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

University of Alicante

Status: Completed

Conditions: Emotional Disorder; Microbiota Balance; GLP-1; Weight Loss Trajectory

Treatments: Dietary Supplement: Metabolaid®-based nutraceutical formulation; Dietary Supplement: Placebo capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT07269821

UA-2025-05-22_2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Arm 1: Experimental - Dietary supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Metabolaid®-based nutraceutical formulation

Arm 2: Placebo - Control

Placebo Comparator group

Description:

Participants will receive a placebo identical in appearance, taste, and packaging to the active supplement. The placebo capsules contain inert excipients without active ingredients.

Treatment:

Dietary Supplement: Placebo capsules