Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity

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

Effect of Triticum Aestivum on Appetite Regulation and the Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity

Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake, satiety, energy expenditure and weight.

Despite being a highly prevalent disease with major complications, current therapeutic options are not sufficient, as they are not ideal for the entire population. The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality.

Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction, insulin resistance and modulation of neuropeptides involved in food intake.

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.

Two parallel groups, with randomization by software using envelopes, will require a total of 38 patients, which will be distributed as follows: 1) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days, and 2) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules of placebo (calcined magnesia) orally every 12 hours for 120 days.

Study Type

Interventional

Enrollment (Estimated)

38

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 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:
        • Contact:
        • Principal Investigator:
          • Sandra O Hernández González, PhD
        • Sub-Investigator:
          • Miguel A Cardenas Sosa, MSPH

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:

People of any sex (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment).

Age from 30 to 50 years old. Residents of the metropolitan area of Guadalajara. Signed informed consent form. 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.

Exclusion Criteria:

Diagnosis of diabetes and dyslipidemia. Diagnosis of anxiety and/or depression. History of: liver disease, chronic kidney disease, thyroid disease, cancer. Antidiabetic treatment, lipid-lowering, food supplements, antidepressants, corticosteroids.

Acute infectious processes Alcoholism and/or active smoking in any intensity within the 12 months prior to the start of the study.

Suspected or confirmed pregnancy or breastfeeding. History of drug intake. Recent surgery (<3 months) Carrying a pacemaker, or any other bioelectronic or metallic element. 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 per day.

Intake of anorexigenic drugs, hypolipidemic drugs or drugs with effect on body weight.

History of any type of cancer, hyperthyroidism, hypothyroidism, renal disease, liver disease and pancreatic disease.

History of hypersensitivity to the study drug (gluten).

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 19 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, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.
Placebo Comparator: Placebo (calcined magnesia)
A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of calcined magnesia orally every 12 hours for 120 days.
Drug: Placebo (calcined magnesia)
The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.
Other Names:
  • Calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of Triticum aestivum on leptin in patients with obesity.
Time Frame: 120 days
To quantify the serum concentrations of leptin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
120 days
To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity.
Time Frame: 120 days
To quantify the serum concentrations of ghrelin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
120 days
To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity.
Time Frame: 120 days
To quantify the serum concentrations of adiponectin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
120 days
To evaluate the effect of Triticum aestivum on satiety regulation
Time Frame: 120 days
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
120 days
To evaluate the effect of Triticum aestivum on appetite regulation
Time Frame: 120 days
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
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.

Helpful Links

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)

January 3, 2024

Primary Completion (Estimated)

November 27, 2024

Study Completion (Estimated)

December 24, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2023-1301-251

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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