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).
Those that alter gastrointestinal function.
Chronic use of stomach protectors.
Any hypoglycemic drugs or insulin.
Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.
Parallel
Postbiotic + nutritional recommendations
Dietary supplementStudy participants will consume daily one gummy containing a postbiotic formulation, along with adherence to healthy nutritional recommendations for 12 weeks.
Placebo + nutritional recommendations
Dietary supplementStudy participants will consume daily one gummy containing a placebo formulation, along with adherence to healthy nutritional recommendations for 12 weeks.
Body fat mass percentage
Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.
Body weight
Weight of participants will be measured by bioimpedance and reported in kg
Height
Height of participants will be measured by stadiometer and reported in m.
Body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2
Body lean mass
Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms.
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