NCT07269821

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Alicante · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The increasing use of GLP-1 receptor agonists and similar drugs has led to significant weight loss in many individuals; however, this is often followed by loss of lean mass, mood alterations, and gut microbiota imbalance. This study explores a nutritional supplementation strategy designed to support metabolic recovery and preserve physiological homeostasis in this population. This 12-week randomized, double-blind, placebo-controlled clinical trial will include adults aged 25-60 years who have recently lost ≥5% of body weight due to pharmacological treatment or restrictive dietary patterns. Participants will be randomly assigned to one of two groups: 1. Experimental Group: Daily intake of a multi-component dietary supplement containing polyphenols, prebiotic fibers, and natural extracts with antioxidant and anti-inflammatory properties. 2. Placebo Group: Daily intake of an inert product with identical appearance, taste, and packaging. All participants will continue their usual dietary and lifestyle habits. Compliance will be monitored through periodic visits and digital tracking. Measurements will be taken at baseline and after 12 weeks, including: * Body composition: fat mass, fat-free mass, and phase angle. * Blood biomarkers: glucose, lipids, liver enzymes, and inflammatory markers. * Psychological parameters: mood, anxiety, and quality of life scales. * Gut microbiota: analysis of microbial diversity and composition from stool samples. The expected outcome is that the supplement will mitigate lean mass loss, improve emotional balance, and restore microbiota diversity after significant weight reduction. Results from this study may contribute to developing safe and effective strategies for post-weight-loss management and metabolic health maintenance.

Conditions

• GLP-1
• Weight Loss Trajectory
• Emotional Disorder
• Microbiota Balance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Metabolaid®-based nutraceutical formulation	A 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss.
DIETARY_SUPPLEMENT	Placebo capsules	A 12-week placebo supplementation with capsules identical in appearance to the experimental product, to evaluate differences in body composition, gut microbiota, and emotional parameters.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2025-12-08
• Last updated: 2025-12-24

Locations

1 site across 1 country: Spain