Clinical Trials Logo
  1. Home
  2. Adiposity
  3. NCT02151825

Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects

Gut Microbiota Clinical Trial

Official title:
Pilot Study on the Influence of a Synbiotic Formulation (ProSynbiotic) on Gut Microbiota Composition, Adiposity and Selected Markers of Cardiometabolic Health in Overweight or Moderately Obese Individuals

Clinical Trial Summary

The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the gut microbiota composition, body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects.

Clinical Trial Description

This is a parallel, double-blind, randomized, placebo controlled trial to determine the effects of a synbiotic formulation (ProSynbiotic) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota composition, body composition, expression of genes mediating dietary energy harvest and adiposity, and on adiposity-related metabolic markers in healthy free-living overweight or moderately obese subjects. The duration of the study is 18 weeks, including a 2-week run-in period before randomization of subjects into the synbiotic or placebo group, a 12-week intervention period, and a 4-week follow-up after the end of the intervention. During the intervention period, subjects will be instructed to take 3 capsules of either synbiotic or placebo per day and maintain their habitual diet and physical activity. They will also be asked to document any unusual symptoms or side effects as well as keep a bowel diary. Diet and physical activity will be monitored via 24-h dietary recalls and the global physical activity questionnaire respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels in stool sampled collected at baseline, 6 weeks, 12 weeks and the follow up time point. Body composition will be measured using the BOD POD at baseline, 6 weeks, and 12 weeks. Gene expression levels will be assessed at baseline and 12 weeks in colonocytes (isolated from stool samples) and PBMCs (isolated from blood samples) by qPCR. Metabolic markers will be measured at baseline and 12-weeks in plasma or serum using the respective biochemical- or immuno-assays. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02151825
Study type Interventional
Source Texas State University, San Marcos
Contact
Status Completed
Phase N/A
Start date September 2011
Completion date October 2012
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04991792 - Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section N/A
Completed NCT01545219 - A Study of a Prebiotic, a Probiotic and a Synbiotic Upon the Gut Microbiota and Immune Response of Healthy Volunteers N/A
Active, not recruiting NCT04435548 - Westlake Gut Microbiome Study
Enrolling by invitation NCT05057039 - The Study of Gut Microbiota in Hypertensive Patients
Not yet recruiting NCT05039060 - Modified MAC Diet and Gut Microbiota in CRC Patients N/A
Completed NCT03746158 - Interindividual Variation in Excretion of Curcumin N/A
Active, not recruiting NCT03266055 - Effects of Blueberry on Gut Microbiota and Metabolic Syndrome N/A
Completed NCT04960878 - The Effect of Synbiotics on the Upper Respiratory Tract Infection N/A
Active, not recruiting NCT05607745 - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study N/A
Recruiting NCT04120051 - The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults N/A
Not yet recruiting NCT05481866 - Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum N/A
Completed NCT03293693 - Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects N/A
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Recruiting NCT04203459 - The Mechanism of Enhancing the Anti-tumor Effects of CAR-T on PC by Gut Microbiota Regulation
Active, not recruiting NCT03259685 - Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome N/A
Recruiting NCT06157346 - Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
Completed NCT03203044 - Impact of Soylent Consumption on Human Microbiome Composition N/A
Recruiting NCT05975541 - Susceptibility to Infectious Diseases in Obesity
Active, not recruiting NCT05457439 - Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment N/A
Recruiting NCT05008120 - Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder