity Check Index) indices
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Insulin sensitivity index
Change from baseline of insulin sensitivity index (ISI)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Glycemia level
Change from baseline of glycemia level (g/L)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Incremental Area Under the Curve (iAUC) of glycemia
Change from baseline of iAUC of glycemia (g/L)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Insulinemia
Change from baseline of insulinemia levels (mU/L)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Incremental Area Under the Curve (iAUC) of insulinemia
Change from baseline of iAUC of insulinemia (mU/L)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Glucacon-like Peptide 1 (GLP-1)
Change from baseline of GLP-1 levels (pmol/L)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Bone mineral composition
Change from baseline of bone mineral composition (kg)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Total lean mass
Change from baseline of total lean mass (g and %)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Total fat mass
Change from baseline of total fat mass (g and %)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Bone Mineral Density
Change from baseline of bone mineral density (g/cm2)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Total Body Mass
Change from baseline of total body mass (kg)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Weight
Change from baseline of weight (in kg)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Body Mass Index (BMI)
Change from baseline of BMI (in kg/m2)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Waist and Hip measurement
Change from baseline of waist and hip Circumference (in cm)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Anthropometric ratios
Change from baseline of Waist to Hip ratio and Waist to Height ratio
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Satiety and Appetite sensation
Change on satiety and appetite sensation using 100-mm VAS to complete 15 min before the meal, 30 min, 60 min, 120 min, 180 min and 240 min after the meal at which study product was consumed
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Total energy intake
Change from baseline of total energy intake - TEI (kcal/day)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Energy intake
Change from baseline of percentage of energy intake from fat, carbohydrates and protein (g and %TEI)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fiber intake
Change from baseline of percentage of percentage of fiber (g)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Alcohol intake
Change from baseline of percentage of percentage of alcohol intake (absolute quantities, g/day)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Biomarker of inflammation
Change from baseline of high-sensitivity C-reactive Protein (CRPhs) (mg/L)
Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Intestinal microbiota composition
Change from baseline microbiota composition for alpha-diversity indices (Shannon and Chao indices) and abundances at the phylum, family and genus level assessed by 16S metabarcoding (in a subgroup of 30 subjects only)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Fecal Short-Chain Fatty Acids (SCFA)
Change from baseline of fermentative activity of the intestinal microbiota assessed by measuring short-chain fatty acids concentrations in stool (in the same subgroup of 30 subjects only)
Measured: V2 (randomization) and V5 (12 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start5 May 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre randomized, parallel arms, double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tereos
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Principal investigator, Isabelle Metreau, Tereos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767672
- Sponsor's protocol ID
- PEC19095
- Other IDs
- 2020-A02304-35
- Acronym
- FOS_GLUCOSE
- Status last verified
- Dec 2023
- First submitted
- 19 Feb 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Bourgot C, Capronnier O, Graf S, Carton T. Targeting gut microbiota with short-chain fructo-oligosaccharides prebiotic fibers to support metabolic health in overweight prediabetic adults: a randomized, double-blinded, placebo-controlled study. Front Nutr. 2025 Dec 17;12:1718169. doi: 10.3389/fnut.2025.1718169. eCollection 2025.
PubMed 41479657
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Effects of Short-Chain Fructo-Oligosaccharides on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects
- ClinicalTrials.gov ID
- NCT04767672
- Acronym / sponsor ID
- FOS_GLUCOSE / PEC19095
- Conditions
- Pre Diabetes, Prediabetic State, Dysglycemia, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- TereosIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 5 May 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 23 Feb 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.
This clinical study aims to prove that the efficacy of non digestible carbohydrates supplementation (daily dose of 20 grams consumed twice a day for 12 weeks) on the regulation of glucose homeostasis is superior than placebo in prediabetic subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicentre randomized, parallel arms, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Dietary Supplement: Non digestible carbohydratesFood ingredient containing non digestible carbohydrates, in shape of powder |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFood ingredient containing containing 95% of maltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years (limits included);
- BMI between 23 and 34.9 kg/m² (limits included);
- Dysglycemic or prediabetic subjects with no antidiabetic medication (medical or lifestyle (hygiene-dietetic measures or specific regimen treatment);
- Consuming 10 to 20 g quantity of fiber per day (based on the 3-days food diary fulfilled by the subject between V1 and V2 visits);
- Smoking maximum 10 cigarettes per week or equivalent and agreeing to keep this habit unchanged throughout the study;
Key exclusion criteria (26 listed)
- Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder;
- Severe chronic disease or Intestinal Bowel Syndrome (IBS) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator;
- History of retinopathy, microalbuminuria, ischemic cardiovascular event in the 6 months before the study;
- Known or a suspected food allergy or intolerance orhypersensitivity to any food ingredient;
- Known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient;
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 |
|---|---|---|
| Non digestible carbohydratesthe subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks. | Dietary supplement | Test product |
| Placebothe subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Glycated hemoglobin
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Change from baseline of Hba1c level (%)
28 secondary outcomes
Glycated hemoglobin
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fasting glycemia
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fasting insulinemia
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fructosamine
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Insulin indexes
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Insulin sensitivity index
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Glycemia level
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Incremental Area Under the Curve (iAUC) of glycemia
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Insulinemia
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Incremental Area Under the Curve (iAUC) of insulinemia
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Glucacon-like Peptide 1 (GLP-1)
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Bone mineral composition
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Total lean mass
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Total fat mass
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Bone Mineral Density
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Total Body Mass
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Weight
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Body Mass Index (BMI)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Waist and Hip measurement
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Anthropometric ratios
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Satiety and Appetite sensation
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Total energy intake
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Energy intake
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fiber intake
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Alcohol intake
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Biomarker of inflammation
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Intestinal microbiota composition
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Fecal Short-Chain Fatty Acids (SCFA)
Time frame: V2 (randomization) and V5 (12 weeks of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 41479657Le Bourgot C, Capronnier O, Graf S, Carton T. Targeting gut microbiota with short-chain fructo-oligosaccharides prebiotic fibers to support metabolic health in overweight prediabetic adults: a randomized, double-blinded, placebo-controlled study. Front Nutr. 2025 Dec 17;12:1718169. doi: 10.3389/fnut.2025.1718169. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non digestible carbohydrates in people with Pre Diabetes and Prediabetic State, run by Tereos at 3 sites 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 9 inclusion and 26 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: V2 (randomization) and V5 (12 weeks of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767672, which also lists 1 linked publication.
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 3 Jan 2024.