Clinical trial NCT05418179: Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal Microbiota
timeFrame: 12 weeks compared to baseline
measure: SCFA
timeFrame: 12 weeks compared to baseline
measure: Inflammatory parameters
timeFrame: 12 weeks compared to baseline
Secondary outcomes:
measure: Fasting insulin
timeFrame: 12 weeks compared to baseline
measure: fasting blood glucose
timeFrame: 12 weeks compared to baseline
measure: HOMA-IR
timeFrame: 12 weeks compared to baseline
measure: Glycated hemoglobin
timeFrame: 12 weeks compared to baseline
measure: Free Fat Acids
timeFrame: 12 weeks compared to baseline
measure: Triglycerides
timeFrame: 12 weeks compared to baseline
measure: Total cholesterol
timeFrame: 12 weeks compared to baseline
measure: LDL-c
timeFrame: 12 weeks compared to baseline
measure: HDL-c
timeFrame: 12 weeks compared to baseline
measure: Bone densitometry
timeFrame: 12 weeks compared to baseline
measure: Body weight (kg)
timeFrame: 12 weeks compared to baseline
measure: Waist circumference (cm)
timeFrame: 12 weeks compared to baseline
measure: Body mass index (BMI)
timeFrame: 12 weeks compared to baseline
measure: Total Body Fat Percentage (%BF)
timeFrame: 12 weeks compared to baseline
measure: Fat Mass Index (FMI)
timeFrame: 12 weeks compared to baseline
measure: Total Body lean mass Percentage (%)
timeFrame: 12 weeks compared to baseline
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Polydoro Ernani de São Thiago University Hospital
state: Santa Catarina
Study officials:
References: