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

NCT07269821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Alicante

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269821 on ClinicalTrials.gov