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

Overview

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.

Full Title of Study: “Double-blind, Placebo-controlled, Randomized 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2021

Interventions

  • Dietary Supplement: NZ-GHMH-01
    • 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).
  • Dietary Supplement: Placebo
    • Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).

Arms, Groups and Cohorts

  • Experimental: NZ-GHMH-01
    • Dietary supplement in shape of capsule to be taken once per day in the evening.
  • Placebo Comparator: Placebo
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Glycated Hemoglobin A1c (HbA1c)
    • 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.

Secondary Measures

  • Glycated Hemoglobin A1c (HbA1c)
    • Time Frame: V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
    • Change from baseline of HbA1c level
  • Glucose kinetic parameters: ΔPeak and Cmax
    • Time Frame: V2 (randomization) and V5 (16 weeks of intervention)
    • Change from baseline of ΔPeak (g/L) and Cmax (g/L)
  • Glucose kinetic parameters: T max
    • Time Frame: V2 (randomization) and V5 (16 weeks of intervention)
    • Change from baseline of T max (min)
  • Incremental Area Under the Curve (iAUC) of glucose
    • 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)
  • Incremental Area Under the Curve (iAUC) of insulinemia
    • 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)
  • Homeostasis Model of Assessment – insulin resistance (HOMA-IR)
    • 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
  • Quantitative Insulin sensitivity Check Index (QUICKI)
    • 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
  • Insulin Sensitivity Index (ISI)
    • 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
  • Fasting Plasma Glucose (FPG)
    • 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
  • Fasting insulinemia
    • 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
  • Glycemia
    • Time Frame: V2 (randomization) and V5 (16 weeks of intervention)
    • Change from baseline of glycemia level
  • Glucagon Like Peptide 1 (GLP-1)
    • Time Frame: V2 (randomization) and V5 (16 weeks of intervention)
    • Change from baseline of GLP-1 level
  • Weight
    • 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)
  • Body Mass Index (BMI)
    • 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)
  • Waist and Hip
    • 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)
  • Anthropometric ratios
    • 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
  • Liver function
    • 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)
  • Total bilirubin
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)
    • Change from baseline of Total bilirubin levels (expressed in umol/L)
  • Triglycerides
    • 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)
  • Lipid homeostasis
    • 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)
  • high-sensitivity C-reactive Protein (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 CRPhs
  • Cytokines
    • 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)
  • Tumor Necrosis Factors alpha (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 the TNFα
  • Overall health
    • 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)
  • Blood metabolites
    • 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
  • Gastrointestinal Symptoms
    • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • Aged between 18 and 75 years (limits included) – Having BMI between 25 and 34.9 kg/m² (limits included) – Prediabetic – For women: Non menopausal with the same reliable contraception or menopausal without or with hormone replacement therapy – Agreeing to keep his lifestyle habits unchanged throughout the study – With stable weight within ± 5% in the last three months – Having a good general and mental health with in the opinion of the investigator – Having signed informed consent form – Affiliated with a social security scheme (for French sites only) – Agreed to be registered on the subjects in the "VRB" (biomedical research file (for French sites only)) – Having HbA1c level ≥ 5.7% and ≤ 6.4% Exclusion Criteria:

  • Metabolic disorder such as diabetes or uncontrolled thyroidal trouble or other metabolic disorder; – Having a history of medication for diabetes and dyslipidemia – Uncontrolled hypertension – Severe chronic disease or gastrointestinal disorders – Having done the second injection of COVID-19 vaccination or between the first and the second injection within the last 2 weeks prior to V1 visit – Food allergy or intolerance or hypersensitivity to any of the study products' ingredient – Pregnant or lactating women or intending to become pregnant within 3 months ahead – Smoking subject – Having a history of bariatric surgery – Having a history of any surgery in the 3 months before V1 visit or having scheduled any surgery within 6 months ahead – Under dietary supplement which could significantly affect parameter(s) followed during the study or stopped in a too short period before the V1 visit (< 6 weeks); – Under treatment which could significantly affect parameter(s) followed during the study – Under antibiotic treatment in the 3 to 6 months before V1 visit – With 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 – With a current or planned in the next 5 months specific diet (hyper or hypocaloric, vegan…) or putted in place since less than 3 months before the inclusion visit – With a personal history of anorexia nervosa, bulimia or significant eating disorders 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 – Having a lifestyle deemed incompatible with the study according to the investigator – Taking part in another clinical trial or having taken part in another clinical trial in the 3 months before the inclusion visit; – Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros (for French sites only); – Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; – Presenting a psychological or linguistic incapability to sign the informed consent; – Impossible to contact in case of emergency. – Having blood ASAT, ALAT or GGT levels out of range and clinically significant according to the investigator – Having CBC with hemoglobin < 11 g/L or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novozymes A/S
  • Collaborator
    • Biofortis, Merieux NutriSciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • N’deye SECK, 0240205799, ndeye.seck@mxns.com

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