Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity

July 8, 2024 updated by: Coordinación de Investigación en Salud, Mexico

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44380
        • Recruiting
        • Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
        • Contact:
        • Principal Investigator:
          • Sandra O Hernández González, PhD
        • Contact:
        • Sub-Investigator:
          • María C Espinel Bermúdez, PhD
        • Sub-Investigator:
          • Emmanuel A Flores Hernández, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Triticum Aestivum
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
Placebo Comparator: 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.
Drug: Placebo (calcined magnesia)
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
Other Names:
  • Calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of Triticum aestivum on glucose in patients with obesity
Time Frame: 120 days
Changes in levels of glucose in mg/dl.
120 days
The effect of Triticum aestivum on insulin sensitivity in patients with obesity
Time Frame: 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))
120 days
The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity
Time Frame: 120 days
Changes in levels of high-density lipoprotein in mg/dl.
120 days
The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity
Time Frame: 120 days
Changes in levels of low-density lipoprotein cholesterol in mg/dl.
120 days
The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity
Time Frame: 120 days
Changes in levels of very low-density lipoprotein cholesterol in mg/dl.
120 days
The effect of Triticum aestivum on total cholesterol in patients with obesity
Time Frame: 120 days
Changes in levels of total cholesterol in mg/dl.
120 days
The effect of Triticum aestivum on triglycerides in patients with obesity
Time Frame: 120 days
Changes in levels of triglycerides in mg/dl.
120 days
The effect of Triticum aestivum on body weight in patients with obesity
Time Frame: 120 days
Changes in levels of body weight in kilograms.
120 days
The effect of Triticum aestivum on Body Mass Index in patients with obesity
Time Frame: 120 days
Changes in levels of Body Mass Index (weight in kilograms / (height in meters squared))
120 days
The effect of Triticum aestivum on fat percentage in patients with obesity
Time Frame: 120 days
Changes in levels of fat percentage (percentage)
120 days
The effect of Triticum aestivum on Waist Hip Index in patients with obesity
Time Frame: 120 days
Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters)
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of Triticum aestivum on blood pressure in patients with obesity
Time Frame: 120 days
Changes in levels of blood pressure in mmHg.
120 days
The effect of Triticum aestivum on renal profile in patients with obesity
Time Frame: 120 days
Changes in levels of creatinine in mg/dl.
120 days
The effect of Triticum aestivum on hepatic profile in patients with obesity
Time Frame: 120 days
Changes in levels of Alanine aminotransferase in mg/dl and Aspartate aminotransferase in mg/dl
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Principal Investigator: Sandra O Hernández González, PhD, Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2022-1301-178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Access Criteria

The data can be shared through a request addressed to the principal investigator Dr. Sandra Ofelia Hernández González, basing the reason for what they are requested.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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