Effect of a Probiotic on the Glycemic Profile and the Fecal Microbiota of Prediabetic Subjects (PREDIABETCARE)

NCT04863313 | Completed

• 1 other identifier: PREDIABETCARE
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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 several short and long term complications, which are related to a significant worsen of quality of life and a substantial increase in death rate. In this sense, it is important to prevent the development of Type 2 diabetes. Therefore, it is of high relevance to identify and to treat prediabetic subjects prior to the development of the disease. Many strategies have been implemented to reverse this situation, such as changes in diet and lifestyle, among others. However, it is hard to achieve changes in lifestyle and despite the use of some drugs in this phase of the disease, the problem continues growing. For this reason, new strategies to combat the development of type 2 diabetes are been investigated, such as the use of probiotic formulations. However, at the moment, few studies evidence the effect of probiotics on glycemic regulation. Therefore, an interesting opportunity arises according to the potential ability of probiotic formulation for the control of prediabetes. Considering this background, the main objective of this research is to assess the effect of a new probiotic formulation on glycemic control, insulin resistance and the composition of the fecal microbiota in prediabetic subjects.

Conditions

PreDiabetes; Overweight and Obesity

Keywords

Prediabetes; Obesity and overweight; Glycated hemoglobin; Blood glucose; Fecal microbiota; Probiotic

Outcome Measures

Primary Outcomes (1)

• Change of blood glycated hemoglobin (HbA1c) concentration from baseline to week 12.

  Fasting blood glycated hemoglobin (HbA1c) concentration will be reported in % and in mmol/mol.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Secondary Outcomes (49)

• Change of metagenomic analysis of intestinal microbiota composition from baseline to week 12.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

• Change of fasting blood glucose concentration from baseline to week 4.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).

• Change of fasting blood glucose concentration from baseline to week 8.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).

• Change of fasting blood glucose concentration from baseline to week 12.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

• Oral glucose tolerance test

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Study Arms (2)

Group receiving the probiotic capsules

EXPERIMENTAL

Experimental group will consume one probiotic capsule every day during 12 weeks at breakfast.

Dietary Supplement: Probiotic

Group receiving the placebo capsules

PLACEBO COMPARATOR

Placebo group will consume one placebo capsule every day during 12 weeks at breakfast.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Experimental group will consume one probiotic capsule every day during 12 weeks at breakfast.

Group receiving the probiotic capsules

Placebo DIETARY_SUPPLEMENT

Placebo group will consume one placebo capsule every day during 12 weeks at breakfast.

Group receiving the placebo capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• GENBIOMA Aplicaciones SL: collaborator
• Gobierno de Navarra/FEDER: collaborator

Study Sites (1)

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• María Jesús Moreno Aliaga, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

• Carlos González Navarro, PhD

  University of Navarra

  STUDY DIRECTOR

• Pedro González Muniesa, PhD

  University of Navarra

  STUDY CHAIR

• Idoia Ibero Baraibar, PhD

  University of Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: March 11, 2021
• Primary Completion: July 20, 2022
• Study Completion: December 9, 2022
• Last Updated: April 20, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)