CompletedNot Applicable

Evaluation of a Nutritional Intervention With Dietary Supplements in People Who Have Recently Lost Weight: Effects on Body Composition, Emotional Health, and Gut Microbiota

Spain70 participantsStarted 2025-07-01

Plain-language summary

This study aims to evaluate the effects of a 12-week nutritional intervention with dietary supplements on individuals who have experienced significant weight loss following the use of GLP-1 receptor agonists or similar weight-loss treatments. The study will investigate whether the combined supplementation protocol can improve body composition, emotional well-being, and gut microbiota diversity after discontinuation of pharmacological treatment. Participants will be randomly assigned to one of two groups: an intervention group receiving a daily combination of food supplements containing bioactive compounds (including polyphenols, prebiotics, and antioxidants) and a placebo group. Both groups will maintain their habitual diet and lifestyle throughout the study. Primary outcomes include changes in fat-free mass, emotional state, and gut microbiota composition. Secondary outcomes include metabolic markers, appetite regulation, and quality of life indicators. This project seeks to provide evidence-based strategies for maintaining health and preventing metabolic rebound following rapid weight loss or pharmacologically induced appetite suppression.

Who can participate

Age range25 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 25 to 60 years. * Documented unintentional or pharmacologically induced weight loss of ≥5% during the previous 3 months. * Stable body weight (±2 kg variation) during the 2 weeks prior to enrollment. * Completion or discontinuation of GLP-1 receptor agonist or other pharmacological weight-loss therapy within the last 3 months. * Willingness to maintain habitual dietary and physical activity habits throughout the study. * Ability to provide written informed consent and comply with all study procedures. Exclusion Criteria: * Current or recent use (within 3 months) of antibiotics, probiotics, or prebiotic supplements. * Active gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease, chronic diarrhea, or severe constipation). * Diagnosis of diabetes mellitus, cardiovascular disease, cancer, liver, or kidney dysfunction. * Pregnancy, breastfeeding, or intention to become pregnant during the study period. * Psychiatric disorders or use of medications affecting mood or appetite. * Participation in another clinical trial during the previous 3 months. * Any condition that, in the investigator's opinion, could interfere with study participation or interpretation of results.

What they're measuring

Change in Fat Mass (%)

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT07269821

SponsorUniversity of Alicante

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31