Microbiota in health and diseases.
Kaijian Hou, Zhuo-Xun Wu, Xuan-Yu Chen...
https://pubmed.ncbi.nlm.nih.gov/35461318Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06901739
New Dietary Intervention Strategies on the Intestinal Microbiota to Improve Mental Health in Subjects With Obesity: Therapeutic Potential of a Synbiotic
Led by Celia Bañuls · Updated on 2025-08-05
120
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
C
Celia Bañuls
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the potential benefits of a synbiotic supplement, combining prebiotics and beneficial bacteria, for adults with obesity who may also experience anxiety or depression. The study aims to see if this supplement can change the gut microbiota and improve metabolic, inflammatory, intestinal, and appetite-related functions, along with mood and quality of life. It is a randomized, double-blind, placebo-controlled study involving 120 adults aged 18 to 65 with a BMI between 30 and 40, some with and some without psychological disorders, to better understand the gut-brain connection in obesity and mental health. Participants will be divided into groups receiving either the synbiotic supplement or a placebo daily for 12 weeks, alongside personalized nutritional counseling from a registered dietitian. The synbiotic contains specific strains of Lactobacillus and Bifidobacterium bacteria combined with tannin-based compounds. Both groups will follow a tailored hypocaloric diet, and psychological and nutritional follow-up assessments will be conducted throughout the study. Biological samples, including blood, saliva, urine, and stool, will be collected before and after the intervention for detailed analysis. During the study, participants will undergo body composition measurements, dietary and physical activity assessments, and psychological evaluations using standardized questionnaires. Researchers will measure numerous biochemical markers related to inflammation, antioxidant capacity, gut function, neurotransmitter levels, and the diversity and metabolic activity of the gut microbiota. Advanced techniques like gene expression analysis and organ-on-chip models will be used to study the gut-brain axis mechanisms. The study will last three years, focusing on microbiota diversity and mental health improvements as primary outcomes.
CONDITIONS
Brief Title
Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years
- Body mass index (BMI) between 30 and 40 kg/m²
- Diagnosed with obesity for at least 5 years
- Stable body weight with less than 5% change in the 3 months prior to the study
You will not qualify if you...
- Acute or chronic inflammatory diseases
- Neoplastic disease
- Secondary causes of obesity like uncontrolled hypothyroidism or Cushing's syndrome
- Established liver or kidney failure
- Previous bariatric surgery
- Pregnancy or lactation
- Use of antibiotics within 3 months before study
- Use of supplements containing probiotics or prebiotics before study
- Diagnosed intestinal diseases
- Other psychiatric disorders besides anxiety or depression
- Current treatment with antidepressants before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive a synbiotic supplement or placebo daily alongside a personalized hypocaloric diet guided by a registered dietitian to improve mental health and metabolic parameters in obesity.
Visits at baseline, and psychological follow-up visits at weeks 4, 6, and 12
Follow-up
Duration - Up to 3 years for long-term outcome measurements
Participants undergo assessments including blood, urine, saliva, and stool sample collection to evaluate biochemical, inflammatory, psychological, and microbiota changes after the intervention.
Periodic assessments post-intervention as scheduled by the study team
Trial Site Locations
Total: 1 location
1
FISABIO
Valencia, Valencia, Spain, 46020
Actively Recruiting
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Research Team
C
Celia Bañuls Morant, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Nevin Sanlier, Şule Kocabas
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https://pubmed.ncbi.nlm.nih.gov/31180143Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review.
Ricardo Fernandes, Vinicius A do Rosario, Michel C Mocellin...
https://pubmed.ncbi.nlm.nih.gov/27771020The Effects of Synbiotic Supplementation on Body Mass Index, Metabolic and Inflammatory Biomarkers, and Appetite in Patients with Metabolic Syndrome: A Triple-Blind Randomized Controlled Trial.
Samira Rabiei, Mehdi Hedayati, Bahram Rashidkhani...
https://pubmed.ncbi.nlm.nih.gov/29672196