Evaluation of a Nutritional Intervention With Dietary Supplements in People Who Have Recently Lost Weight: Effects on Body Composition, Emotional Health, and Gut Microbiota
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alicante
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in Fat Mass (%)
Overview
Brief 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:
- Experimental Group: Daily intake of a multi-component dietary supplement containing polyphenols, prebiotic fibers, and natural extracts with antioxidant and anti-inflammatory properties.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Fat Mass (%)
Time Frame: Baseline and Week 12
To evaluate changes in total fat mass percentage after the 12-week intervention, assessed by bioimpedance analysis (BIODY XPERT ZM).
Secondary Outcomes
- Change in Lean Mass (%)(Baseline and Week 12)
- Change in Visceral Fat Level(Baseline and Week 12)
- Change in Body Weight (kg)(Baseline and Week 12)
- Change in BMI (kg/m²)(Baseline and Week 12)
- Change in Waist Circumference (cm)(Baseline and Week 12)
- Change in Hip Circumference (cm)(Baseline and Week 12)
- Change in Gut Microbiota Diversity(Baseline and Week 12)
- Change in Abundance of Key Gut Microbial Taxa(Baseline and Week 12)
- Change in Appetite Score (VAS)(Baseline and Week 12)
- Change in Satiety Score (VAS)(Baseline and Week 12)
- Change in Physical Activity Level (IPAQ Total Score)(Baseline and Week 12)
- Change in Total Energy Intake (kcal/day)(Baseline and Week 12)
- Change in Macronutrient Distribution (%)(Baseline and Week 12)
- Change in Fasting Glucose (mg/dL)(Baseline and Week 12)
- Change in Fasting Insulin (µU/mL)(Baseline and Week 12)
- Change in Total Cholesterol (mg/dL)(Baseline and Week 12)
- Change in HDL Cholesterol (mg/dL)(Baseline and Week 12)
- Change in LDL Cholesterol (mg/dL)(Baseline and Week 12)
- Change in Triglycerides (mg/dL)(Baseline and Week 12)
- Change in C-Reactive Protein (mg/L)(Baseline and Week 12)
- Change in Interleukin-6 (pg/mL)(Baseline and Week 12)
- Change in TNF-alpha (pg/mL)(Baseline and Week 12)
Investigators
Prof. Dr. Alejandro Martínez-Rodríguez
Catedrático Ciencias de la Salud
University of Alicante