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

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.

Study Overview

• Status: Completed
• Conditions: Emotional Disorder; Weight Loss Trajectory; GLP-1; Microbiota Balance
• Intervention / Treatment: Dietary supplement: Metabolaid®-based nutraceutical formulation; Dietary supplement: Placebo capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • European Institute Of Exercise and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat Mass (%)	To evaluate changes in total fat mass percentage after the 12-week intervention, assessed by bioimpedance analysis (BIODY XPERT ZM).	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lean Mass (%)	To evaluate changes in total lean body mass percentage after the 12-week intervention, measured by bioimpedance analysis.	Baseline and Week 12
Change in Visceral Fat Level	To assess differences in visceral adiposity index obtained from bioimpedance measurements before and after supplementation.	Baseline and Week 12
Change in Body Weight (kg)	To evaluate changes in body weight following the 12-week supplementation period.	Baseline and Week 12
Change in BMI (kg/m²)	To assess changes in body mass index calculated as weight (kg) divided by height squared (m²).	Baseline and Week 12
Change in Waist Circumference (cm)	To measure changes in abdominal circumference as an indicator of central adiposity.	Baseline and Week 12
Change in Hip Circumference (cm)	To record changes in hip circumference to calculate waist-to-hip ratio.	Baseline and Week 12
Change in Gut Microbiota Diversity	To evaluate changes in microbial alpha and beta diversity using 16S rRNA sequencing of stool samples.	Baseline and Week 12
Change in Abundance of Key Gut Microbial Taxa	To analyze specific bacterial taxa abundance associated with metabolic health before and after the intervention.	Baseline and Week 12
Change in Total Energy Intake (kcal/day)	To quantify changes in daily energy consumption from dietary recalls.	Baseline and Week 12
Change in Macronutrient Distribution (%)	To evaluate changes in carbohydrate, protein, and fat intake percentages.	Baseline and Week 12
Change in Fasting Glucose (mg/dL)	To assess changes in fasting blood glucose levels as a metabolic indicator.	Baseline and Week 12
Change in Fasting Insulin (µU/mL)	To measure insulin levels to assess metabolic response to supplementation.	Baseline and Week 12
Change in Total Cholesterol (mg/dL)	To measure total cholesterol concentration in fasting blood samples.	Baseline and Week 12
Change in HDL Cholesterol (mg/dL)	To assess HDL cholesterol changes after supplementation.	Baseline and Week 12
Change in LDL Cholesterol (mg/dL)	To evaluate low-density lipoprotein cholesterol levels before and after intervention.	Baseline and Week 12
Change in Triglycerides (mg/dL)	To determine the impact of supplementation on triglyceride concentrations.	Baseline and Week 12
Change in C-Reactive Protein (mg/L)	To assess systemic inflammation through C-reactive protein levels.	Baseline and Week 12
Change in Interleukin-6 (pg/mL)	To evaluate inflammatory status through IL-6 concentrations	Baseline and Week 12
Change in TNF-alpha (pg/mL)	To measure tumor necrosis factor-alpha as an additional inflammatory marker	Baseline and Week 12
Change in Appetite Score (VAS)	Description: Appetite perception will be evaluated using a Visual Analogue Scale (VAS) consisting of a 100-mm horizontal line, where 0 represents "no appetite at all" and 100 represents "extremely high appetite." Participants will mark their perceived level of appetite on the line, and the score will be measured in millimeters from the left end. Range: 0-100 mm. Interpretation: Higher scores indicate greater appetite perception.	Baseline and Week 12
Change in Satiety Score (VAS)	Description: Perceived fullness or satiety will be evaluated using a Visual Analogue Scale (VAS) consisting of a 100-mm horizontal line, where 0 represents "not at all full" and 100 represents "extremely full." Participants will indicate their perceived level of satiety on the line, and the score will be measured in millimeters from the left end. Range: 0-100 mm. Interpretation: Higher scores indicate greater perceived satiety.	Baseline and Week 12
Change in Physical Activity Level (IPAQ Total Score)	Description: Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which records activity performed over the previous 7 days. The questionnaire includes 7 items covering walking, moderate, and vigorous activities. The total score is expressed in MET-minutes per week and categorized into low, moderate, or high activity levels. Range: 0 to unlimited MET-min/week. Interpretation: Higher scores indicate greater physical activity levels.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: body composition; gut microbiota; polyphenols; prebiotics; nutraceuticals; weight loss maintenance; nutritional supplementation; fat-free mass; GLP-1 receptor agonists; emotional well-being; metabolic recovery; post-weight-loss intervention
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body-Weight Trajectory
• Other Study ID Numbers: UA-2025-05-22_2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No