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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus: Study Protocol for a Triple-blind Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418179
• Other study ID #: UFSC_2021
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 24, 2023

Study information

• Verified date: March 2023
• Source: Universidade Federal de Santa Catarina
• Contact: Erasmo Trindade, PhD
• Phone: +55 48 3721-3489
• Email: erasmotrindade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to evaluate the effect of multispecies probiotic supplementation (specifically designed for the present study) on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus (T2DM).

Adult individuals (35 to 75 years old) of both sexes with T2DM (diagnosed at least 1 year ago), body mass index from 25.00 kg/m² to 39.99 kg/m², glycated hemoglobin ≤ 9.0% and using metformin will be invited to participate in this randomized, placebo-controlled, triple-blind study.

The participants will be randomized into two groups: G1 - probiotic group and G2 - control group (placebo).

The study will consist of two experimental time points: M0 - baseline and start of supplementation; M1 - after 12 weeks of the first outpatient visit and start of supplementation.

In the two experimental moments, individual fecal samples will be obtained for analysis of the fecal microbiota; The metabolic parameters will be assessed by determination of circulating levels of SCFA, FFA, insulin, fasting glucose and glycated hemoglobin, HOMA-IR; Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; the inflammatory response will be assessed by determination of plasma indicadors (LPS, Adiponectina, IL-10, IL-1, IL-6, TNF- α, Leptina, Resistina) ; besides the evaluation of indicators of nutritional status (bone densitometry with body composition and anthropometric measurements).

The primary endpoint will be the fecal microbiota composition, SCFA concentrations and the inflammatory parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 24, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Probiotic
Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day
• Placebo
Maltodextrin (1 capsule/day)

Locations

Country	Name	City	State
Brazil	Polydoro Ernani de São Thiago University Hospital	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	SCFA	Acetate, propionate, isobutyrate, butyrate and isovalerate (µmol/L)	12 weeks compared to baseline
Primary	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	Fasting insulin	µUI/mL	12 weeks compared to baseline
Secondary	fasting blood glucose	mg/dL	12 weeks compared to baseline
Secondary	HOMA-IR	HOMA-IR = [fasting blood glucose (mmol) x fasting insulin (UI/ml)] ÷ 22,5	12 weeks compared to baseline
Secondary	Glycated hemoglobin	percentage (%)	12 weeks compared to baseline
Secondary	Free Fat Acids	µmol/L	12 weeks compared to baseline
Secondary	Triglycerides	mg/dL.	12 weeks compared to baseline
Secondary	Total cholesterol	mg/dL	12 weeks compared to baseline
Secondary	LDL-c	(Friedewald equation) LDL-c = total colesterol - HDL-c - Triglicerídeos/5; Reported measure: mg/dL	12 weeks compared to baseline
Secondary	HDL-c	mg/dL	12 weeks compared to baseline
Secondary	Bone densitometry	Dual X-ray Absorptiometry (DXA). Reported measure: T-score and Z-score	12 weeks compared to baseline
Secondary	Body weight (kg)	kilograms	12 weeks compared to baseline
Secondary	Waist circumference (cm)	centimeters (cm)	12 weeks compared to baseline
Secondary	Body mass index (BMI)	In metric units: BMI (kg/m²) = weight (kg) ÷ height² (meters). Reported measure: kg/m².	12 weeks compared to baseline
Secondary	Total Body Fat Percentage (%BF)	Dual X-ray Absorptiometry (DXA). Reported measure: Total Body Fat Percentage (%BF)	12 weeks compared to baseline
Secondary	Fat Mass Index (FMI)	Dual X-ray Absorptiometry (DXA) - Fat Mass Index (FMI) - the total amount of fat (in kilograms) relative to the height (in meters²)	12 weeks compared to baseline
Secondary	Total Body lean mass Percentage (%)	Dual X-ray Absorptiometry (DXA) - Total Body lean mass Percentage (%): The percent of the body that is not composed of fat.	12 weeks compared to baseline