Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes Mellitus in Greece

NCT06032988 | Completed

• 1 other identifier: IRB approval No 306/26.04.2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a matching placebo capsule that does not contain active ingredients). The main questions to answer are:

1. 1.Will glycemic indices, i.e., glycated hemoglobin (HbA1c) and fasting blood glucose, be different in people taking the probiotic treatment, compared to those not taking it, after 6 months?
2. 2.Will other metabolic indices, mostly blood lipid levels (total cholesterol, triglycerides, HDL- and LDL-cholesterol) and liver function tests, be different in people taking the probiotic treatment compared to those not taking it after 6 months?
3. 3.Will adiposity measures (weight, waist circumference) be affected by probiotic treatment in the two groups? Studies in animals and humans, mostly of shorter duration (\<12 weeks) so far, have shown a possible trend towards improvement with probiotic treatment in all these parameters, but longer-term studies are scarce, and in Greece, there is none. Since diabetes treatment is complex (usually involving many medications) and expensive, developing cost-effective functional healthcare products for regulating blood glucose more efficiently has been recognized as a beneficial alternative.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus type 2; Probiotics; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Effects of probiotics supplementation on glycemic control (HbA1c)

  To measure the difference of the change from baseline in mean HbA1c (percentage points) between the intervention (probiotic) group and placebo, after 6 months

  6 months

Secondary Outcomes (5)

• Effects of probiotics supplementation on fasting blood glucose (FBG)

  6 months

• Effects of probiotics supplementation on lipid parameters (Total cholesterol, Triglycerides, HDL-C, LDL-C)

  6 months

• Effects of probiotics supplementation on liver function tests (AST, ALT, γGT, Alkaline Phosphatase)

  6 months

• Effects of probiotics supplementation on adiposity measures (BMI, Waist circumference)

  6 months

• Effects of probiotics supplementation on changes in gut microbiota diversity (alpha- and beta-diversity)

  6 months

Study Arms (2)

LactoLevure

ACTIVE COMPARATOR

The probiotic capsule LactoLevure\^R will be given once a day

Dietary Supplement: LactoLevure

Placebo

PLACEBO COMPARATOR

Placebo capsules will consist of identical to the LactoLevure\^R capsules of powdered glucose polymer, and will be given once a day

Dietary Supplement: LactoLevure

Interventions

LactoLevure DIETARY_SUPPLEMENT

Participants will receive LactoLevure\^R probiotic dietary supplement or matching placebo once a day.

Also known as: Probiotic

LactoLevure; Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2D diagnosis of \>6 months' duration
• Age 18-90 years
• A body-mass index (BMI) \>18.5 kg/m\^2
• HbA1c level \>6 percent (%)
• on stable antidiabetic medications (oral or injectable glucagon-like peptide 1 receptor agonists \[GLP-1 RAs\]) for 8 weeks before the screening

You may not qualify if:

• Type 1 or other type of diabetes
• Pregnancy or wishing to become pregnant during the study
• End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases \>3.5x above normal)
• The use of other probiotic products or antibiotics over the previous 6 months
• Participation in other clinical trials
• Insulin administration
• The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)

Sponsors & Collaborators

• Konstantinos Makrilakis, MD: lead
• Uni-Pharma: collaborator

Study Sites (1)

Laiko General Hospital

Athens, Attica, 11526, Greece

Location

Related Publications (3)

• Bock PM, Telo GH, Ramalho R, Sbaraini M, Leivas G, Martins AF, Schaan BD. The effect of probiotics, prebiotics or synbiotics on metabolic outcomes in individuals with diabetes: a systematic review and meta-analysis. Diabetologia. 2021 Jan;64(1):26-41. doi: 10.1007/s00125-020-05295-1. Epub 2020 Oct 13.

  PMID: 33047170 BACKGROUND

• Rittiphairoj T, Pongpirul K, Janchot K, Mueller NT, Li T. Probiotics Contribute to Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Jun 1;12(3):722-734. doi: 10.1093/advances/nmaa133.

  PMID: 33126241 BACKGROUND

• Vallianou NG, Stratigou T, Tsagarakis S. Microbiome and diabetes: Where are we now? Diabetes Res Clin Pract. 2018 Dec;146:111-118. doi: 10.1016/j.diabres.2018.10.008. Epub 2018 Oct 18.

  PMID: 30342053 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• KONSTANTINOS MAKRILAKIS, MD, PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned (using a computer generator \[www.randomization.com\], which randomizes each subject to a single treatment using randomly permuted blocks) to receive probiotic or placebo treatment, blinded to participants, study investigators, and physicians caring for the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: The present study will be a single-center, randomized, double-blind, placebo-controlled trial of a 6-month duration involving persons with T2D. Participants will receive either a multi-strain probiotic supplement (in the form of a capsule) or a matching placebo capsule once a day.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 13, 2023
• Study Start: August 23, 2023
• Primary Completion: September 2, 2023
• Study Completion: September 2, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within six months of completion of the study
• Access Criteria: Anyone who wishes to access the data

Locations

GR (1)