Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota (NCT05230342) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota
Mexico100 participantsStarted 2022-08-02
Plain-language 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 prediabetes and obesity, which in turn will generate a personalized dietary intervention through a prediction of postprandial blood glucose levels.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* 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 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.
* 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.
What they're measuring
1
Area under the curve of postprandial glucose response
Timeframe: 2 weeks
2
Evaluation of the total daily interstitial glucose over 140 mg/dl
Timeframe: 2 weeks
Trial details
NCT IDNCT05230342
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran