GLP-1NCT07269821
Evaluation of a Nutritional Intervention With Dietary Supplements in People Who Have Recently Lost Weight: Effects on Body Composition, Emotional Health, and Gut Microbiota
A study testing Metabolaid®-based nutraceutical formulation in people with GLP-1 and Weight Loss Trajectory, run by University of Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- GLP-1, Weight Loss Trajectory, Emotional Disorder
- What is being tested?
- Metabolaid®-based nutraceutical formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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 and antioxidants) and a placebo group. Both groups will maintain their habitual diet and lifestyle throughout the study.
Read more
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.
Read the 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 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.
- Conditions
- GLP-1, Weight Loss Trajectory, Emotional Disorder, Microbiota Balance
- Being tested
- Metabolaid®-based nutraceutical formulation, Placebo capsules
- Keywords
- weight loss maintenance, GLP-1 receptor agonists, body composition, fat-free mass, nutritional supplementation, polyphenols, gut microbiota, emotional well-being, metabolic recovery, post-weight-loss intervention, nutraceuticals
- Medical subject headings
- Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolaid®-based nutraceutical formulationDietary supplement
A 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss.
Placebo capsulesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Mass (%)
To evaluate changes in total fat mass percentage after the 12-week intervention, assessed by bioimpedance analysis (BIODY XPERT ZM).
Measured: Baseline and Week 12
Secondary outcomes (22)
Change in Lean Mass (%)
To evaluate changes in total lean body mass percentage after the 12-week intervention, measured by bioimpedance analysis.
Measured: Baseline and Week 12
Change in Visceral Fat Level
To assess differences in visceral adiposity index obtained from bioimpedance measurements before and after supplementation.
Measured: Baseline and Week 12
Change in Body Weight (kg)
To evaluate changes in body weight following the 12-week supplementation period.
Measured: 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).
Measured: Baseline and Week 12
Change in Waist Circumference (cm)
To measure changes in abdominal circumference as an indicator of central adiposity.
Measured: Baseline and Week 12
Change in Hip Circumference (cm)
To record changes in hip circumference to calculate waist-to-hip ratio.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Change in Total Energy Intake (kcal/day)
To quantify changes in daily energy consumption from dietary recalls.
Measured: Baseline and Week 12
Change in Macronutrient Distribution (%)
To evaluate changes in carbohydrate, protein, and fat intake percentages.
Measured: Baseline and Week 12
Change in Fasting Glucose (mg/dL)
To assess changes in fasting blood glucose levels as a metabolic indicator.
Measured: Baseline and Week 12
Change in Fasting Insulin (µU/mL)
To measure insulin levels to assess metabolic response to supplementation.
Measured: Baseline and Week 12
Change in Total Cholesterol (mg/dL)
To measure total cholesterol concentration in fasting blood samples.
Measured: Baseline and Week 12
Change in HDL Cholesterol (mg/dL)
To assess HDL cholesterol changes after supplementation.
Measured: Baseline and Week 12
Change in LDL Cholesterol (mg/dL)
To evaluate low-density lipoprotein cholesterol levels before and after intervention.
Measured: Baseline and Week 12
Change in Triglycerides (mg/dL)
To determine the impact of supplementation on triglyceride concentrations.
Measured: Baseline and Week 12
Change in C-Reactive Protein (mg/L)
To assess systemic inflammation through C-reactive protein levels.
Measured: Baseline and Week 12
Change in Interleukin-6 (pg/mL)
To evaluate inflammatory status through IL-6 concentrations
Measured: Baseline and Week 12
Change in TNF-alpha (pg/mL)
To measure tumor necrosis factor-alpha as an additional inflammatory marker
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jul 2025
- Primary completion31 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269821
- Sponsor's protocol ID
- UA-2025-05-22_2
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nutritional Intervention With Dietary Supplements in People Who Have Recently Lost Weight: Effects on Body Composition, Emotional Health, and Gut Microbiota
- ClinicalTrials.gov ID
- NCT07269821
- Acronym / sponsor ID
- UA-2025-05-22_2
- 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, gut microbiota, emotional well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Experimental - Dietary supplement | Experimental | Dietary Supplement: Metabolaid®-based nutraceutical formulationParticipants 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. |
| Arm 2: Placebo - Control | Placebo comparator | Dietary Supplement: Placebo capsulesParticipants will receive a placebo identical in appearance, taste, and packaging to the active supplement. The placebo capsules contain inert excipients without active ingredients. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolaid®-based nutraceutical formulationA 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss. | Dietary supplement | Arm 1: Experimental - Dietary supplement |
| Placebo capsulesA 12-week placebo supplementation with capsules identical in appearance to the experimental product, to evaluate differences in body composition, gut microbiota, and emotional parameters. | Dietary supplement | Arm 2: Placebo - Control |
Primary outcome
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).
22 secondary outcomes
Change in Lean Mass (%)
Time frame: Baseline and Week 12
Change in Visceral Fat Level
Time frame: Baseline and Week 12
Change in Body Weight (kg)
Time frame: Baseline and Week 12
Change in BMI (kg/m²)
Time frame: Baseline and Week 12
Change in Waist Circumference (cm)
Time frame: Baseline and Week 12
Change in Hip Circumference (cm)
Time frame: Baseline and Week 12
Change in Gut Microbiota Diversity
Time frame: Baseline and Week 12
Change in Abundance of Key Gut Microbial Taxa
Time frame: Baseline and Week 12
Change in Appetite Score (VAS)
Time frame: Baseline and Week 12
Change in Satiety Score (VAS)
Time frame: Baseline and Week 12
Change in Physical Activity Level (IPAQ Total Score)
Time frame: Baseline and Week 12
Change in Total Energy Intake (kcal/day)
Time frame: Baseline and Week 12
Change in Macronutrient Distribution (%)
Time frame: Baseline and Week 12
Change in Fasting Glucose (mg/dL)
Time frame: Baseline and Week 12
Change in Fasting Insulin (µU/mL)
Time frame: Baseline and Week 12
Change in Total Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Change in HDL Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Change in LDL Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Change in Triglycerides (mg/dL)
Time frame: Baseline and Week 12
Change in C-Reactive Protein (mg/L)
Time frame: Baseline and Week 12
Change in Interleukin-6 (pg/mL)
Time frame: Baseline and Week 12
Change in TNF-alpha (pg/mL)
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolaid®-based nutraceutical formulation in people with GLP-1 and Weight Loss Trajectory, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat Mass (%) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.