Effect of wheat on appetite and hormones in obese patients

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

This study is testing if a wheat extract can help reduce appetite and balance hormones in people with obesity over 120 days.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 30 Years to 50 Years
• Sex: All
• Sponsor: Coordinación de Investigación en Salud, Mexico (other gov)
• Locations: 1 site (Guadalajara, Jalisco)
• Trial ID: NCT06496100 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Triticum aestivum (wheat) on appetite regulation and hormonal balance in patients diagnosed with obesity. It employs a double-blind, randomized, placebo-controlled design with two parallel groups, where one group receives the wheat extract and the other receives a placebo for 120 days. The study aims to assess changes in hormones such as ghrelin, leptin, and adiponectin, which are crucial for regulating food intake and energy expenditure. Participants will be recruited from the Guadalajara Metropolitan Area and must meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 50 with a diagnosis of obesity and stable body weight.

Not a fit: Patients with diabetes, dyslipidemia, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new natural treatment option for managing obesity and its associated hormonal imbalances.

How similar studies have performed: While the use of natural products for obesity management is explored, this specific approach with Triticum aestivum is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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).

Where this trial is running

Guadalajara, Jalisco

• Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute. — Guadalajara, Jalisco, Mexico (RECRUITING)

Study contacts

• Principal investigator: Sandra O Hernandez Gonzalez, PhD — Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
• Study coordinator: Sandra O Hernandez Gonzalez, PhD

Conditions: Obesity, Leptin Deficiency, Ghrelin, Adiponectin