A Phase 3 interventional study of Triticum Aestivum and Placebo (calcined magnesia) in Obesity, Leptin Deficiency and Ghrelin, sponsored by Coordinación de Investigación en Salud, Mexico. Recruiting at 1 site in Mexico. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Coordinación de Investigación en Salud, Mexico · Phase 3, Interventional, and Treatment
Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake, satiety, energy expenditure and weight.
Despite being a highly prevalent disease with major complications, current therapeutic options are not sufficient, as they are not ideal for the entire population. The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality.
Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction, insulin resistance and modulation of neuropeptides involved in food intake.
A double-blind clinical trial is proposed, with two parallel groups, with random assignment and group control. The universe of the sample will be patients with a diagnosis of obesity, residents of the Guadalajara Metropolitan Area, who agree to participate by signing informed consent and can go to the Biomedical Unit 02 of the Mexican Institute of Social Security.
Two parallel groups, with randomization by software using envelopes, will require a total of 38 patients, which will be distributed as follows: 1) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days, and 2) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules of placebo (calcined magnesia) orally every 12 hours for 120 days.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's planned enrollment of 38 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Coordinación de Investigación en Salud, Mexico is the lead sponsor of 95 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People of any sex (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment).
Age from 30 to 50 years old. Residents of the metropolitan area of Guadalajara. Signed informed consent form. People with a diagnosis of obesity (BMI ≥30 - 39.9 kg/m2), stable body weight within the 3 months prior to the start of the study.
Exclusion Criteria:
Diagnosis of diabetes and dyslipidemia. Diagnosis of anxiety and/or depression. History of: liver disease, chronic kidney disease, thyroid disease, cancer. Antidiabetic treatment, lipid-lowering, food supplements, antidepressants, corticosteroids.
Acute infectious processes Alcoholism and/or active smoking in any intensity within the 12 months prior to the start of the study.
Suspected or confirmed pregnancy or breastfeeding. History of drug intake. Recent surgery (\<3 months) Carrying a pacemaker, or any other bioelectronic or metallic element. Excessive sedentary lifestyle defined as physical activity less than the equivalent of 15 minutes of walking per day.
Excessive exercise, defined as physical activity equivalent to running for 60 minutes per day.
Intake of anorexigenic drugs, hypolipidemic drugs or drugs with effect on body weight.
History of any type of cancer, hyperthyroidism, hypothyroidism, renal disease, liver disease and pancreatic disease.
History of hypersensitivity to the study drug (gluten).
A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days.
Drug: Triticum Aestivum
A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of calcined magnesia orally every 12 hours for 120 days.
Drug: Placebo (calcined magnesia)
The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.
The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.
Also known as: Calcined magnesia
To evaluate the effect of Triticum aestivum on leptin in patients with obesity.
To quantify the serum concentrations of leptin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
Time frame: 120 days
To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity.
To quantify the serum concentrations of ghrelin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
Time frame: 120 days
To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity.
To quantify the serum concentrations of adiponectin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
Time frame: 120 days
To evaluate the effect of Triticum aestivum on satiety regulation
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
Time frame: 120 days
To evaluate the effect of Triticum aestivum on appetite regulation
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
Time frame: 120 days
Plan to share: Yes — All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)
Supporting information: Study protocol, Sap
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Coordinación de Investigación en Salud, Mexico