Clinical Evaluation of a Postbiotic Supplement in Overweight and Obese Subjects: A Randomized Controlled Trial.
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.
• Male and female participants aged 18 to 70 years.
• Volunteers with overweight or obesity (BMI: ≥ 27-39.9 kg/m²) and a body fat percentage of ≥ 30% for women and ≥ 20% for men.
• Stable body weight (±5%) for at least the three months prior to study initiation.
• Normal physical examination and vital signs, or clinically non-relevant findings for the purposes of the study (i.e., not related to metabolic health).
• Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements.
• Continued pharmacological/hormonal treatment will be permitted provided it does not affect the study parameters and that the dosage has remained stable at least the previous three months to the start of the intervention. Treatment with insulin or any drug with a hypoglycemic effect will be excluded
• Willingness to undergo all study procedures (including the daily consumption of a 1 g gummy during the intervention).
• Time and geographic availability to attend the two on-site clinical evaluation sessions at the scheduled times (including a 3-hour session during visit 2).