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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02304-35 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Food ingredient containing non digestible carbohydrates, in shape of powder |
|
| Placebo | Placebo Comparator | Food ingredient containing containing 95% of maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non digestible carbohydrates | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | Change from baseline of Hba1c level (%) | V2 (randomization) and V5 (12 weeks of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | Absolute variations of Hba1c level (%) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Number of adverse events (including gastro-intestinal symptoms) by subject that appeared during the entire duration of the study | V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention) |
| Heart Rate (HR) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPL | Lille | France | ||||
| Biofortis Center Paris |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41479657 | Derived | 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. |
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multicentre randomized, parallel arms, double-blind, placebo-controlled clinical trial
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| Placebo | Dietary 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. |
|
| 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) | 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) | 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 | 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) | V2 (randomization) and V5 (12 weeks of intervention) |
| Glycemia level | Change from baseline of glycemia level (g/L) | 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) | V2 (randomization) and V5 (12 weeks of intervention) |
| Insulinemia | Change from baseline of insulinemia levels (mU/L) | 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) | V2 (randomization) and V5 (12 weeks of intervention) |
| Glucacon-like Peptide 1 (GLP-1) | Change from baseline of GLP-1 levels (pmol/L) | V2 (randomization) and V5 (12 weeks of intervention) |
| Bone mineral composition | Change from baseline of bone mineral composition (kg) | V2 (randomization) and V5 (12 weeks of intervention) |
| Total lean mass | Change from baseline of total lean mass (g and %) | V2 (randomization) and V5 (12 weeks of intervention) |
| Total fat mass | Change from baseline of total fat mass (g and %) | V2 (randomization) and V5 (12 weeks of intervention) |
| Bone Mineral Density | Change from baseline of bone mineral density (g/cm2) | V2 (randomization) and V5 (12 weeks of intervention) |
| Total Body Mass | Change from baseline of total body mass (kg) | V2 (randomization) and V5 (12 weeks of intervention) |
| Weight | Change from baseline of weight (in kg) | 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) | 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) | 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 | 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 | V2 (randomization) and V5 (12 weeks of intervention) |
| Total energy intake | Change from baseline of total energy intake - TEI (kcal/day) | 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) | 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) | 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) | 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) | 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) | 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) | V2 (randomization) and V5 (12 weeks of intervention) |
Change from baseline of HR (bpm) |
| V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention) |
| Blood pressure | Change from baseline of Systolic Blood Pressure and Diastolic Blood Pressure (mmHg) | V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention) |
| Paris |
| 75012 |
| France |
| UIC BIOFORTIS Saint-Herblain | Saint-Herblain | France |
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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