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.
Male and female
Adults between 18 and 60 years of age.
The signing of the informed consent.
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.
Single group
Dietary Supplement: A package containing a mix of functional foods
Dietary supplementParticipants 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.
Changes in postprandial glucose responses
Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol\*minutes/litre.
Changes in diversity analysis of intestinal microbiota with and without intervention with functional foods
Based on the gene and species composition of each sample, the Chao1 and Shannon indexes, as well as the observed operational taxonomic units, will be calculated in order to identify the differences in gene and species diversity for each group
Changes in metabolite profiles of urine with and without intervention with functional foods
Metabolite profiles will be analyzed using a semi targeted screening approach with multiple Schedule multiple reaction monitoring-independent data acquisition-enhanced product ion experiments in an liquid chromatography-mass spectrometer-triple quadrupole with linear trap mass spectrometer metabolomic platform. The concentration of the identified metabolites in the different urinary fractions will be expressed in relative intensities. From the latter, putative biomarkers may be obtained to determine the fingerprint of the dietary intervention assessed in this clinical trial.
Feasibility of the functional food treatment decision algorithm. Proportion of patients with presumed improvement in postprandial glucose response who have completed the algorithm.
The algorithm will be considered completed if a decision to initiate functional food intervention has been taken at any step of the algorithm or if improvement in the prediction of postprandial glucose response has been excluded after systematic evaluation, and all steps planned in the algorithm have been implemented.
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead sponsor
Fundación Gonzalo Río Arronte
Collaborator
