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

NCT ID: NCT04767789

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2022-11-29

Brief Summary

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.

Conditions

Prediabetic State; Dysglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NZ-GHMH-01

Dietary supplement in shape of capsule to be taken once per day in the evening.

Group Type: EXPERIMENTAL

NZ-GHMH-01

Intervention Type: 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).

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biofortis, Merieux NutriSciences

INDUSTRY

Sponsor Role: collaborator

Novozymes A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Investigation Unit Biofortis

Saint-Herblain, Pays de la Loire Region, France

Clinical Investigation Unit Paris

Paris, , France

Neomed Brasov

Brasov, , Romania

Fundatia Ana Aslan International

Bucharest, , 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, , Romania

CPS Research

Glasgow, , United Kingdom

Countries

France; Romania; United Kingdom

Other Identifiers

2021-A00210-41

Identifier Type: OTHER

Identifier Source: secondary_id

295204

Identifier Type: OTHER

Identifier Source: secondary_id

PEC20022

Identifier Type: -

Identifier Source: org_study_id