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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group: Xanthigen® | Dietary Supplement | They will take one capsule per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | It is calculated by dividing weight in kilograms by the square of height in meters. | It will be measured at the beginning and at least once during the 4 months of consumption. |
| Waist and hip circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Javier López Román, Medical degree | Contact | +157 968278157 | jlroman@ucam.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM HiTech, Sport & Health Innovation Hub | Recruiting | Murcia | Murcia | 30150 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control product | Dietary Supplement | They will take one capsule per day. |
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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
| 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. | 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. | 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). | 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. | 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). | 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). | 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). | 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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. | 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. | 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). | It will be evaluated from the start until 16 weeks of consumption. |
| Adverse events | It will be evaluated at each of the visits. | At 16 weeks after consumption |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |