Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Triticum aestivum
A group of 18 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.
干预措施: Triticum Aestivum (Drug)
Placebo (calcined magnesia)
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 hours for 120 days.
干预措施: Placebo (calcined magnesia) (Drug)
结局指标
主要结局
The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity
时间窗: 120 days
Changes in levels of low-density lipoprotein cholesterol in mg/dl.
The effect of Triticum aestivum on glucose in patients with obesity
时间窗: 120 days
Changes in levels of glucose in mg/dl.
The effect of Triticum aestivum on insulin sensitivity in patients with obesity
时间窗: 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 triglycerides in patients with obesity
时间窗: 120 days
Changes in levels of triglycerides in mg/dl.
The effect of Triticum aestivum on fat percentage in patients with obesity
时间窗: 120 days
Changes in levels of fat percentage (percentage)
The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity
时间窗: 120 days
Changes in levels of high-density lipoprotein in mg/dl.
The effect of Triticum aestivum on total cholesterol in patients with obesity
时间窗: 120 days
Changes in levels of total cholesterol in mg/dl.
The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity
时间窗: 120 days
Changes in levels of very low-density lipoprotein cholesterol in mg/dl.
The effect of Triticum aestivum on body weight in patients with obesity
时间窗: 120 days
Changes in levels of body weight in kilograms.
The effect of Triticum aestivum on Body Mass Index in patients with obesity
时间窗: 120 days
Changes in levels of Body Mass Index (weight in kilograms / (height in meters squared))
The effect of Triticum aestivum on Waist Hip Index in patients with obesity
时间窗: 120 days
Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters)
次要结局
- The effect of Triticum aestivum on hepatic profile in patients with obesity(120 days)
- The effect of Triticum aestivum on renal profile in patients with obesity(120 days)
- The effect of Triticum aestivum on blood pressure in patients with obesity(120 days)