Health TrialsbyHealthPanel

Supplementation of Inulin + L. Acidophilus in Elders with T2DM

ConditionsDiabetes MellitusMicrobiomeCognition Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorAnahuac University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

  • Placebo

    Other intervention

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Phase 1Active comparator 1 intervention
Group B: Phase 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 weeks
2

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

Time frame
8 weeks
3

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

Time frame
16 weeks

Secondary outcomes

1

Stool microbiome

Stool Microbiota Sequencing: Assessment of gut microbiota composition at the end of both stages

Time frame
16 weeks
2

Stool butyrate

Butyrate Measurement: Determination of butyrate levels in fecal samples to correlate with cognitive and metabolic outcomes.

Time frame
16 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anahuac University

Lead sponsor

Source ClinicalTrials.gov

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