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Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults

Primary Purpose

Obesity, Obesity; Endocrine, Overweight and Obesity

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic blend
Placebo
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring obesity, probiotic, supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of Free and Informed Consent in writing, signed and dated; Age according to the indicated population (18-65 years old) both genders; Body mass index (BMI) of 25 - 35 Kg/m2. Exclusion Criteria: Pregnant and lactating women Individuals with a history of daily consumption of probiotics, fermented milk and/or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product; Individuals with concomitant participation in another clinical trial; History of autoimmune, cardiovascular, thyroid, or chronic liver disease; Making use of medication capable of affecting weight change, antidiabetic medication, hypolipidemic agents; Individuals who have undergone weight loss surgery, Weight change greater than 5% in the last three months.

Sites / Locations

  • Universidade do Extremo Sul CatarinenseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probiotic Blend

Arm Description

Volunteers supplemented with maltodextrin

Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858 - Final concentration: 1 x 10e10 UFC/ day

Outcomes

Primary Outcome Measures

Body fat composition by Bioelectrical impedance analysis
By Bioelectrical impedance analysis (BIA). This is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body.

Secondary Outcome Measures

Total cholesterol by blood analyses
biochemical analyses before and after inclusion: Total cholesterol to be carried out in a reference laboratory. Total cholesterol will be measured in mg/dL
quality of life questionnaire score
quality of life and improvement of gastrointestinal symptoms by SF-36 scale (It comprises 36 questions that cover eight domains of health)
Gastrointestinal Symptom Rating Scale (GSRS) questionnaire score
GSRS scale: An interview-based rating scale consisting of 15 items for assessment of gastrointestinal symptoms
Weight
weight will be measured in kilograms
height
height will be measured in centimeters
HDL levels by blood analyses
biochemical analyses before and after inclusion: HDL to be carried out in a reference laboratory. HDL will be measured in mg/dL
LDL levels by blood analyses
biochemical analyses before and after inclusion: LDL to be carried out in a reference laboratory. LDL will be measured in mg/dL
triglycerides levels by blood analyses
biochemical analyses before and after inclusion: triglycerides to be carried out in a reference laboratory. triglycerides will be measured in ml/dL
Glucose levels by blood analyses
biochemical analyses before and after inclusion: glucose to be carried out in a reference laboratory. glucose will be measured in mg/dL

Full Information

First Posted
December 9, 2022
Last Updated
February 19, 2023
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
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1. Study Identification

Unique Protocol Identification Number
NCT05676229
Brief Title
Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults
Official Title
The Use of a Probiotic Blend in Reducing Anthropometric Measurements and Improving Biochemical Parameters in Adults With Overweight and/or Obese
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
February 19, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is already known that dysbiosis, that is, qualitative and quantitative changes in the composition of the intestinal microbiota, can be associated with the development of a series of intestinal and extra-intestinal disorders. Dysbiosis is reported in irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, allergic diseases, non-alcoholic steatohepatitis, arteriosclerotic diseases, neurological diseases and metabolic syndromes, mainly diabetes and obesity. Among the many factors that play a key role in obesity, a number of studies show the intestinal microbiota as an important contributor. Many studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of obesity. Furthermore, it is found that benefits for body weight, abdominal adiposity, anthropometric measurements and body composition are often associated with favorable metabolic effects.
Detailed Description
Obesity is defined as excessive accumulation of body fat, caused by an energy imbalance. Approximately 13% of the world's adult population is obese, and in Brazil 19.8% of adults are obese. This disease is a risk factor for the development of other non-communicable chronic diseases (NCDs), such as: type 2 diabetes mellitus (DM2), dyslipidemia, cardiovascular diseases, musculoskeletal disorders and some types of cancer. It is a complex and multifactorial disease, which is why it is considered difficult to control and a cause for global concern. Among the causes of the disease, genetic, environmental and psychological factors can be mentioned, in addition to the interference of the intestinal microbiota, among others. The interaction of the intestinal microbiota with the host has been studied through metabolomics, in order to understand the influence that the microbiota can exert on the functioning of the host organism. The study of the profile of low molecular weight metabolites of biological fluids such as serum/plasma and urine aims to understand the metabolic changes that occur in individuals with obesity, encompassing the understanding of the mechanisms of the disease. Studies have shown differences in the metabolic profile of obese individuals compared to eutrophic individuals, with a positive correlation between body mass index (BMI) and increased concentrations of chain amino acids (BCAA) and glutamate. The gut microbiota appears to play a crucial role in host metabolism, being a pathway through which it leads to changes associated with obesity. In this context, the intestinal microbiota can be modulated by prebiotics, probiotics and symbiotics, promoting changes in its composition, resulting in the regeneration of the intestinal barrier and, with that, ceasing metabolic endotoxemia and low-grade inflammation. In addition, they have effects on the modulation of the immune system, regulating the production of pro and anti-inflammatory cytokines, reducing IR. Through these mechanisms, probiotics and symbiotics alter the microbiota profile of individuals leading to loss of body weight and metabolic parameters associated with obesity. Several studies have shown beneficial effects of using probiotics on body weight, glycemic control, improvement in lipid profile and blood pressure (BP). However, there are controversies about which are the best strains for this purpose. There are five systematic reviews currently published with or without meta-analysis that address the effect of using different probiotics on body weight. Among the strains associated with weight loss and/or adiposity, L. plantarum associated with L. rhamnosus and hypocaloric diet stand out; L. plantarum with L. curvatus; L. gasseri; L. amylovorus; L. acidophilus and L. casei associated with phenolic compounds; or Lactobacillus mix.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity; Endocrine, Overweight and Obesity, Overweight, Obesity and Other Hyperalimentation
Keywords
obesity, probiotic, supplement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomised, triple-blind, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Volunteers supplemented with maltodextrin
Arm Title
Probiotic Blend
Arm Type
Active Comparator
Arm Description
Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858 - Final concentration: 1 x 10e10 UFC/ day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic blend
Intervention Description
Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin only (vehicle)
Primary Outcome Measure Information:
Title
Body fat composition by Bioelectrical impedance analysis
Description
By Bioelectrical impedance analysis (BIA). This is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Total cholesterol by blood analyses
Description
biochemical analyses before and after inclusion: Total cholesterol to be carried out in a reference laboratory. Total cholesterol will be measured in mg/dL
Time Frame
three months
Title
quality of life questionnaire score
Description
quality of life and improvement of gastrointestinal symptoms by SF-36 scale (It comprises 36 questions that cover eight domains of health)
Time Frame
three months
Title
Gastrointestinal Symptom Rating Scale (GSRS) questionnaire score
Description
GSRS scale: An interview-based rating scale consisting of 15 items for assessment of gastrointestinal symptoms
Time Frame
three months
Title
Weight
Description
weight will be measured in kilograms
Time Frame
three months
Title
height
Description
height will be measured in centimeters
Time Frame
three months
Title
HDL levels by blood analyses
Description
biochemical analyses before and after inclusion: HDL to be carried out in a reference laboratory. HDL will be measured in mg/dL
Time Frame
three months
Title
LDL levels by blood analyses
Description
biochemical analyses before and after inclusion: LDL to be carried out in a reference laboratory. LDL will be measured in mg/dL
Time Frame
three months
Title
triglycerides levels by blood analyses
Description
biochemical analyses before and after inclusion: triglycerides to be carried out in a reference laboratory. triglycerides will be measured in ml/dL
Time Frame
three months
Title
Glucose levels by blood analyses
Description
biochemical analyses before and after inclusion: glucose to be carried out in a reference laboratory. glucose will be measured in mg/dL
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of Free and Informed Consent in writing, signed and dated; Age according to the indicated population (18-65 years old) both genders; Body mass index (BMI) of 25 - 35 Kg/m2. Exclusion Criteria: Pregnant and lactating women Individuals with a history of daily consumption of probiotics, fermented milk and/or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product; Individuals with concomitant participation in another clinical trial; History of autoimmune, cardiovascular, thyroid, or chronic liver disease; Making use of medication capable of affecting weight change, antidiabetic medication, hypolipidemic agents; Individuals who have undergone weight loss surgery, Weight change greater than 5% in the last three months.
Facility Information:
Facility Name
Universidade do Extremo Sul Catarinense
City
Criciúma
State/Province
Santa Catarina
ZIP/Postal Code
88806-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Michels
Phone
+55 48 996274651
Email
monique@biohall.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults

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