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 (NOVOGLUCOSE)

Novozymes

Status

Completed

Conditions

Prediabetic State

Dysglycemia

Treatments

Dietary Supplement: NZ-GHMH-01

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04767789

2021-A00210-41 (Other Identifier)

PEC20022

295204 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged between 18 and 75 years (limits included)
Having BMI between 18,5 and 40 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 (more than 5 cigarettes per day)
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 except fibers, omega 3 and vitamins (other than Vitamin D3) if the subject agrees to keep his/her intake unchanged throughout the study;
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
Abuse of alcohol, defined as more than 21 alcohol units per week for men and 14 units for women, or unwillingness to refrain from alcohol intake the day before V2 and V5 visits
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