Actively Recruiting
Clinical Evaluation of a Postbiotic Supplement in Overweight and Obese Adults: A Randomized Controlled Trial
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2026-02-19
114
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a postbiotic supplement on body composition and other health factors in overweight or obese adult men and women. The study aims to observe changes in body weight, glucose tolerance, gut microbiota, metabolites, biochemical markers related to metabolism and obesity, physical activity levels, and adherence to nutritional recommendations. This randomized controlled trial involves 114 participants, including a 10% allowance for dropout. Participants will be randomly assigned to one of two groups for 12 weeks: an experimental group receiving nutritional advice plus a daily gummy containing a postbiotic supplement, and a placebo group receiving nutritional advice plus a daily gummy without the active supplement. They will visit the nutritional intervention unit at the start and end of the 12-week period, with a follow-up phone call at week 6. During the study, participants will attend two clinical visits where body measurements, blood pressure, and samples of blood, urine, and stool will be collected. Researchers will also gather data on diet, physical activity, sleep, and gastrointestinal symptoms. The main outcome measured is body fat percentage, with various secondary measures including glucose levels, cholesterol, inflammation markers, gut microbiota, and quality of life. Participants' adherence to the supplement and nutritional guidelines will be monitored throughout the study.
CONDITIONS
Brief Title
Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 70 years.
- Overweight or obese with BMI between 27 and 39.9 kg/m2.
- Body fat percentage of at least 30% for women and 20% for men.
- Stable body weight (±5%) for at least three months before the study.
- Normal physical exam and vital signs or no clinically relevant findings.
- Ability to understand and sign informed consent and comply with study procedures.
- Stable pharmacological or hormonal treatment that does not affect study parameters (no insulin or hypoglycemic drugs).
- Willingness to consume one 1 g gummy daily during the 12-week intervention.
- Availability to attend two on-site clinical visits and a 3-hour session at visit 2.
You will not qualify if you...
- Unstable pharmacological treatment or treatments affecting gastrointestinal function.
- Chronic use of stomach protectors.
- Use of hypoglycemic drugs or insulin.
- Significant digestive system abnormalities or chronic digestive diseases.
- Surgical interventions causing permanent digestive tract changes or bariatric surgery.
- Chronic metabolic diseases or obesity-related conditions (except non-alcoholic fatty liver disease).
- Alcohol consumption exceeding 14 units/week for women or 20 units/week for men.
- Pregnant, breastfeeding, or planning pregnancy.
- Use of nutritional supplements affecting study outcomes without a 15-day washout.
- Blood donation within 14 days before baseline.
- Cancer diagnosis or treatment within the last 5 years.
- Allergies to study product components or interfering foods.
- Cognitive or psychiatric impairments.
- Poor compliance or difficulty adhering to study procedures.
- Current weight loss or body composition treatments.
- Antibiotic use within 60 days before baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 12 weeks
Participants consume one gummy daily containing either a postbiotic or placebo formulation along with healthy nutritional recommendations for 12 weeks. Two clinical investigation visits will be conducted to assess body composition, blood pressure, and collect blood, urine, and stool samples, as well as record data on diet, physical activity, sleep, and gastrointestinal symptoms.
2 visits (in-person): one at the start and one at the end of the 12-week intervention
Trial Site Locations
Total: 1 location
1
Center for Nutrition Research
Pamplona, Navarre, Spain
Actively Recruiting
Research Team
P
Paula Aranaz, PhD
F
Fermín Milagro, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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