Xanthigen and Its Impact on Weight and Metabolic Health
ConditionObesity & Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorUniversidad Católica San Antonio de Murcia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental group: Xanthigen®
Dietary supplementThey will take one capsule per day.
Control product
Dietary supplementThey will take one capsule per day.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Placebo Control GroupPlacebo comparator 1 intervention
Group B: Xanthigen® 300 mg GroupExperimental treatment 1 intervention
Group C: Xanthigen® 600 mg GroupExperimental treatment 1 intervention
Trial outcomes
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 weeks4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov