The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study

NCT ID: NCT06092060

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-07-20

Brief Summary

The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy.

The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects.

Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

the group GS

probiotic treatment group, ca. 20 participants

Group Type: EXPERIMENTAL

the group GS (probiotic)

Intervention Type: DIETARY_SUPPLEMENT

The probiotic-supplemented group will receive 2 capsules of freeze-dried powder of a probiotic mixture containing the following bacterial strains twice a day, 3-month: Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24

the group GP

placebo group, ca. 20 participants

Group Type: PLACEBO_COMPARATOR

the group GP (placebo)

Intervention Type: DIETARY_SUPPLEMENT

The placebo group will receive 2 capsules consisting of the probiotic product carrier, which is corn starch and maltodextrin, twice a day, 3-month.

Interventions

the group GS (probiotic)

The probiotic-supplemented group will receive 2 capsules of freeze-dried powder of a probiotic mixture containing the following bacterial strains twice a day, 3-month: Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24

Intervention Type: DIETARY_SUPPLEMENT

the group GP (placebo)

The placebo group will receive 2 capsules consisting of the probiotic product carrier, which is corn starch and maltodextrin, twice a day, 3-month.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• women 25-45 years old, menstruating, BMI 25-32.9 kg / m2, insulin resistance based on the HOMA-IR index (cut-off point 2.5

Exclusion Criteria

• type 1 and 2 diabetes,
• poorly controlled arterial hypertension (mean SBP values> 140mmHg and / or mean DBP values> 90mmHg) within the last month and / or the need to modify pharmacological treatment,
• 2nd degree obesity, BMI> 35 kg / m2,
• lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation,
• positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis,
• features of heart failure on physical examination and / or additional examinations (chest X-ray, echocardiography),
• clinically significant arrhythmias or conduction disturbances,
• chronic kidney disease with creatinine clearance <60mL / min / 1.73m2,
• clinically significant impairment of liver function (transaminase values 3 times the normal range),
• acute or chronic, clinically evident inflammatory process (diseases of connective tissue and joints, inflammatory processes of the respiratory tract, inflammatory processes of the genitourinary system, inflammation of the head and neck),
• acute infection in the last month,
• Cancer,
• alcohol abuse, drug addiction,
• taking medications that may interfere with test results,
• Taking antibiotics, steroids, antifungal and antiparasitic agents 4 weeks before the examination (not applicable to topical antifungal agents).
• taking pre - and / or probiotics in the last 12 weeks before the test
• travel to tropical countries in the last 4 weeks prior to the survey
• other conditions that may pose any risk to the patient during the follow-up.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Karolkiewicz, Prof

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Physical Education

Locations

Poznan University of Physical Education

Poznan, , Poland

Countries

Poland

Other Identifiers

PoznanUPhyEd Probiotyk

Identifier Type: -

Identifier Source: org_study_id