RecruitingNot ApplicableNCT05723913

Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults


Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Enrollment

200 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a clinical study with participants over 18 years of age that meet the selection criteria. This will be 42-day study divided into three phases of 14 days each: 14 days without intervention, 14 days with intervention with functional foods and 14 days without intervention again. With the objective of assess the changes in the postprandial glycemic responses through the gut microbiota and urine metabolites.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • Male and female
  • Adults between 18 and 60 years of age.
  • The signing of the informed consent.

Exclusion Criteria17

  • 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.

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Interventions

DIETARY_SUPPLEMENTDietary Supplement: A package containing a mix of functional foods

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, agave extract and genistein.


Locations(1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, Mexico

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NCT05723913


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