Clinical trial NCT06501248: Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
Official title: Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Drug Effect
Insulin Sensitivity
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2024-07-15
Enrollment: 36
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.

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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The effect of Triticum aestivum on glucose in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on insulin sensitivity in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on total cholesterol in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on triglycerides in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on body weight in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on Body Mass Index in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on fat percentage in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on Waist Hip Index in patients with obesity
timeFrame: 120 days
Secondary outcomes:
measure: The effect of Triticum aestivum on blood pressure in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on renal profile in patients with obesity
timeFrame: 120 days
measure: The effect of Triticum aestivum on hepatic profile in patients with obesity
timeFrame: 120 days
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 Hernández González, PhD
role: PRINCIPAL_INVESTIGATOR
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