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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Enrolling

Conditions: Healthy; Nutritional and Metabolic Diseases

Treatments: Dietary Supplement: Dietary Supplement: A package containing a mix of functional foods

Study type: Interventional

Funder types: Other

Identifiers

NCT05723913

3312B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Nutritional strategy based on functional foods

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary Supplement: A package containing a mix of functional foods