Obesity & Overweight
Conditions
Keywords
Obesity, Overweight
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTExperimental group: Xanthigen®
They will take one capsule per day.
DIETARY_SUPPLEMENTControl product
They will take one capsule per day.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
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 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). * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | 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. |
| Waist and hip circumference | 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 |
| Visceral Adiposity Index (VAI) | 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. |
| Fat mass | 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. |
| Changes in body composition | From the begynning to 16 weeks | Determine variations in body composition (lean mass and fat mass). |
| Resting energy expenditure (REE) | 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. |
| Blood pressure | 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). |
| Serum lipid profile | From the begynning to 16 weeks | Assess the effect of the supplement on the lipid profile (total cholesterol, triglycerides, LDL, and HDL). |
| Effect on glucose metabolism | 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). |
| Plasma ghrelin concentration | 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 |
| Plasma leptin concentration | 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 |
| Plasma adiponectin concentration | 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 |
| Superoxide dismutase (SOD) | 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. |
| Serum metabolomic profile via metabolite analysis | At 16 weeks after consumption | A comprehensive and systematic study of the metabolites present in a serum sample will be conducted. |
| Psycological General Wellbeing Index (PGWBI) | 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 |
| Three factor eating questionnaire (TFEQ) | 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 |
| 24-hour dietary record | 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. |
| Physical Exercise Monitoring | 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. |
| Liver safety variables | 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). |
| Adverse events | At 16 weeks after consumption | It will be evaluated at each of the visits. |
Countries
Spain
Contacts
CONTACTFrancisco Javier López Román, Medical degree
Outcome results
None listed