Status:
ACTIVE_NOT_RECRUITING
Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Obesity
Pre Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study will investigate whether changes in the intestinal microbiota generated through a nutritional strategy based on functional foods, modifies postprandial glycemic responses in subjects with p...
Detailed Description
The increase in postprandial blood glucose constitutes a global epidemic and an important risk factor for the development of prediabetes and type 2 diabetes (T2D). Prediabetes is characterized by alte...
Eligibility Criteria
Inclusion
- Male and female.
- Adults between 18 and 60 years of age.
- BMI ≥ 30 and ≤ 50 kg/m2.
- Basal blood glucose 100 - 125 mg/dl
- The signing of the informed consent.
Exclusion
- 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.
- Positive smoking.
- Drug treatment:
- Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitor, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
- Treatment with hypoglycemic agents (sulfonylureas, methylalanines , 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 orlistat.
- Supplements with any of the functional foods used in the study.
- Probiotic, prebiotic or symbiotic supplements.
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05230342
Start Date
August 2 2022
End Date
August 30 2025
Last Update
April 24 2025
Active Locations (2)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico, 14080
2
Armando Roberto Tovar Palacio
Mexico City, Mexico, 14080