Xanthigen and Its Impact on Weight and Metabolic Health

NCT07519980 | Recruiting DMC

• 1 other identifier: UCAMCFE-00039
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Body mass index

  It will be measured at the beginning and at least once during the 4 months of consumption.

• Waist and hip circumference

  It will be measured at the beginning and at least once during the 4 months of consumption.

• Visceral Adiposity Index (VAI)

  From the beginning to 16 weeks

• Fat mass

  It will be measured at the beginning and at least once during the 4 months of consumption.

• Changes in body composition

  From the begynning to 16 weeks

Study Arms (3)

Placebo Control Group

PLACEBO COMPARATOR

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

Xanthigen® 300 mg Group

EXPERIMENTAL

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®

Xanthigen® 600 mg Group

EXPERIMENTAL

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®

Interventions

Control product DIETARY_SUPPLEMENT

They will take one capsule per day.

Placebo Control Group

Experimental group: Xanthigen® DIETARY_SUPPLEMENT

They will take one capsule per day.

Xanthigen® 300 mg Group; Xanthigen® 600 mg Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

UCAM HiTech, Sport & Health Innovation Hub

Murcia, Murcia, 30150, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Francisco Javier López Román, Medical degree

CONTACT

+157 968278157; jlroman@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: April 9, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)