Next-Generation Synbiotic in Individuals With Overweight or Obesity

Overweight and Obesity Clinical Trial

Official title:

Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity: A Triple-Blinded Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213480
• Other study ID #: 2023-345
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: May 20, 2025

Study information

• Verified date: January 2024
• Source: Texas Christian University
• Contact: Elisa Marroquin, Ph.D.
• Phone: 817-257-1031
• Email: E.Marroquin[@]tcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Synbiotic Group
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)

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas Christian University	Pendulum Therapeutics

References & Publications (2)

Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1. — View Citation

Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319. — View Citation

Outcome

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