Next-Generation Synbiotic in Individuals With Overweight or Obesity

Not Applicable

Not yet recruiting

• Conditions: Overweight and Obesity
• Interventions: Other: Placebo Group; Dietary Supplement: Synbiotic Group

• Registration Number: NCT06213480
• Lead Sponsor: Texas Christian University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-12-20
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study Start: 2024-01-10
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-12-20
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Group	They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo.
Synbiotic Group	Synbiotic Group	They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber.

Primary Outcome Measures

Name	Time	Method
Fat Mass to Height (kg/m2)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body fat mass by using DXA analysis.
Fat Mass (kg)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body fat mass by using BodPod analysis.
Fat Free Mass (Kg)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body lean mass by using BodPod analysis.
Visceral Fat Volume (cm3)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body visceral mass by using DXA and BodPod analysis.
Fasting Insulin (mIU/L)	Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.	We will measure fasting insulin after a 12h fast.
Anxiety (number in 0-63 scale)	These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.	We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels.
Depression (number in 0-63 scale)	These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.	We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression.
Gut Microbial Composition (depending on funding availability at the time of analysis)	Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.	We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes.
Fat Free Mass (%)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body lean mass by using BodPod analysis.
Body Height (meters)	Measurement will take place at the first visit.	Body height will be measured with a stadiometer.
Total Body Fat Mass through DXA (percentage)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body fat mass by using DXA analysis.
Total Body Fat Mass through BodPod (percentage)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body fat mass by using BodPod analysis.
Body Lean Mass to Height (kg/m2)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body lean mass by using DXA analysis.
Visceral Fat Mass (grams)	These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.	We will measure body visceral mass by using DXA and BodPod analysis.
Fasting Glucose (mg/dL)	Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.	We will measure fasting glucose after a 12h fast.
Food cravings (number in 0-52 scale)	These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.	We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings.
HbA1c (%)	Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.	We will measure HbA1c after a 12h fast.
Blood Microbial Composition (depending on funding availability at the time of analysis)	Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.	We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes.
Body Weight (kg)	Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.	Body weight will be measured with a calibrated scale.