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

NCT06496100 | Recruiting Phase 3 DMC

• 1 other identifier: R-2023-1301-251
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Leptin Deficiency; Ghrelin; Adiponectin

Outcome Measures

Primary Outcomes (5)

• To evaluate the effect of Triticum aestivum on leptin in patients with obesity.

  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.

  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.

  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

  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

  To evaluate the effect on satiety by the visual analog scale for satiety and appetite

  120 days

Study Arms (2)

Triticum aestivum

ACTIVE COMPARATOR

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

Placebo (calcined magnesia)

PLACEBO COMPARATOR

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)

Interventions

Triticum Aestivum DRUG

The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.

Triticum aestivum

Placebo (calcined magnesia) DRUG

The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.

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:

• 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.

You may not qualify if:

• 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).

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 Links

• Hypothalamic IKKβ/NF-κB and ER Stress Link Overnutrition to Energy Imbalance and Obesity.
• Issues in Measuring and Interpreting Human Appetite (Satiety/Satiation) and Its Contribution to Obesity.
• Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity
• Proanthocyanidins potentiate hypothalamic leptin/STAT3 signalling and Pomc gene expression in rats with diet-induced obesity.
• Active ingredients from natural botanicals in the treatment of obesity.
• Hunger and Satiety Mechanisms and Their Potential Exploitation in the Regulation of Food Intake.
• STAT3 signalling is required for leptin regulation of energy balance but not reproduction.
• Microglia Dictate the Impact of Saturated Fat Consumption on Hypothalamic Inflammation and Neuronal Function.
• Leptin and the Regulation of Body Weigh.
• Positional cloning of the mouse obese gene and its human homologue.
• The cellular and molecular bases of leptin and ghrelin resistance in obesity.
• Integrative physiology of human adipose tissue.
• Regulation of Jak Kinases by Intracellular Leptin Receptor Sequences.

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Interventions

Flour

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sandra O Hernandez Gonzalez, PhD

  Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra O Hernandez Gonzalez, PhD

CONTACT

523336170060; drasandy2003@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) 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. 38 patients: 1. 19 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days. 2. 19 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

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: July 11, 2024
• Study Start: January 3, 2024
• Primary Completion: November 27, 2024
• Study Completion: December 24, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-03

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)