Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults

NCT05676229 | Unknown Phase 2 DMC

• 1 other identifier: 65117022.1.0000.0119
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

obesity; probiotic; supplement

Outcome Measures

Primary Outcomes (1)

• 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.

  three months

Secondary Outcomes (9)

• Total cholesterol by blood analyses

  three months

• quality of life questionnaire score

  three months

• Gastrointestinal Symptom Rating Scale (GSRS) questionnaire score

  three months

• Weight

  three months

• height

  three months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Volunteers supplemented with maltodextrin

Dietary Supplement: Placebo

Probiotic Blend

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic blend

Interventions

Probiotic blend DIETARY_SUPPLEMENT

Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858

Probiotic Blend

Placebo DIETARY_SUPPLEMENT

Maltodextrin only (vehicle)

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88806-000, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomised, triple-blind, placebo-controlled trial

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 9, 2023
• Study Start: January 11, 2023
• Primary Completion: February 19, 2023
• Study Completion: December 30, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

BR (1)