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

NCT04767789 | Completed

• 3 other identifiers: PEC200222021-A00210-41295204
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (26)

• Glycated Hemoglobin A1c (HbA1c)

  V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

• Glucose kinetic parameters: ΔPeak and Cmax

  V2 (randomization) and V5 (16 weeks of intervention)

• Glucose kinetic parameters: T max

  V2 (randomization) and V5 (16 weeks of intervention)

• Incremental Area Under the Curve (iAUC) of glucose

  V2 (randomization) and V5 (16 weeks of intervention)

• Incremental Area Under the Curve (iAUC) of insulinemia

  V2 (randomization) and V5 (16 weeks of intervention)

Other Outcomes (6)

• 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

  V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

• Blood pressure

  V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

Study Arms (2)

NZ-GHMH-01

EXPERIMENTAL

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

Dietary Supplement: NZ-GHMH-01

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.

Dietary Supplement: Placebo

Interventions

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).

NZ-GHMH-01

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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 personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator

Sponsors & Collaborators

• Novozymes A/S: lead
• Biofortis, Merieux NutriSciences: collaborator

Study Sites (8)

Clinical Investigation Unit Biofortis

Saint-Herblain, Pays de la Loire Region, 44800, France

Location

Clinical Investigation Unit Paris

Paris, 75012, France

Location

Neomed Brasov

Brasov, Romania

Location

Fundatia Ana Aslan International

Bucharest, 030167, Romania

Location

Military Hospital- Spitalul Militar Central Dr "Carol Davila"

Bucharest, Romania

Location

Parhon Institute- Institutul National de Endocrinologie C.I. Parhon

Bucharest, Romania

Location

Suceava County Hospital - Spitalul Județean de Urgență "Sfântul Ioan cel Nou"

Suceava, 720224, Romania

Location

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 23, 2021
• Study Start: May 12, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); RO (5); GB (1)