Drug Effect, Insulin Sensitivity, Obesity
Conditions
Brief summary
Obesity is a metabolic disease which has been declared as the most prevalent chronic health problem in adults; according to the World Health Organization (WHO), it is defined as an increase in Body Mass Index (BMI) greater than or equal to 30 kg/m2. In Mexico, according to data from the National Health and Nutrition Survey (ENSANUT) 2018-2019, the prevalence of overweight in adults is 39.1% (36.6% in women, 42.5% in men), of obesity is 36.1% (40.2% in women, 30.5% in men) and of abdominal adiposity 81.6% (88.4% in women and 72.1% in men), with a higher proportion found in the north of the country. In 2010, it was estimated that obesity was the main cause of 3.4 million deaths, the main complications being cardiovascular disease, diabetes mellitus and various types of cancer. The complications of obesity are very varied, mainly presenting changes in the metabolic profile, such as increased blood pressure and abdominal circumference, hypertriglyceridemia and hypercholesterolemia. Another of the main complications derived from obesity is insulin resistance, which is defined as a decreased biological response of peripheral tissues to a specific concentration of insulin with consequent compensatory hyperinsulinemia. The treatment of obesity is based on lifestyle changes (diet and exercise), in addition, there are pharmacological and surgical treatments, however, they are not applicable to the entire population, so despite being a highly prevalent disease with major complications, current therapeutic options are insufficient. Triticum aestivum, better known as wheat grass, is a very common fiber in the diet of the world population, including the Mexican population, in which multiple pre-clinical studies have been reported where the effect of triticum aestivum on the decrease of components of the metabolic profile, such as glycemia, cholesterol, triglycerides and weight, as well as an improvement in insulin sensitivity, has been evidenced; To date, no serious adverse effects related to its consumption have been described, and it can be considered as an effective therapeutic alternative for patients with obesity.
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. A total of 36 patients will be followed, which will be distributed as follows: 1) A group of 18 patients with a diagnosis of obesity without pharmacological or emergency treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days, and 2) A group of 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (calcined magnesia) orally every 12 days for 120 days.
Interventions
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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. 36 patients: 1. 18 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days. 2. 18 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 evaluated.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to communicate and meet all study requirements. * People who sign the consent under written information prior to carrying out any procedure * People of any sex, (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment) Mexicans from 30 to 50 years of age, residents of Guadalajara, Jalisco, beneficiaries of the Instituto Mexicano del Seguro Social (IMSS) * 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, defined as a variability in body weight of less than 5%. * Fasting glucose \<126 mg/dl * Cholesterol \<240 mg/dl * Triglycerides \<300 mg/dl * Resting systolic blood pressure less than 140 mmHg with resting diastolic blood pressure less than 90 mmHg
Exclusion criteria
* Suspected or confirmed pregnancy. * Women breastfeeding or in the postpartum or postpartum period. * History of smoking at any intensity within the 12 months prior to the start of the study. * 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 a day. * Intake of drugs that are anorexigenic, lipid-lowering or have an effect on body weight. * History of any type of cancer, hyperthyroidism, hypothyroidism, kidney disease, liver disease, and pancreatic disease. * History of hypersensitivity to the study drug (gluten) * History of drug intake * Carrying of a pacemaker, or any other permanent bioelectronic element that can modify the electrical bioimpedance reading or can be affected by it. * Patients diagnosed with Morbid Obesity (BMI ≥ 40 kg/m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of Triticum aestivum on Waist Hip Index in patients with obesity | 120 days | Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters) |
| The effect of Triticum aestivum on body weight in patients with obesity | 120 days | Changes in levels of body weight in kilograms. |
| The effect of Triticum aestivum on Body Mass Index in patients with obesity | 120 days | Changes in levels of Body Mass Index (weight in kilograms / (height in meters squared)) |
| The effect of Triticum aestivum on fat percentage in patients with obesity | 120 days | Changes in levels of fat percentage (percentage) |
| The effect of Triticum aestivum on glucose in patients with obesity | 120 days | Changes in levels of glucose in mg/dl. |
| The effect of Triticum aestivum on insulin sensitivity in patients with obesity | 120 days | Changes in levels of insulin sensitivity in the triglyceride and glucose index (natural logarithm ((glucose in mg/dl \* triglycerides in mg/dl)/2)) |
| The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity | 120 days | Changes in levels of high-density lipoprotein in mg/dl. |
| The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity | 120 days | Changes in levels of low-density lipoprotein cholesterol in mg/dl. |
| The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity | 120 days | Changes in levels of very low-density lipoprotein cholesterol in mg/dl. |
| The effect of Triticum aestivum on total cholesterol in patients with obesity | 120 days | Changes in levels of total cholesterol in mg/dl. |
| The effect of Triticum aestivum on triglycerides in patients with obesity | 120 days | Changes in levels of triglycerides in mg/dl. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of Triticum aestivum on renal profile in patients with obesity | 120 days | Changes in levels of creatinine in mg/dl. |
| The effect of Triticum aestivum on hepatic profile in patients with obesity | 120 days | Changes in levels of Alanine aminotransferase in mg/dl and Aspartate aminotransferase in mg/dl |
| The effect of Triticum aestivum on blood pressure in patients with obesity | 120 days | Changes in levels of blood pressure in mmHg. |
Countries
Mexico
Contacts
Primary ContactSandra O Hernández González, PhD
Backup ContactMaría C Espinel Bermúdez, PhD
Outcome results
None listed