Clinical trial NCT06213480: Next-Generation Synbiotic in Individuals With Overweight or Obesity
Official title: Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity: A Triple-Blinded Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Texas Christian University
Sponsor class: OTHER
Collaborators: name: Pendulum Therapeutics
First posted: 2024-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Body Fat Mass through DXA (percentage)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Total Body Fat Mass through BodPod (percentage)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Fat Mass to Height (kg/m2)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Fat Mass (kg)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Body Lean Mass to Height (kg/m2)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Fat Free Mass (%)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Fat Free Mass (Kg)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Visceral Fat Volume (cm3)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Visceral Fat Mass (grams)
timeFrame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
measure: Fasting Glucose (mg/dL)
timeFrame: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
measure: Fasting Insulin (mIU/L)
timeFrame: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
measure: HbA1c (%)
timeFrame: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
measure: Anxiety (number in 0-63 scale)
timeFrame: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
measure: Depression (number in 0-63 scale)
timeFrame: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
measure: Food cravings (number in 0-52 scale)
timeFrame: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
measure: Gut Microbial Composition (depending on funding availability at the time of analysis)
timeFrame: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
measure: Blood Microbial Composition (depending on funding availability at the time of analysis)
timeFrame: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
measure: Body Weight (kg)
timeFrame: 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.
measure: Body Height (meters)
timeFrame: Measurement will take place at the first visit.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Texas Christian University
name: Elisa Marroquin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.