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 | Completed

• 1 other identifier: UA-2025-05-22_2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

weight loss maintenance; GLP-1 receptor agonists; body composition; fat-free mass; nutritional supplementation; polyphenols; prebiotics; gut microbiota; emotional well-being; metabolic recovery; post-weight-loss intervention; nutraceuticals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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

Study Arms (2)

Arm 1: Experimental - Dietary supplement

EXPERIMENTAL

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

Arm 2: Placebo - Control

PLACEBO COMPARATOR

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

Interventions

Metabolaid®-based nutraceutical formulation DIETARY_SUPPLEMENT

A 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss.

Arm 1: Experimental - Dietary supplement

Placebo capsules DIETARY_SUPPLEMENT

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.

Arm 2: Placebo - Control

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

European Institute Of Exercise and Health

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Body-Weight Trajectory

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Catedrático Ciencias de la Salud

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

ES (1)