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Prediabetic StateNOVOGLUCOSENCT04767789

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

A study testing NZ-GHMH-01 in people with Prediabetic State and Dysglycemia, run by Novozymes A/S at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Prediabetic State, Dysglycemia
What is being tested?
NZ-GHMH-01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
8 sitesin 3 countries
Study dates
12 May 2021to 29 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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%

Who cannot join

  • 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
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  • 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

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Romania5 sites

  • Neomed Brasov

    Brasov

  • Fundatia Ana Aslan International

    Bucharest, 030167

  • Military Hospital- Spitalul Militar Central Dr "Carol Davila"

    Bucharest

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

    Bucharest

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

    Suceava, 720224

Other trials in Romania

France2 sites

  • Clinical Investigation Unit Paris

    Paris, 75012

  • Clinical Investigation Unit Biofortis

    Saint-Herblain, Pays de la Loire Region, 44800

Other trials in France

United Kingdom1 site

  • CPS Research

    Glasgow, G20 0XA

Other trials in United Kingdom

About this study

Official title: 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

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.

Being tested
NZ-GHMH-01, Placebo
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NZ-GHMH-01Dietary 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).

  • PlaceboDietary supplement

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

Study groups in NCT04767789
Study groupRoleWhat they receive
NZ-GHMH-01ExperimentalDietary supplement in shape of capsule to be taken once per day in the evening.
Receives: Dietary Supplement: NZ-GHMH-01
PlaceboPlacebo comparatorThe 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated Hemoglobin A1c (HbA1c)

    Change from Baseline of HbA1c level between V2 and V5 visits (in %) between both groups.

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

Secondary outcomes (26)

  1. Glycated Hemoglobin A1c (HbA1c)

    Change from baseline of HbA1c level

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

  2. Glucose kinetic parameters: ΔPeak and Cmax

    Change from baseline of ΔPeak (g/L) and Cmax (g/L)

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

  3. Glucose kinetic parameters: T max

    Change from baseline of T max (min)

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

  4. Incremental Area Under the Curve (iAUC) of glucose

    Change from baseline of the value of the iAUC of glucose, obtained during OGTT (iAUC0-120min)

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

  5. Incremental Area Under the Curve (iAUC) of insulinemia

    Change from baseline of the value of the iAUC of insulinemia, obtained during OGTT (iAUC0-120min)

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

  6. Homeostasis Model of Assessment - insulin resistance (HOMA-IR)

    Change from baseline of HOMA-IR index

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  7. Quantitative Insulin sensitivity Check Index (QUICKI)

    Change from baseline of QUICKI index

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  8. Insulin Sensitivity Index (ISI)

    Change from baseline of ISI index

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  9. Fasting Plasma Glucose (FPG)

    Change from baseline of FPG levels

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  10. Fasting insulinemia

    Change from baseline of fasting insulinemia levels

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  11. Glycemia

    Change from baseline of glycemia level

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

  12. Glucagon Like Peptide 1 (GLP-1)

    Change from baseline of GLP-1 level

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

  13. Weight

    Change from baseline of weight(in kg)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  14. Body Mass Index (BMI)

    Change from baseline of BMI (in kg/m2)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  15. Waist and Hip

    Change from baseline of Waist measurement (in cm) and Hip Circumference (in cm)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  16. Anthropometric ratios

    Change from baseline of Waist to Hip ratio and Waist to Height ratio

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  17. Liver function

    Change from baseline of Aspartate Amino Transferase (ASAT), Alanine Amino Transferase (ALAT) and Gamma Glutamyl Transpeptidase (GGT) levels (expressed in ukat/L)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  18. Total bilirubin

    Change from baseline of Total bilirubin levels (expressed in umol/L)

    Measured: V1 (screening) and V5 (16 weeks of intervention)

  19. Triglycerides

    fasting blood concentrations of triglycerides (expressed in g/L)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  20. Lipid homeostasis

    fasting blood concentrations of total cholesterol, High Density Lipoprotein cholesterol (HDLc), non-HDLc and Low Density Lipoprotein cholesterol (LDLc) (expressed in mmol/L)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  21. high-sensitivity C-reactive Protein (CRPhs)

    Change from baseline of the CRPhs

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  22. Cytokines

    Change from baseline of the Cytokines IL-1alpha, IL-1beta, IL-6, IL-10, IL-12p70 and monocyte chemoattractant protein 1 (MCP1)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  23. Tumor Necrosis Factors alpha (TNFα)

    Change from baseline of the TNFα

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  24. Overall health

    Change from baseline of participant overall health (evaluated with SF36 questionnaire)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

  25. Blood metabolites

    Change from baseline of Cholic acid, Chenodeoxycholic acid, Deoxycholic acid, Lithocholic acid, Ursodeoxy cholic acid, Taurocholic acid and Glycochenodeoxycholic acids

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

  26. Gastrointestinal Symptoms

    Change from baseline of gastrointestinal symptoms (evaluated with Gastrointestinal Symptom Rating Scale)

    Measured: V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start12 May 2021
  3. Primary completion29 Nov 2022
  4. Study completion29 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04767789
Sponsor's protocol ID
PEC20022
Other IDs
2021-A00210-41, 295204
Acronym
NOVOGLUCOSE
Status last verified
Jun 2023
First submitted
4 Feb 2021
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NZ-GHMH-01 in people with Prediabetic State and Dysglycemia, run by Novozymes A/S at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Romania, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated Hemoglobin A1c (HbA1c) (time frame: V2 (randomization) and V5 (16 weeks of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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