Obesity & OverweightXANNCT07519980
Xanthigen and Its Impact on Weight and Metabolic Health
A study testing Experimental group: Xanthigen® in people with Obesity & Overweight, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Experimental group: Xanthigen®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
UCAM HiTech, Sport & Health Innovation Hub
Murcia, Murcia, 30150
About this study
Official title: 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.
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.
- Conditions
- Obesity & Overweight
- Being tested
- Experimental group: Xanthigen®, Control product
- Keywords
- Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group: Xanthigen®Dietary supplement
They will take one capsule per day.
Control productDietary supplement
They will take one capsule per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Experimental group: Xanthigen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be measured at the beginning and at least once during the 4 months of consumption.
Secondary outcomes (20)
Body mass index
It is calculated by dividing weight in kilograms by the square of height in meters.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: It will be evaluated from the start until 16 weeks of consumption.
Adverse events
It will be evaluated at each of the visits.
Measured: At 16 weeks after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start2 Feb 2026
- Primary completion20 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519980
- Sponsor's protocol ID
- UCAMCFE-00039
- Acronym
- XAN
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xanthigen on Weight Control and Metabolic Variables in Overweight Individuals
- ClinicalTrials.gov ID
- NCT07519980
- Acronym / sponsor ID
- XAN / UCAMCFE-00039
- Conditions
- Obesity & Overweight
- Keywords
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Control Group | Placebo comparator | Dietary Supplement: Control productParticipants 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. |
| Xanthigen® 300 mg Group | Experimental | Dietary Supplement: Experimental group: Xanthigen®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. |
| Xanthigen® 600 mg Group | Experimental | Dietary Supplement: Experimental group: Xanthigen®Participants in this arm will receive 600 mg of Xanthigen®, administered once daily in the morning on an empty stomach. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group: Xanthigen®They will take one capsule per day. | Dietary supplement | Xanthigen® 300 mg Group, Xanthigen® 600 mg Group |
| Control productThey will take one capsule per day. | Dietary supplement | Placebo Control Group |
Primary outcome
Weight
Time frame: It will be measured at the beginning and at least once during the 4 months of consumption.
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.
20 secondary outcomes
Body mass index
Time frame: It will be measured at the beginning and at least once during the 4 months of consumption.
Waist and hip circumference
Time frame: It will be measured at the beginning and at least once during the 4 months of consumption.
Visceral Adiposity Index (VAI)
Time frame: From the beginning to 16 weeks
Fat mass
Time frame: It will be measured at the beginning and at least once during the 4 months of consumption.
Changes in body composition
Time frame: From the begynning to 16 weeks
Resting energy expenditure (REE)
Time frame: From the beginning to 16 weeks
Blood pressure
Time frame: It will be evaluated from the start until 16 weeks of consumption.
Serum lipid profile
Time frame: From the begynning to 16 weeks
Effect on glucose metabolism
Time frame: From the begynning to 16 weeks
Plasma ghrelin concentration
Time frame: It will be measured at the beginning and after 4 months of consumption.
Plasma leptin concentration
Time frame: It will be measured at the beginning and after 4 months of consumption.
Plasma adiponectin concentration
Time frame: It will be measured at the beginning and after 4 months of consumption.
Superoxide dismutase (SOD)
Time frame: It will be measured at the beginning and after 4 months of consumption.
Serum metabolomic profile via metabolite analysis
Time frame: At 16 weeks after consumption
Psycological General Wellbeing Index (PGWBI)
Time frame: It will be measured at the beginning, after two months, and after four months of consumption.
Three factor eating questionnaire (TFEQ)
Time frame: It will be measured at the beginning, after two months, and after four months of consumption.
24-hour dietary record
Time frame: It will be measured at the beginning and after 4 months of consumption.
Physical Exercise Monitoring
Time frame: It will be measured at the beginning and after 4 months of consumption.
Liver safety variables
Time frame: It will be evaluated from the start until 16 weeks of consumption.
Adverse events
Time frame: At 16 weeks after consumption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group: Xanthigen® in people with Obesity & Overweight, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier López Román, Medical degree (+157 968278157, jlroman@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: It will be measured at the beginning and at least once during the 4 months of consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.