Next-Generation Synbiotic in Individuals With Overweight or Obesity

NCT06213480 | Unknown

• 1 other identifier: 2023-345
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (19)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Body Height (meters)

  Body height will be measured with a stadiometer.

  Measurement will take place at the first visit.

Study Arms (2)

Synbiotic Group

EXPERIMENTAL

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.

Dietary Supplement: Synbiotic Group

Placebo Group

PLACEBO COMPARATOR

They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo.

Other: Placebo Group

Interventions

Synbiotic Group DIETARY_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)

Also known as: The utilized synbiotic is Pendulum Glucose Control

Synbiotic Group

Placebo Group OTHER

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

Also known as: Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• be between 18-50 years of age
• have a BMI between 25.0-40.0

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Christian University: lead
• Pendulum Therapeutics: collaborator

Related 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.

  PMID: 31263284 BACKGROUND

• 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.

  PMID: 32675291 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Elisa Marroquin, Ph.D.

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Marroquin, Ph.D.

CONTACT

817-257-1031; E.Marroquin@tcu.edu

Ryan Porter, Ph.D.

CONTACT

817-257-6868; r.porter@tcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind study. Participants, the research staff, the PI, and the biostatistician will be all blinded. A university staff person who does not belong to the research team or the funding agency but has been CITI certified and approved by the IRB will hold the key of the assignment key.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sixty participants will be randomized into one of two groups: 1) 3-day antibiotic plus placebo for 3 months, or 2) 3-day antibiotic plus symbiotic for 3 months.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 19, 2024
• Study Start: January 10, 2024
• Primary Completion: December 20, 2024
• Study Completion: May 20, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available only after authors and co-authors have published the material of their interest.
• Access Criteria: Not available at this point. Recruitment has not started.