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

NCT06501248 | Unknown Phase 3 DMC

• 1 other identifier: R-2022-1301-178
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Drug Effect; Insulin Sensitivity

Outcome Measures

Primary Outcomes (11)

• The effect of Triticum aestivum on glucose in patients with obesity

  Changes in levels of glucose in mg/dl.

  120 days

• The effect of Triticum aestivum on insulin sensitivity in patients with obesity

  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

  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

  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

  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

  Changes in levels of total cholesterol in mg/dl.

  120 days

• The effect of Triticum aestivum on triglycerides in patients with obesity

  Changes in levels of triglycerides in mg/dl.

  120 days

• The effect of Triticum aestivum on body weight in patients with obesity

  Changes in levels of body weight in kilograms.

  120 days

• The effect of Triticum aestivum on Body Mass Index in patients with obesity

  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

  Changes in levels of fat percentage (percentage)

  120 days

• The effect of Triticum aestivum on Waist Hip Index in patients with obesity

  Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters)

  120 days

Secondary Outcomes (3)

• The effect of Triticum aestivum on blood pressure 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 hepatic profile in patients with obesity

  120 days

Study Arms (2)

Triticum aestivum

ACTIVE COMPARATOR

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

Placebo (calcined magnesia)

PLACEBO COMPARATOR

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)

Interventions

Triticum Aestivum DRUG

The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.

Triticum aestivum

Placebo (calcined magnesia) DRUG

The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.

Also known as: Calcined magnesia

Placebo (calcined magnesia)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.

Guadalajara, Jalisco, 44380, Mexico

RECRUITING

Related Publications (25)

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  BACKGROUND

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  PMID: 35335312 BACKGROUND

• Singh N, Verma P, Pandey BR. Therapeutic Potential of Organic Triticum aestivum Linn. (Wheat Grass) in Prevention and Treatment of Chronic Diseases: An Overview [Internet]. Vol. 4, International Journal of Pharmaceutical Sciences and Drug Research. 2012. Available from: www.ijpsdr.com

  BACKGROUND

• Anup S. PHYTOCHEMICAL AND PHARMACOLOGICAL SCREENING OF WHEATGRASS JUICE (TRITICUM AESTIVUM L.). International Journal of Pharmaceutical Sciences Review and Research. 2011; 9(1):159-64.

  BACKGROUND

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• Amira Moheb T. Biochemical, Molecular and Pharmacological Studies of the Wheat (Triticum aestivum L). 2012.

  BACKGROUND

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MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Flour

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sandra O Hernández González, PhD

  Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra O Hernández González, PhD

CONTACT

523336170060; drasandy2003@yahoo.com.mx

María C Espinel Bermúdez, PhD

CONTACT

523336170060; mclaudia_espinel@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: July 15, 2024
• Study Start: July 14, 2022
• Primary Completion: August 30, 2024
• Study Completion: December 10, 2024
• Last Updated: July 15, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication.
• 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.

Locations

ME (1)