Clinical trial NCT06496100: Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
Official title: Effect of Triticum Aestivum on Appetite Regulation and the Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Leptin Deficiency
Ghrelin
Adiponectin
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2024-07-11
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled clinical trial, of two parallel groups, double blind, with random assignment and control group.

38 patients:

1. 19 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days.
2. 19 patients with 500 mg of placebo orally every 12 hours for 120 days.

   * Visit 1/ Day -7: Screening period, information about the study, signing of informed consent, medical history, anthropometric measurements, baseline laboratory tests.
   * Visit 2/Day 0: Randomization, 60 tablets of Triticum aestivum or placebo will be given, general diet and exercise recommendations.
   * Visit 3,4,5/Day 30,60,90: Treatment adherence evaluation, laboratory tests, adverse events evaluation, general diet and exercise recommendations and 60 tablets of Triticum aestivum or placebo will be given.
   * Visit 6/Final/Day 120 ÷ 7: Anthropometric measurements will be taken, laboratory tests will be performed, adherence to treatment and adverse events will be
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: To evaluate the effect of Triticum aestivum on leptin in patients with obesity.
timeFrame: 120 days
measure: To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity.
timeFrame: 120 days
measure: To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity.
timeFrame: 120 days
measure: To evaluate the effect of Triticum aestivum on satiety regulation
timeFrame: 120 days
measure: To evaluate the effect of Triticum aestivum on appetite regulation
timeFrame: 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
name: Sandra O Hernandez Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References: