UCAM HiTech, Sport & Health Innovation Hub
Murcia, 30150, Spain
Location status: Recruiting
NCT Number: NCT07519980
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.
Interested in participating?
Request Info20 year–50 year
All sexes
Interventional
Not applicable
Murcia, 30150, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
They will take one capsule per day.
They will take one capsule per day.
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.
Time frame: It will be measured at the beginning and at least once during the 4 months of consumption.
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.
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: From the beginning to 16 weeks
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: It will be measured at the beginning and at least once during the 4 months of consumption.
It will be measured using dual-energy X-ray absorptiometry (DEXA), which provides an accurate estimate of body composition.
Time frame: From the begynning to 16 weeks
Determine variations in body composition (lean mass and fat mass).
Time frame: From the beginning to 16 weeks
Analyze the effect of Xanthigen® supplementation on resting energy expenditure (REE) and its possible significant increase after the intervention.
Time frame: It will be evaluated from the start until 16 weeks of consumption.
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: From the begynning to 16 weeks
Assess the effect of the supplement on the lipid profile (total cholesterol, triglycerides, LDL, and HDL).
Time frame: From the begynning to 16 weeks
Analyze the effect of the intervention on glucose metabolism, including fasting glucose and insulin levels and glycosylated hemoglobin (HbA1c).
Time frame: It will be measured at the beginning and after 4 months of consumption.
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.
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.
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.
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: At 16 weeks after consumption
A comprehensive and systematic study of the metabolites present in a serum sample will be conducted.
Time frame: It will be measured at the beginning, after two months, and after four months of consumption.
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.
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 and after 4 months of consumption.
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.
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 evaluated from the start until 16 weeks of consumption.
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: At 16 weeks after consumption
It will be evaluated at each of the visits.
Contact information is provided by the study sponsor or research team.
Universidad Católica San Antonio de Murcia
Other
Effects of Xanthigen on Weight Control and Metabolic Variables in Overweight Individuals
Acronym: XAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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