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Supplementation of Inulin + L. Acidophilus in Elders with T2DM

NCT06830824 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-19

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Lactobacillus acidophilus

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Anahuac University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-08-31
Completion
2025-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830824 on ClinicalTrials.gov