Effects of Functional Foods on Blood Sugar Levels and Gut Health
Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults
This study is testing how eating special foods can affect blood sugar levels and gut health in adults aged 18 to 60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT05723913 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates how functional foods influence postprandial glucose levels and gut microbiota in adults aged 18 to 60. Over a 42-day period, participants will undergo three phases: 14 days without intervention, 14 days with functional food supplementation, and another 14 days without intervention. Continuous glucose monitoring will track glucose levels every 15 minutes, while changes in gut microbiota and urine metabolites will also be assessed. The goal is to understand how these interventions can modify glycemic responses.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 60 who do not have diabetes or other metabolic disorders.
Not a fit: Patients with diabetes, high blood pressure, or significant gastrointestinal diseases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary strategies for managing blood sugar levels and improving gut health.
How similar studies have performed: Other studies have shown promising results in using dietary interventions to manage postprandial glucose levels, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female * Adults between 18 and 60 years of age. * The signing of the informed consent. Exclusion Criteria: * Patients with any type of diabetes. * Patients with high blood pressure. * Patients with acquired diseases secondarily producing obesity and diabetes. * Patients who have suffered a cardiovascular event. * Patients with gastrointestinal diseases. * Weight loss \> 3 kg in the last 3 months. * Catabolic diseases such as cancer and acquired immunodeficiency syndrome. * Pregnancy status. * Drug treatment: * Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers). * Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs. * Treatment with statins, fibrates or other drugs to control dyslipidemia. * Use of antibiotics in the three months prior to the study. * Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy. * Anorexigenic or that accelerate weight loss such as sibutramine or orlistat. * Supplements with any of the functional foods used in the study. * Probiotic, prebiotic or symbiotic supplements.
Where this trial is running
Mexico City, Mexico City
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Armando R Tovar, Doctor — Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
- Study coordinator: Armando R Tovar, Doctor
- Email: tovar.ar@gmail.com
- Phone: 52 5554870900
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.