Adiponectin, Ghrelin, Leptin Deficiency, Obesity
Conditions
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.
Interventions
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.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator) All participants will be submitted to the selection of a sealed envelope which will have a numerical code previously defined by a third party for each intervention group. The total number of envelopes required to complete the minimum number of participants will have numerical codes that identify the bottle of intervention treatment that should receive the participant during the intervention period. They will be divided into half blinded codes for triticum aestivum group and half for placebo to complete the size of each subsample. Chance guarantees blinding, neither the participant nor the researcher will know the type of treatment. The database for the blinded statistical analysis will be completed. The blind man will be removed once the statistical analysis has been completed.
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
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of Triticum aestivum on leptin in patients with obesity. | 120 days | To quantify the serum concentrations of leptin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo. |
| To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity. | 120 days | To quantify the serum concentrations of ghrelin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo. |
| To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity. | 120 days | To quantify the serum concentrations of adiponectin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo. |
| To evaluate the effect of Triticum aestivum on satiety regulation | 120 days | To evaluate the effect on satiety by the visual analog scale for satiety and appetite |
| To evaluate the effect of Triticum aestivum on appetite regulation | 120 days | To evaluate the effect on satiety by the visual analog scale for satiety and appetite |
Countries
Mexico
Contacts
Primary ContactSandra O Hernandez Gonzalez, PhD
Outcome results
None listed