Xanthigen and Its Impact on Weight and Metabolic Health
Recruiting · NCT07519980 · Interventional (participants receive a specific treatment) · Lead sponsor: Universidad Católica San Antonio de Murcia
View the official record on ClinicalTrials.gov →Interventions studied
Control productExperimental group: Xanthigen®
What this trial is about
Randomized, controlled, triple-blind clinical trial with three parallel arms based on the product consumed (low-dose experimental product, high-dose experimental product, and placebo product) and conducted at a single center to measure the efficacy of a product (Xanthigen®) on overweight or obesity during 16 weeks of consumption.
Who can take part
Age range
20 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- UCAM HiTech, Sport & Health Innovation Hub - Murcia, Murcia, Spain