Clinical trial

Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05230342

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Pre Diabetes

Full registry criteria

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.

Treatments and study arms

A package containing a mix of functional foods

Dietary Supplement

Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein and genistein.

Placebo ingredient group

Other

The control group will receive a comparable set of food items that contain an equivalent number of calories per portion but without the added functional ingredients

Primary outcomes

Area under the curve of postprandial glucose response2 weeks

Compare the effect between a nutritional strategy based on functional foods and the placebo group on postprandial glycemic response in subjects with obesity

Evaluation of the total daily interstitial glucose over 140 mg/dl2 weeks

Total daily interstitial glucose levels will be evaluated by using Continuous glucose monitoring (CGM).

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Armando Roberto Tovar Palacio🇲🇽 Mexico City, Mexico

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán🇲🇽 Mexico City, Mexico City, Mexico

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