Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults

NCT ID: NCT05676229

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2023-12-30

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.

Conditions

Obesity; Obesity; Endocrine; Overweight and Obesity; Overweight, Obesity and Other Hyperalimentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Volunteers supplemented with maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin only (vehicle)

Probiotic Blend

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

Group Type: ACTIVE_COMPARATOR

Probiotic blend

Intervention Type: DIETARY_SUPPLEMENT

Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858

Interventions

Probiotic blend

Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin only (vehicle)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

OTHER

Sponsor Role: lead

Responsible Party

Monique Michels

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Monique Michels

Role: primary

monique@biohall.com.br

+55 48 996274651

Other Identifiers

65117022.1.0000.0119

Identifier Type: -

Identifier Source: org_study_id