Blueberry Extract + Limosilactobacillus Reuteri for Age-Related Immune Decline

(PreMIS Trial)

DA
Overseen ByDavid A Welsh, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Louisiana State University Health Sciences Center in New Orleans
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if blueberry extract and the probiotic Limosilactobacillus reuteri can slow age-related immune decline, particularly in individuals with HIV who consume alcohol. By testing these treatments, researchers seek to assess their impact on signs of immune system aging. Participants will receive both treatments in varying sequences, with a break in between. Individuals over 40 years old, living with HIV, and who regularly consume alcohol may qualify for this study. As a Phase 1/Phase 2 trial, the research focuses on understanding the treatments' effects and measuring their effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have used probiotics, antibiotics, or immunosuppressives recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research found that blueberry extract improved brain function and helped with age-related decline, increasing brain activity in older animals to levels similar to younger ones. Other studies have shown that blueberries enhance memory and overall brain health in older adults, suggesting that blueberry extract is generally safe and well-tolerated in humans.

Research also shows that Limosilactobacillus reuteri, a type of probiotic, is safe. It benefits gut health and immune function in healthy adults. This probiotic has been tested without major issues in various groups, including children and those with weaker immune systems.

Both treatments—blueberry extract and Limosilactobacillus reuteri—have a strong safety record in humans. They are well-tolerated, with no serious side effects reported in these studies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of blueberry extract and Limosilactobacillus reuteri for age-related immune decline because these treatments use natural ingredients with promising health benefits. Unlike traditional medications that might involve synthetic compounds, this approach leverages the antioxidant properties of blueberries and the gut health benefits of Limosilactobacillus reuteri. Blueberry extract is rich in antioxidants, which help combat oxidative stress, a key factor in immune decline as we age. Meanwhile, Limosilactobacillus reuteri is a probiotic that can enhance gut health, which is closely linked to a stronger immune system. This combination could provide a more holistic and gentle way to support aging immune systems compared to conventional drugs.

What evidence suggests that this trial's treatments could be effective for age-related immune decline?

This trial will examine the effects of blueberry extract and Limosilactobacillus reuteri on age-related immune decline. Studies have shown that blueberry extract can reduce signs of aging in the brain, linking it to improved thinking and memory, which often decline with age. Research also suggests that Limosilactobacillus reuteri, a type of probiotic, may enhance the immune system by balancing gut bacteria and supporting overall immune health. Both treatments are considered safe and have shown promise in reducing age-related decline, prompting their study in separate sequences in this trial. Participants will receive either the probiotic followed by blueberry extract or blueberry extract followed by the probiotic, with a washout period in between.45678

Who Is on the Research Team?

DA

David A Welsh, MD

Principal Investigator

LSU Health New Orleans

Are You a Good Fit for This Trial?

This trial is for people aged 40 or older who have HIV and have recently consumed a moderate amount of alcohol (at least about 3 drinks in the past week, confirmed by a urine test).

Inclusion Criteria

I am 40 years old or older.
* People with HIV
* Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either Limosilactobacillus reuteri probiotic or blueberry extract for 4 weeks

4 weeks
2 visits (in-person)

Washout

A 6-week washout period to minimize potential carryover effects

6 weeks

Treatment Period 2

Participants crossover to the alternate intervention for 4 weeks

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Blueberry extract
  • Limosilactobacillus reuteri

Trial Overview

The study tests whether blueberry extract or Limosilactobacillus reuteri (a probiotic) can help reduce signs of immune system aging. Participants receive both treatments at different times in a randomized, double-blind, crossover design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sequence B: Blueberry Extract then ProbioticExperimental Treatment2 Interventions
Group II: Sequence A: Probiotic then Blueberry ExtractExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials
123
Recruited
42,400+

Citations

Blueberry Extract + Limosilactobacillus Reuteri for Age- ...

This randomized, double-blind, crossover clinical trial evaluates two generally recognized as safe (GRAS) microbiota-targeted interventions on immune senescence ...

An 8-week freeze-dried blueberry supplement impacts ... - PMC

All results remained unchanged after adjustment for age, sex and BMI (data not shown). ... outcomes, particularly those related to immunity. MetS-related ...

Blueberry Extract - an overview

Blueberry supplementation diet with aged male Fischer 344 rats significantly attenuated aging-related increase in NF-κB expression in the frontal cortex, ...

Effect of berry-based supplements and foods on cognitive ...

Existing evidence concludes that berry-based supplements and foods have beneficial effects on resting brain perfusion, cognitive function, memory performance.

Therapeutic potential of berries in age-related neurological ...

According to current clinical investigations, berries improve motor and cognitive functions and protect against age-related neurodegenerative diseases.

Blueberry-enriched diet ameliorates age-related declines in ...

Supplementation of the diet with blueberry extract elevated LTP (63%) in aged animals to levels seen in young. The normalization of LTP may be due to the ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38674870/

Wild Blueberry Extract Intervention in Healthy Older Adults

Existing evidence shows that anthocyanin-rich foods such as berries may improve or attenuate the decline in EF and EM in ageing adults.

Blueberry

Aging and related health concerns: There are conflicting data from RCTs, but blueberries may improve vascular function and observational studies ...