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

Study Overview
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Brief Summary
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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.

Detailed Description
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The increase in postprandial blood glucose constitutes a global epidemic and an important risk factor for the development of prediabetes and type 2 diabetes (T2D). In addition, the elevated postprandial glycemic responses (PPGRs) are an independent risk factor for the development of T2D and are associated with the presence of obesity. Therefore the prediction of PPGRs is a tool that could be used to maintain normal blood glucose concentrations. Studies have shown inter and intrapersonal differences in PPGRs after consuming the same amount of the same food. Factors that can affect interpersonal differences in PPGRs include genetics, lifestyle, and insulin sensitivity. Another factor that may be involved is the gut microbiota. The objective of this study is to characterize the postprandial blood glucose levels, gut microbiota and urine metabolites in participants over 18 years of age after a functional foods intervention and observed whether this intervention modifies the postprandial glycemic response through the gut microbiota and urine metabolites. This will be a 42-day study divided into three phases of 14 days each where the patient will attend four visits: at day 1, 14, 28 and 42. 200 adults who meet the inclusion criteria will be recruited. During the three phases a continuous glucose monitor will be taking intersticial glucose concentrations every 15 min., 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.In the three phases the following will be determined; anthropometric and biochemical parameters, food consumption, physical activity, lifestyle, metabolites in urine as well as determination of the composition of the intestinal microbiota.

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

Conditions
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Healthy, Nutritional and Metabolic Diseases

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: A package containing a mix of functional foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female Adults between 18 and 60 years of age. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional strategy based on functional foods<br>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. | Dietary Supplement: Dietary Supplement: A package containing a mix of functional foods<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 
| 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 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (sMRM-IDA-EPI) experiments in an liquid chromatography-mass spectrometer-triple quadrupole with linear trap mass spectrometer (LC-MS-QTRAP) 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. | 6 weeks | 
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial glucose responses, Gut microbiota, Functional foods