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RecruitingNCT07519980XANUpdated May 7, 2026

Xanthigen and Its Impact on Weight and Metabolic Health

An interventional study of Experimental group: Xanthigen® and Control product in Obesity & Overweight, sponsored by Universidad Católica San Antonio de Murcia. Recruiting at 1 site in Spain. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity & Overweight

Keywords

  • Obesity
  • Overweight
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 180 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The subject is able and willing to follow the study protocol procedures to sign the 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, , vital signs, biochemistry, and hematology results.
  • Participants must have a between 27 and 29.9 kg/cm2.
  • Desire to lose weight.

Exclusion criteria

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 product.
  • Change in hormonal 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).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • 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

  • 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®

  • 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®

Interventions

  • Dietary supplementExperimental group: Xanthigen®

    They will take one capsule per day.

  • Dietary supplementControl product

    They will take one capsule per day.

06

What researchers measure

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.

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

Secondary outcomes

  1. Body mass index

    It is calculated by dividing weight in kilograms by the square of height in meters.

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

  2. 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

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

  3. 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.

    Time frame: From the beginning to 16 weeks

  4. Fat mass

    It will be measured using dual-energy X-ray absorptiometry (DEXA), which provides an accurate estimate of body composition.

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

  5. Changes in body composition

    Determine variations in body composition (lean mass and fat mass).

    Time frame: From the begynning to 16 weeks

  6. Resting energy expenditure (REE)

    Analyze the effect of Xanthigen® supplementation on resting energy expenditure (REE) and its possible significant increase after the intervention.

    Time frame: From the beginning to 16 weeks

  7. 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).

    Time frame: It will be evaluated from the start until 16 weeks of consumption.

  8. Serum lipid profile

    Assess the effect of the supplement on the lipid profile (total cholesterol, triglycerides, LDL, and HDL).

    Time frame: From the begynning to 16 weeks

  9. Effect on glucose metabolism

    Analyze the effect of the intervention on glucose metabolism, including fasting glucose and insulin levels and glycosylated hemoglobin (HbA1c).

    Time frame: From the begynning to 16 weeks

  10. Plasma ghrelin concentration

    Known as the "hunger hormone." It will be evaluated through a blood sample. The unit of measurement will be pg/mL

    Time frame: It will be measured at the beginning and after 4 months of consumption.

  11. Plasma leptin concentration

    Called the "satiety hormone." It will be evaluated through a blood sample. The unit of measurement will be ng/mL

    Time frame: It will be measured at the beginning and after 4 months of consumption.

  12. 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

    Time frame: It will be measured at the beginning and after 4 months of consumption.

  13. 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.

    Time frame: It will be measured at the beginning and after 4 months of consumption.

  14. Serum metabolomic profile via metabolite analysis

    A comprehensive and systematic study of the metabolites present in a serum sample will be conducted.

    Time frame: At 16 weeks after consumption

  15. 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

    Time frame: It will be measured at the beginning, after two months, and after four months of consumption.

  16. 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

    Time frame: It will be measured at the beginning, after two months, and after four months of consumption.

  17. 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.

    Time frame: It will be measured at the beginning and after 4 months of consumption.

  18. Physical Exercise Monitoring

    The METs performed by the subjects will be evaluated to determine that there are no changes in the physical exercise performed.

    Time frame: It will be measured at the beginning and after 4 months of consumption.

  19. 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).

    Time frame: It will be evaluated from the start until 16 weeks of consumption.

  20. Adverse events

    It will be evaluated at each of the visits.

    Time frame: At 16 weeks after consumption

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07519980
Responsible party
Francisco Javier López Román (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Apr 9, 2026
Start date
Feb 2, 2026
Primary completion
Jul 20, 2026 (estimated)
Completion
Sep 15, 2026 (estimated)
Last update
May 7, 2026

Study contacts

Francisco Javier López Román, Medical degree
Contact
jlroman@ucam.edu
+157 968278157

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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