Triticum Aestivum effects on obesity and insulin sensitivity
Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
This study is testing if a wheat extract can help people with obesity improve their insulin sensitivity and overall metabolic health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT06501248 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Triticum Aestivum on metabolic profile components and insulin sensitivity in patients diagnosed with obesity. It is a double-blind, randomized, placebo-controlled study involving two parallel groups, with one group receiving Triticum Aestivum and the other receiving a placebo for 120 days. The study aims to assess changes in metabolic parameters such as blood pressure, cholesterol, and triglycerides among participants. A total of 36 patients from the Guadalajara Metropolitan Area will be enrolled, all of whom must meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are Mexican adults aged 30 to 50 with a BMI between 30 and 39.9 kg/m2 and stable body weight.
Not a fit: Patients with a history of smoking, pregnancy, or those currently on pharmacological treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention for improving metabolic health in obese patients.
How similar studies have performed: While there is limited data on the specific use of Triticum Aestivum for obesity, similar dietary interventions have shown promise in improving metabolic profiles in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
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 Hernández González, PhD — Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
- Study coordinator: Sandra O Hernández González, PhD
- Email: drasandy2003@yahoo.com.mx
- Phone: 523336170060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.