Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.

Korábbi kezelés

• Subjects who have received oral antibiotic treatment in the 45 days prior to the start of the study.
• Patients who have started hypoglycemic treatment, especially in the 3 months prior to inclusion. Insulin treatment.
• Subjects who have undergone surgical interventions of the digestive system with permanent consequences (for example, gastroduodenostomy).
• Presence of some type of psychological impediment such as depressive pathology, anxiety, untreated bipolar disorder. They will be able to participate if they have the disease but with stable treatment for at least 3 months prior to the start of the trial.
• Be on a special diet during the 3 months prior to the start of the study, except for treatment for DM2, in this case, the lifestyle/diet will have to be stable in the 3 months prior to the start of the study.
• Subjects who have undergone surgical treatment for obesity.
• Present alcohol abuse (more than 14 units/day in women and 20 units/day in men) and/or drugs.

Más betegség

• Severe untreated dyslipidemia, hypertension or hypothyroidism, or treated for less than 3 months.
• Presence of relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory diseases or malabsorption.
• Suffer from any type of cancer or be undergoing treatment for it, or a period of less than 5 years since its eradication.
• Have an allergy or intolerance to any food or food group that is likely to manifest during the study.
• Suffer from eating disorders or present restrictive behaviors in their diet. Score on the EAT-26 questionnaire equal to or greater than 20.

Laborértékek

• Take some type of nutritional supplementation that can affect blood glucose and/or the microbiota. If they take it, in order to be included in the study, they will have to stop the supplement, with a washout period of at least 14 days before starting the study.

Egyéb

• Subjects who work rotating shifts that include night shifts.
• Weight variations (± 5%) during the last 3 months.
• Be pregnant or breastfeeding.
• Show poor collaboration or have difficulties to follow the study procedures.

• Men and women aged between 18 and 70 years.
• Subjects diagnosed with DM2: glycosylated hemoglobin (HbA1c) ≥6.5% and/or basal glucose ≥126 mg/dL. Debut time will not be taken into account.
• Body Mass Index (BMI) between 25 and 39.9 kg/m2.
• Treatment for DM2/stable lifestyle, as well as other treatments for other pathologies (stable at least 3 months prior to the start of the intervention).
• Stable baseline HbA1c or glucose value for at least 3 months before starting the intervention.
• No weight variations (± 5%) during the last 3 months.
• Subjects must be in general physical and psychological conditions that the researcher assesses in accordance with the objective of the study.
• Subjects must be able to understand and be willing to sign the informed consent, and must comply with all study procedures and requirements.