Status:
COMPLETED
Effect of a Probiotic on the Glycemic Profile and the Fecal Microbiota of Prediabetic Subjects (PREDIABETCARE)
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
GENBIOMA Aplicaciones SL
Gobierno de Navarra/FEDER
Conditions:
PreDiabetes
Overweight and Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
According to the data from the Di@bet.es study, which is part of the National Diabetes Strategy, the prevalence of type 2 diabetes among Spanish population is 13.8%. Diabetic patients suffer from seve...
Detailed Description
This study is designed as a 12-week, double-blind, randomised, placebo-controlled parallel study. It is focused on prediabetic overweight / obese men and women between 18 and 70 years old. All partic...
Eligibility Criteria
Inclusion
- Men and women aged between 18 and 70 years.
- Prediabetic subjects: glycosylated hemoglobin (HbA1c) between 5.7% and 6.4%.
- Body Mass Index (BMI) between 25 and 39.9 kg / m2.
- No weight changes (± 3 kg) during the last 3 months.
- The subjects must be in general physical and psychological conditions in accordance with the objective of the study.
- Subjects must be able to understand and sign the informed consent.
Exclusion
- To be in continuous pharmacological / hormonal treatment, especially those that could affect blood glucose concentration.
- Suffering from a chronic metabolic disease, or from a systemic intestinal, liver or kidney disease: type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid function disorders, cirrhosis, inflammatory bowel disease, etc.
- Subjects suffering from severe hyperlipidemia, severe hypertension or hypothyroidism without treatment or treated for less than 3 months.
- Presence of relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasia, active peptic ulcers, chronic inflammatory diseases or malabsorption.
- Subjects who have undergone gastrointestinal surgery with permanent sequelae (for example, gastroduodenostomy).
- Chronic treatment with stomach protectors.
- Subjects suffering from some type of cancer or being in treatment for it or with a period less than 5 years since its eradication.
- Presence of some type of mental impairment such as depressive pathology, anxiety or untreated bipolar disorder. They will be able to participate if they have stable treatment for at least 3 months prior to the begining of the trial.
- Allergy or intolerance to any food or food group that is likely to manifest during the study.
- Be on a special diet (Atkins, vegetarian, etc.) during the 3 months prior to the start of the study.
- Weight variations (± 3 kg) during the last 3 months.
- Suffering from eating disorders or eating restrictive behaviors (score on the EAT-26 questionnaire equal or greater than 20).
- Subjects who have undergone surgical treatment for obesity.
- Being pregnant or breastfeeding.
- Abuse of alcohol (more than 14 units in women and 20 units in men) and / or drugs.
- Show poor collaboration or, in the opinion of the investigator, have difficulties in following the study procedures.
- Take some type of nutritional supplementation that can affect blood glucose and / or 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.
- People who are positive for Covid-19 will not be able to participate in the study.
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04863313
Start Date
March 11 2021
End Date
December 9 2022
Last Update
April 20 2023
Active Locations (1)
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1
Center for Nutrition Research. University of Navarra
Pamplona, Navarre, Spain, 31008