Supplementation of Inulin + L. Acidophilus in Elders with T2DM

NCT06830824 | Not Yet Recruiting DMC

• 1 other identifier: 202439
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates the effects of a symbotic supplement (Inulin + Lactobacillus acidophilus) on cognitive impairment in older adults with type 2 diabetes mellitus (T2DM). Diabetes is a chronic disease characterized by insulin deficiency or resistance, leading to hyperglycemia and long-term complications, including cognitive decline. Cognitive impairment in T2DM patients is linked to oxidative stress, neuroinflammation, and disrupted insulin signaling in the brain. The gut-brain axis plays a crucial role in cognition, with gut microbiota influencing neuroinflammatory processes. Dysbiosis, common in T2DM, exacerbates cognitive decline. Probiotics like Lactobacillus acidophilus and prebiotics like inulin can restore gut microbiota balance, reduce inflammation, and promote brain-derived neurotrophic factor (BDNF) production, improving cognitive function. This randomized, crossover clinical trial will enroll 24 patients aged 50-65 with T2DM and mild cognitive impairment. Participants will be divided into control and experimental groups, with an 8-week intervention phase followed by a crossover. The experimental group will receive 8g of inulin and L. acidophilus daily, while the control group will receive a placebo. Cognitive assessments (MMSE, MoCA), PET-CT imaging, gut microbiota sequencing, and butyrate measurements will evaluate the intervention's effects. The study aims to determine whether symbiotic supplementation can improve cognitive function and metabolic brain activity in T2DM patients. If successful, it may offer an accessible, non-pharmacological approach to mitigating diabetes-related cognitive decline. The research is funded by the Universidad Anáhuac Health Sciences Research Center and international diabetes research organizations.

Conditions

Diabetes Mellitus; Microbiome; Cognition Disorders

Keywords

Diabetes Mellitus; Supplementation; Cognitive impairment

Outcome Measures

Primary Outcomes (3)

• Cognitive Impairment

  Change in Score in the Folstein Mini Mental Examination, with a higher score (improvement in cognitive impairment) Scoring: 24-30 Uncertain Cognitive Impairment 18-23 Mild to Moderate Cognitive Impairment 0-17 Severe Cognitive Impairment 0 being the lowest and 30 the highest score obtained

  8 weeks

• Cognitive Impairment

  Higher score in Montreal Cognitive Assessment (MoCA), with a total possible score of 30 points, considering a score of 26 or above normal. With the following ranges: Normal range: 26 and above Mild cognitive impairment (MCI): 18-25 Moderate cognitive impairment: 10-17 Severe cognitive impairment: Below 10

  8 weeks

• Cognitive Impairment

  PET-CT with F18-FDG: To be performed at the conclusion of both stages using F18-FDG as a marker to analyze brain metabolic changes

  16 weeks

Secondary Outcomes (2)

• Stool microbiome

  16 weeks

• Stool butyrate

  16 weeks

Study Arms (2)

Phase 1

ACTIVE COMPARATOR

Dietary Supplement: Lactobacillus acidophilus

Phase 2

PLACEBO COMPARATOR

Other: Placebo

Interventions

Lactobacillus acidophilus DIETARY_SUPPLEMENT

A pack of symbiotic powder with 1 gram of e. facieum and 8g of agave inulin will be administered daily for 8 weeks

Phase 1

Placebo OTHER

A pack of unsweetened almond powder milk will be administered daily for 8 weeks

Phase 2

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 60-90 years of age with a diagnosis of DM2 who present some degree of cognitive impairment, assessed with the scales.
• Patients who sign the informed consent form.

You may not qualify if:

• Patients who in the development of the study present comorbidities that influence cognitive impairment.
• Patients who present adverse effects to supplementation.
• Patients who decide to abandon the study or withdraw informed consent. - -Patients who do not take the symbiotic for 3 consecutive doses.

Sponsors & Collaborators

• Anahuac University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Cognition Disorders; Cognitive Dysfunction

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Research Institute of Universidad Anahuac, Principal Investigator

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02