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NCT05230342Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (actual)
First submitted
7 Jan 2022
Start date
2 Aug 2022
Primary completion date
31 May 2025
Lead sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Diseases
Obesity
NCT number
NCT05230342

What you commit to

  • Study type: Interventional
  • Participants enrolled: 100
  • From 2 Aug 2022 to the primary completion date, 31 May 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with any type of diabetes.
  • Patients with acquired diseases secondarily producing obesity and diabetes.
  • Patients with gastrointestinal diseases.
  • Catabolic diseases such as cancer and acquired immunodeficiency syndrome.

Lab values

  • 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.

Other

  • Patients with high blood pressure.
  • Patients who have suffered a cardiovascular event.
  • Weight loss \> 3 kg in the last 3 months.
  • Pregnancy status.
  • Positive smoking.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
Armando Roberto Tovar Palacio
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.