Xanthigen and Its Impact on Weight and Metabolic Health (XAN)

Effects of Xanthigen on Weight Control and Metabolic Variables in Overweight Individuals

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Dietary supplement: Control product; Dietary supplement: Experimental group: Xanthigen®

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Spain
  • Murcia
    • Murcia, Murcia, Spain, 30150
      • Recruiting
      • UCAM HiTech, Sport & Health Innovation Hub

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control Group; Participants in this arm will receive a placebo identical in appearance and administration schedule to the active product. The treatment will be administered once daily in the morning on an empty stomach.	Dietary supplement: Control product; They will take one capsule per day.
Experimental: Xanthigen® 300 mg Group; Participants assigned to this arm will receive 300 mg of Xanthigen®, administered once daily in the morning on an empty stomach according to the study protocol.	Dietary supplement: Experimental group: Xanthigen®; They will take one capsule per day.
Experimental: Xanthigen® 600 mg Group; Participants in this arm will receive 600 mg of Xanthigen®, administered once daily in the morning on an empty stomach.	Dietary supplement: Experimental group: Xanthigen®; They will take one capsule per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Evaluate the effects of chronic supplementation with two doses (600 and 300mg) of Xanthigen® on weight loss. Body weight refers to the measurement of a person's total mass in kilograms. It is a basic variable that indicates the amount of mass a person has in their body. It will be assessed using the TANITA.	It will be measured at the beginning and at least once during the 4 months of consumption.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	It is calculated by dividing weight in kilograms by the square of height in meters.	It will be measured at the beginning and at least once during the 4 months of consumption.
Waist and hip circumference	Waist circumference refers to the measurement around the narrowest part of the abdominal area, and hip circumference is measured around the most prominent region of the buttocks	It will be measured at the beginning and at least once during the 4 months of consumption.
Visceral Adiposity Index (VAI)	The VAI is an index that combines waist circumference, hip circumference, body mass index, and blood triglyceride levels. It provides an estimate of visceral adiposity, which is the fat stored around the internal organs in the abdominal cavity.	From the beginning to 16 weeks
Fat mass	It will be measured using dual-energy X-ray absorptiometry (DEXA), which provides an accurate estimate of body composition.	It will be measured at the beginning and at least once during the 4 months of consumption.
Changes in body composition	Determine variations in body composition (lean mass and fat mass).	From the begynning to 16 weeks
Resting energy expenditure (REE)	Analyze the effect of Xanthigen® supplementation on resting energy expenditure (REE) and its possible significant increase after the intervention.	From the beginning to 16 weeks
Blood pressure	It is measured in millimeters of mercury (mm Hg) and recorded as two values: systolic pressure (the pressure when the heart contracts) and diastolic pressure (the pressure when the heart is at rest between beats).	It will be evaluated from the start until 16 weeks of consumption.
Serum lipid profile	Assess the effect of the supplement on the lipid profile (total cholesterol, triglycerides, LDL, and HDL).	From the begynning to 16 weeks
Effect on glucose metabolism	Analyze the effect of the intervention on glucose metabolism, including fasting glucose and insulin levels and glycosylated hemoglobin (HbA1c).	From the begynning to 16 weeks
Plasma ghrelin concentration	Known as the "hunger hormone." It will be evaluated through a blood sample. The unit of measurement will be pg/mL	It will be measured at the beginning and after 4 months of consumption.
Plasma leptin concentration	Called the "satiety hormone." It will be evaluated through a blood sample. The unit of measurement will be ng/mL	It will be measured at the beginning and after 4 months of consumption.
Plasma adiponectin concentration	A hormone also produced by adipose tissue, but with effects opposite to what one would expect from an adipokine. It will be evaluated through a blood sample. The unit of measurement will be µg/mL	It will be measured at the beginning and after 4 months of consumption.
Superoxide dismutase (SOD)	Superoxide dismutase is an antioxidant enzyme that helps protect cells from oxidative damage. SOD levels can be used to assess oxidative stress in the body.	It will be measured at the beginning and after 4 months of consumption.
Serum metabolomic profile via metabolite analysis	A comprehensive and systematic study of the metabolites present in a serum sample will be conducted.	At 16 weeks after consumption
Psycological General Wellbeing Index (PGWBI)	The PGWBI is a measure of subjective psychological well-being. It assesses self-representations of intrapersonal affective or emotional states that reflect a sense of subjective well-being or ill-being and thus captures what we might call a subjective perception of well-being. It has a range of 0-110; higher scores indicate greater well-being	It will be measured at the beginning, after two months, and after four months of consumption.
Three factor eating questionnaire (TFEQ)	The TFEQ is a tool for assessing eating behavior. It measures three dimensions of human eating behavior: cognitive restriction of eating, disinhibition, and hunger. Cognitive restriction, disinhibition, and hunger; range varies by subscale; higher scores indicate a greater presence of the behavior	It will be measured at the beginning, after two months, and after four months of consumption.
24-hour dietary record	A 24-hour food record will be conducted to determine changes in participants' food intake. Estimated kcal/day will be recorded.	It will be measured at the beginning and after 4 months of consumption.
Physical Exercise Monitoring	The METs performed by the subjects will be evaluated to determine that there are no changes in the physical exercise performed.	It will be measured at the beginning and after 4 months of consumption.
Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L).	It will be evaluated from the start until 16 weeks of consumption.
Adverse events	It will be evaluated at each of the visits.	At 16 weeks after consumption

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Overweight
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: UCAMCFE-00039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No