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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00210-41 | Other Identifier | ID-RCB Number | |
| 295204 | Other Identifier | IRAS Project ID |
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| Name | Class |
|---|---|
| Biofortis, Merieux NutriSciences | INDUSTRY |
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The aim of this international, randomized, parallel arms, double-blind, placebo-controlled clinical trial is to investigate the safety and efficacy of a combination of the two Lactobacillus strains (NZ-GHMH-01) on glucose and insulin metabolism, in prediabetic subjects. This trial will include prediabetic (insulin resistant) subjects with excessive body weight (over-weight or obese, showing abdominal or visceral obesity) to be able to investigate the effect of the probiotic NZ-GHMH-01 on glycaemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NZ-GHMH-01 | Experimental | Dietary supplement in shape of capsule to be taken once per day in the evening. |
|
| Placebo | Placebo Comparator | The placebo is in shape of capsule to be taken once per day in the evening and in which only the active ingredients are not present. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NZ-GHMH-01 | Dietary Supplement | Each randomized subject will consume 1 capsule daily bringing 100 mg (≥ 2 x 109 CFU) of active ingredient during 16 weeks (from V2 to V5 visits). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin A1c (HbA1c) | Change from Baseline of HbA1c level between V2 and V5 visits (in %) between both groups. | V2 (randomization) and V5 (16 weeks of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin A1c (HbA1c) | Change from baseline of HbA1c level | V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Glucose kinetic parameters: ΔPeak and Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverses events | Incidence of adverses events | V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Heart Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Unit Biofortis | Saint-Herblain | Pays de la Loire Region | 44800 | France | ||
| Clinical Investigation Unit Paris |
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| Placebo | Dietary Supplement | Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits). |
|
Change from baseline of ΔPeak (g/L) and Cmax (g/L)
| V2 (randomization) and V5 (16 weeks of intervention) |
| Glucose kinetic parameters: T max | Change from baseline of T max (min) | V2 (randomization) and V5 (16 weeks of intervention) |
| Incremental Area Under the Curve (iAUC) of glucose | Change from baseline of the value of the iAUC of glucose, obtained during OGTT (iAUC0-120min) | V2 (randomization) and V5 (16 weeks of intervention) |
| Incremental Area Under the Curve (iAUC) of insulinemia | Change from baseline of the value of the iAUC of insulinemia, obtained during OGTT (iAUC0-120min) | V2 (randomization) and V5 (16 weeks of intervention) |
| Homeostasis Model of Assessment - insulin resistance (HOMA-IR) | Change from baseline of HOMA-IR index | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Quantitative Insulin sensitivity Check Index (QUICKI) | Change from baseline of QUICKI index | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Insulin Sensitivity Index (ISI) | Change from baseline of ISI index | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Fasting Plasma Glucose (FPG) | Change from baseline of FPG levels | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Fasting insulinemia | Change from baseline of fasting insulinemia levels | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Glycemia | Change from baseline of glycemia level | V2 (randomization) and V5 (16 weeks of intervention) |
| Glucagon Like Peptide 1 (GLP-1) | Change from baseline of GLP-1 level | V2 (randomization) and V5 (16 weeks of intervention) |
| Weight | Change from baseline of weight(in kg) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Body Mass Index (BMI) | Change from baseline of BMI (in kg/m2) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Waist and Hip | Change from baseline of Waist measurement (in cm) and Hip Circumference (in cm) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 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 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Liver function | Change from baseline of Aspartate Amino Transferase (ASAT), Alanine Amino Transferase (ALAT) and Gamma Glutamyl Transpeptidase (GGT) levels (expressed in ukat/L) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Total bilirubin | Change from baseline of Total bilirubin levels (expressed in umol/L) | V1 (screening) and V5 (16 weeks of intervention) |
| Triglycerides | fasting blood concentrations of triglycerides (expressed in g/L) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Lipid homeostasis | fasting blood concentrations of total cholesterol, High Density Lipoprotein cholesterol (HDLc), non-HDLc and Low Density Lipoprotein cholesterol (LDLc) (expressed in mmol/L) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| high-sensitivity C-reactive Protein (CRPhs) | Change from baseline of the CRPhs | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Cytokines | Change from baseline of the Cytokines IL-1alpha, IL-1beta, IL-6, IL-10, IL-12p70 and monocyte chemoattractant protein 1 (MCP1) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Tumor Necrosis Factors alpha (TNFα) | Change from baseline of the TNFα | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Overall health | Change from baseline of participant overall health (evaluated with SF36 questionnaire) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Blood metabolites | Change from baseline of Cholic acid, Chenodeoxycholic acid, Deoxycholic acid, Lithocholic acid, Ursodeoxy cholic acid, Taurocholic acid and Glycochenodeoxycholic acids | V2 (randomization) and V5 (16 weeks of intervention) |
| Gastrointestinal Symptoms | Change from baseline of gastrointestinal symptoms (evaluated with Gastrointestinal Symptom Rating Scale) | V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
overall health through hemodynamic parameters: Heart Rate (expressed in bpm)
| V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Blood pressure | overall health through hemodynamic parameters: Systolic Blood Pressure and Diastolic Blood Pressure (expressed in mmHg) | V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Complete Blood Count (CBC) | overall health through CBC: Leukocytes, Red blood cells, Hemoglobin, Hematocrit, Poly. Neutrophils, Poly. Neutrophils, Poly. Eosinophils, Poly. Eosinophils, Poly. Basophils, Poly. Basophils, Lymphocytes, Lymphocytes, Monocytes, Monocytes, Platelets (expressed in Giga/L and %) | V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention) |
| Fecal zonulin | Change from baseline of fecal zonulin level | V2 (randomization) and V5 (16 weeks of intervention) |
| Fecal calprotectin | Change from baseline of fecal calprotectin level | V2 (randomization) and V5 (16 weeks of intervention) |
| Paris |
| 75012 |
| France |
| Neomed Brasov | Brasov | Romania |
| Fundatia Ana Aslan International | Bucharest | 030167 | Romania |
| Military Hospital- Spitalul Militar Central Dr "Carol Davila" | Bucharest | Romania |
| Parhon Institute- Institutul National de Endocrinologie C.I. Parhon | Bucharest | Romania |
| Suceava County Hospital - Spitalul Județean de Urgență "Sfântul Ioan cel Nou" | Suceava | 720224 | Romania |
| CPS Research | Glasgow | G20 0XA | United Kingdom |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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