Actively Recruiting
Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2).
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2026-02-19
114
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The principal objective of this project is to evaluate the effect of a postbiotic supplement (inactivated microorganism) on body composition and other physiological and metabolic parameters related to excess body weight in overweight or obese adult men and women, as well as to determine changes in the gut microbiota associated with these outcomes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters: * Changes in body weight and composition. * Changes in glucose tolerance. * Changes in gut microbiota (metagenomics). * Changes in urinary and serum metabolites. * Changes in routine biochemical variables related to carbohydrate and lipid metabolism, as well as liver parameters. * Changes in specific markers involved in obesity pathology, such as insulin, leptin, adiponectin, and cytokines MCP-1, TNF, CRP, and others. * Adherence to the nutritional recommendations and the gummy containing postbiotic formula. * Changes in the level of physical activity. Target sample size is 114 subjects, including a 10% of drop out. Participants will be allocated in two groups for 12 weeks: * Experimental group (n=57): nutritional recommendations + postbiotic supplement/gummy. * Placebo group (n=57): nutritional recommendations + placebo supplement/gummy. Participants will visit the nutritional intervention unit at weeks 1 and 12. A follow-up phone call will be conducted at week 6.
CONDITIONS
Official 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 volunteers 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 (±15%) for at least three months before study start.
- Normal physical exams and vital signs or clinically non-relevant findings.
- Ability to understand and sign informed consent.
- Willingness to comply with study procedures and daily consumption of a 1 g gummy.
- Stable pharmacological/hormonal treatment for at least three months if applicable, excluding insulin or drugs with hypoglycemic effects.
- Availability to attend two on-site clinical evaluation sessions, including one 3-hour session.
You will not qualify if you...
- Unstable pharmacological treatment within three months before study start.
- Treatments altering gastrointestinal function or chronic use of stomach protectors.
- Use of hypoglycemic drugs or insulin.
- Significant digestive system abnormalities or diseases.
- History of digestive tract surgery with permanent effects or bariatric surgery.
- Chronic metabolic diseases or obesity-related conditions, including type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia.
- Excessive alcohol consumption (over 14 units/week for women, 20 units/week for men).
- Pregnancy, breastfeeding, or planning pregnancy.
- Use of nutritional supplements affecting study outcomes without agreed discontinuation.
- Blood donation within 14 days before baseline.
- History of cancer or ongoing cancer treatment within the past 5 years.
- Allergy to study product components or interfering foods.
- Cognitive or psychiatric impairments.
- Poor compliance or difficulty adhering to study procedures.
- Current treatment for weight loss or body composition changes.
- Antibiotic use within 60 days before baseline visit.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Nutrition Research
Pamplona, Navarre, Spain
Actively Recruiting
Research Team
P
Paula Aranaz, PhD
CONTACT
F
Fermín Milagro, PhD
CONTACT
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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