Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus

NCT05418179 | Unknown

• 1 other identifier: UFSC_2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus. Study hypothesis: Supplementation of multispecies probiotic (Bifidobacterium Lactis, B. brebe, B. longum, Lactobacillus gasseri, L. casei, L. rhamnosus) during 12 weeks improves the the fecal microbiota composition and promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with type 2 diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Fecal Microbiota

  analysis method: 16s rRNA sequencing and bioinformatics analysis. Reported measure: taxonomic profiles of the microbial populations (operational taxonomic units / OTUs)

  12 weeks compared to baseline

• SCFA

  Acetate, propionate, isobutyrate, butyrate and isovalerate (μmol/L)

  12 weeks compared to baseline

• Inflammatory parameters

  Plasma LPS, adiponectin, leptin, resistin, IL-1, IL-6, IL-8, IL-10 and TNF-alpha concentrations (pg/mL)

  12 weeks compared to baseline

Secondary Outcomes (16)

• Fasting insulin

  12 weeks compared to baseline

• fasting blood glucose

  12 weeks compared to baseline

• HOMA-IR

  12 weeks compared to baseline

• Glycated hemoglobin

  12 weeks compared to baseline

• Free Fat Acids

  12 weeks compared to baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin (1 capsule/day)

Dietary Supplement: Placebo

Probiotic

ACTIVE COMPARATOR

Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day

Probiotic

Placebo DIETARY_SUPPLEMENT

Maltodextrin (1 capsule/day)

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 35 to 75 years old;
• Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago);
• Body mass index from 25.00 kg/m² to 39.99 kg/m²;
• Glycated hemoglobin ≤ 9.0% ;
• Using metformin, combined or not with other antidiabetic drugs

You may not qualify if:

• Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy)
• Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease);
• Glomerular filtration rate \<30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies;
• Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation);
• Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study;
• Regular use of laxatives, opioid narcotic analgesics or appetite suppressants;
• Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements;
• Intolerance to prebiotics, probiotics or symbiotics;
• Pregnant or breastfeeding;
• Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic);
• Alcohol consumption (\> 1 drink/day or 14g of alcohol for women; \>2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers;
• Change of lipid-lowering and/or antidiabetic drugs in the last 3 months

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Polydoro Ernani de São Thiago University Hospital

Florianópolis, Santa Catarina, 88036-800, Brazil

RECRUITING

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

Central Study Contacts

Erasmo Trindade, PhD

CONTACT

+55 48 3721-3489; erasmotrindade@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study participants and researchers were masked over consumption and distribution of supplementation, respectively. Laboratory technicians who performed the blood collection were also masked as to the distribution of supplementation. Supplements and placebo were pre-packaged by the supplier in opaque and closed sachets with randomization codes, being identical in physical appearance, taste and color. Supplement identification codes were only disclosed by the supplier after statistical analysis of study data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 14, 2022
• Study Start: December 1, 2021
• Primary Completion: December 20, 2023
• Study Completion: December 24, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

BR (1)