Xanthigen for weight loss and metabolic health in adults with overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, controlled, triple-blind trial assigns eligible adults to one of three parallel groups receiving 0 mg (placebo), 300 mg, or 600 mg Xanthigen once daily for 16 weeks, taken in the morning on an empty stomach. Participants will be asked to maintain their usual diet and physical activity while undergoing scheduled anthropometric measurements, physical activity monitoring, and blood tests to track metabolic and biochemical variables. All groups receive identical visits and assessments to preserve blinding and comparability. The main outcomes are changes in body weight and key metabolic markers over the 16-week period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The subject is able and willing to follow the study protocol procedures to sign the informed consent form prior to the evaluations.
* Participants must be between 20 and 50 years of age at the time of consent.
* The subject is in good physical and mental health as determined by medical history, physical examination, electrocardiogram, vital signs, biochemistry, and hematology results.
* Participants must have a BMI between 27 and 29.9 kg/cm2.
* Desire to lose weight.

Exclusion Criteria:

* Relevant medical history or presence of any medical condition that could interfere with this study, such as a previous diagnosis of diabetes, hypertension, hyperlipidemia, cardiovascular disease, thyroid disease, asthma, arthritis, or inflammatory conditions.
* Fasting blood sugar levels greater than 125 mg/dL and/or total cholesterol levels greater than or equal to 240 mg/dL.
* Blood pressure levels below 90/140 mm Hg (diastolic/systolic).
* Chronic intake of medications/dietary supplements with an impact on body weight or body composition or lipid-modifying products (e.g., protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to selection or during the study.
* Known allergy/sensitivity to any of the components of the investigational product.
* Change in hormonal contraception or any use of hormone replacement therapy (HRT) during or at least 3 months prior to the study (if female).
* Women of childbearing age who are pregnant or intend to become pregnant during the study period.
* Use of any dietary supplements (except mineral supplements, e.g., Ca, Mg).
* Participation in any weight loss intervention or recent change in body weight \> 4.5 kg during the last 9 months.
* History and/or presence of eating disorders such as bulimia, anorexia nervosa, or binge eating, as determined by the investigator.
* Consumption of any dietary supplements (except mineral supplements, e.g., Ca, Mg).
* Participation in any weight loss program or recent change in body weight \> 4.5 kg during the last 9 months.
* History and/or presence of eating disorders such as bulimia, anorexia nervosa, binge eating, as determined by the investigator.
* Individuals who currently participate in aerobic exercise more than 4 times per week, or more than 2.5 hours per week.
* Vegan lifestyle.
* Current smoker or user of nicotine products or cessation of smoking within 1 year of the screening date.
* Gastrointestinal diseases/conditions (colitis ulcers, Crohn's disease, peptic ulcers, celiac disease).

Where it's running

• UCAM HiTech, Sport & Health Innovation Hub
  Murcia, Murcia, Spain Recruiting

Study contacts

• Study coordinator: Francisco Javier López Román, Medical degree
• Email: jlroman@ucam.edu
• Phone: +157 968278157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.