NZ-GHMH-01
Dietary SupplementEach 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).
NCT Number: NCT04767789
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Clinical Investigation Unit Biofortis, Saint-Herblain, Pays de la Loire Region, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from Baseline of HbA1c level between V2 and V5 visits (in %) between both groups.
Time frame: V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of HbA1c level
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of ΔPeak (g/L) and Cmax (g/L)
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of T max (min)
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of the value of the iAUC of glucose, obtained during OGTT (iAUC0-120min)
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of the value of the iAUC of insulinemia, obtained during OGTT (iAUC0-120min)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of HOMA-IR index
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of QUICKI index
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of ISI index
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of FPG levels
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of fasting insulinemia levels
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of glycemia level
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of GLP-1 level
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of weight(in kg)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of BMI (in kg/m2)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of Waist measurement (in cm) and Hip Circumference (in cm)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of Waist to Hip ratio and Waist to Height ratio
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of Aspartate Amino Transferase (ASAT), Alanine Amino Transferase (ALAT) and Gamma Glutamyl Transpeptidase (GGT) levels (expressed in ukat/L)
Time frame: V1 (screening) and V5 (16 weeks of intervention)
Change from baseline of Total bilirubin levels (expressed in umol/L)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
fasting blood concentrations of triglycerides (expressed in g/L)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
fasting blood concentrations of total cholesterol, High Density Lipoprotein cholesterol (HDLc), non-HDLc and Low Density Lipoprotein cholesterol (LDLc) (expressed in mmol/L)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of the CRPhs
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of the Cytokines IL-1alpha, IL-1beta, IL-6, IL-10, IL-12p70 and monocyte chemoattractant protein 1 (MCP1)
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of the TNFα
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of participant overall health (evaluated with SF36 questionnaire)
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of Cholic acid, Chenodeoxycholic acid, Deoxycholic acid, Lithocholic acid, Ursodeoxy cholic acid, Taurocholic acid and Glycochenodeoxycholic acids
Time frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Change from baseline of gastrointestinal symptoms (evaluated with Gastrointestinal Symptom Rating Scale)
Time frame: V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
Incidence of adverses events
Time frame: V1 (Inclusion), 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)
Time frame: V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
overall health through hemodynamic parameters: Systolic Blood Pressure and Diastolic Blood Pressure (expressed in mmHg)
Time frame: V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
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 %)
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of fecal zonulin level
Time frame: V2 (randomization) and V5 (16 weeks of intervention)
Change from baseline of fecal calprotectin level
Novozymes A/S
Industry
Double-blind, Placebo-controlled, Randomized Pilot Clinical Trial to Evaluate the Efficacy and Safety of the Probiotic Strains Limosilactocillus Reuteri DSM 32910 and Lacticaseibacillus Paracasei DSM 32851 on Glucose Homeostatis in Prediabetic Adults
Acronym: NOVOGLUCOSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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