Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity

Coordinación de Investigación en Salud, Mexico

Status and phase: Enrolling; Phase 3

Conditions: Ghrelin; Obesity; Adiponectin; Leptin Deficiency

Treatments: Drug: Placebo (calcined magnesia); Drug: Triticum Aestivum

Study type: Interventional

Funder types: Other

Identifiers

NCT06496100

R-2023-1301-251

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Triticum aestivum

Active Comparator group

Description:

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.

Treatment:

Drug: Triticum Aestivum

Placebo (calcined magnesia)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (calcined magnesia)