Overview
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.
Description
Participants who meet the inclusion criteria will be included in the study. They will be randomized into three groups, each receiving a dose of the experimental product: 0mg (placebo), 300mg, or 600mg for 16 weeks. The treatment will be administered as a single daily dose in the morning on an empty stomach.
All participants will undergo the same assessments as the active-treatment groups, including anthropometric measurements, physical activity monitoring, and blood tests to evaluate metabolic and biochemical variables. Participants will be asked to maintain their usual dietary and physical activity habits throughout the study.
Eligibility
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).
