Next-Generation Synbiotic in Individuals With Overweight or Obesity

Texas Christian University60 enrolled

Overview

This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.

This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months. Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups. Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA. Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c. Body composition through DXA and BodPod will be measured before and after the symbiotic intervention. Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overweight and Obesity

Interventions

Synbiotic GroupDIETARY_SUPPLEMENT

WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions. Probiotic Ingredients: Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)

Placebo GroupOTHER

Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * be between 18-50 years of age * have a BMI between 25.0-40.0 Exclusion Criteria: * are following a vegetarian, vegan, carnivore, or keto diet * currently taking metformin, GLP-1 agonists, insulin, or fiber * have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month * pregnant, planning pregnancy during the study period, or lactating * have a history of inflammatory bowel disease, colon cancer, or chronic polyps * have been diagnosed with type 1 or type 2 diabetes * have active cancer * are currently participating in a weight loss intervention (dietetic or medication) * have used antibiotics, antifungals, or antivirals in the past 3 months * have had a history of recent (within 30 days) diarrhea illness * have a known allergy to any component of the study product * have had an acute inflammatory infection or inflammatory condition in the past 4 weeks * have had \>10% weight variation in the past 6 months * have had any bariatric surgery