Evaluation of a Nutritional Intervention With Dietary Supplements in People Who Have Recently Lost Weight: Effects on Body Composition, Emotional Health, and Gut Microbiota
NCT ID: NCT07269821
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2025-07-01
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: Experimental - Dietary supplement
Participants will receive a daily dose of a nutraceutical formulation designed to support weight maintenance and metabolic recovery after weight loss.
The supplement contains Metabolaid® (a standardized extract of Hibiscus sabdariffa and Lippia citriodora) aimed at improving gut microbiota composition, emotional well-being, and preserving fat-free mass.
The intervention lasts 12 weeks, with two capsules per day, taken with meals.
Metabolaid®-based nutraceutical formulation
A 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss.
Arm 2: Placebo - Control
Participants will receive a placebo identical in appearance, taste, and packaging to the active supplement.
The placebo capsules contain inert excipients without active ingredients.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metabolaid®-based nutraceutical formulation
A 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
25 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alicante
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Alejandro Martínez-Rodríguez
Catedrático Ciencias de la Salud
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
European Institute Of Exercise and Health
Elche, Alicante, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UA-2025-05-22_2
Identifier Type: -
Identifier Source: org_study_id