Aging Resilience Through Microbiota Optimization and Regulation

Summary

Sarcopenia, characterized by the progressive loss of muscle mass and strength in older adults, is a key factor in health deterioration. It affects 15% of people between 65 and 80 years old and over 50% of those over 80, compromising autonomy and increasing the risk of diseases. Sarcopenia not only impacts muscle function but also bone health, mobility, and is associated with cardiometabolic diseases and cognitive decline.

It has been proposed that changes in the gut microbiota in aging individuals, known as gut dysbiosis, contribute to sarcopenia. Species diversity decreases, and bacterial representation is altered, which could impair muscle function through various pathways, such as mitochondrial dysfunction, chronic inflammation, and disruption of protein synthesis. Muscle function loss is strongly associated with cognitive and metabolic impairment in older adults.

Recently, it has been demonstrated that fecal microbiota transplantation (FMT) is an effective procedure for modulating gut microbiota and has proven highly effective in managing cases of Clostridium difficile-associated chronic diarrhea. The main objective of this project is to carry out FMT from young, physically active donors to a cohort of older adults to evaluate its effect on muscle, cognitive, and metabolic function.

Why donors who exercise? There is growing evidence that gut microbiota diversity is increased in young, physically active individuals. The FMT is planned to be administered through lyophilized microbiota capsules. By restoring microbial diversity, it is expected to improve the quality and function of skeletal muscles, leading to greater cognitive and metabolic resilience.

This project has great potential to develop an innovative approach for treating highly debilitating diseases that affect older adults, based on the lyophilization and encapsulation of gut microbiota from young, trained donors, which can be easily stored in a conventional freezer. Due to the high percentage of older adults worldwide and the high prevalence of sarcopenia within this age group, the aim of the project is to address a significant public health issue with a large target population eager for options to promote muscle health, functional autonomy, as well as cognitive and metabolic well-being.

Conditions

• Resilience
• Cognitive Function and Well-Being
• Muscle Function, Handgrip Strength Test
• Insulin Sensitivity

Interventions

DIETARY_SUPPLEMENT

FMT capsule

A lyophilized gut microbiota capsule derived from a rigorously screened, healthy, and physically active donor, free of gastrointestinal diseases, antibiotic use, and chronic conditions. The donor diverse microbiome is supported by a nutrient-rich diet and active lifestyle. The lyophilization process preserves microbial integrity, offering a high-potency dose aimed at restoring and optimizing the gut microbiome of older adults. This intervention is specifically designed for older adults to enhance resilience to stress, cognitive function, muscular strength, and metabolic health. It is part of a controlled clinical study with follow-up assessments at weeks 1, 4, 8, and 20 post-intervention. This targeted approach distinguishes it from other microbiome-based therapies by focusing on comprehensive health benefits for an aging population.

DIETARY_SUPPLEMENT

Placebo Capsule(s)

A placebo capsule will be used in this study to serve as a control, allowing us to objectively assess the true effects of the lyophilized gut microbiota intervention. The use of a placebo is essential to eliminate bias and ensure that any observed outcomes can be confidently attributed to the actual intervention rather than to psychological or other non-specific effects. The placebo capsule will be identical in appearance, size, shape, and color to the interventional capsule to maintain blinding for both participants and researchers. This ensures that neither group knows which capsule is being administered, thereby preserving the study's integrity and validity by preventing any expectations or beliefs from influencing the results.

Sponsors & Collaborators

• Universidad de los Andes, Chile

  collaborator OTHER

• Gonzalo Jorquera, PhD

  lead OTHER

Principal Investigators

• Gonzalo Jorquera, PhD · University of Chile

• Ricardo Espinoza, MD · Universidad de Los Andes

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-10

Primary Completion

2026-09-30

Completion

2027-09-30

Countries

• Chile

Study Locations