Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls

NCT06465602 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-20

No results posted yet for this study

Summary

Falls are unplanned events resulting in contact with a lower surface. They are common in older adults, affecting one in three individuals over 65 years old. They have serious consequences, ranging from physical injuries (fractures, traumatic brain injury) to psychological repercussions. Physical training focused on muscle strength, balance, and gait has consistently been shown to prevent falls. However, there are significant challenges in its implementation, such as the need for trained personnel and long intervention times, which are associated with high costs. Therefore, developing strategies to improve the efficiency of physical training programs in older adults is mandatory. The reduced response to physical training in older adults compared to younger individuals is a well-documented phenomenon, reflecting physiological changes associated with aging.

Nicotinamide adenine dinucleotide (NAD+) is an essential coenzyme for cells, mediating energy metabolism and participating in crucial processes such as DNA repair, mitochondrial function, and cell death. As we age, NAD+ levels decrease in various tissues (including the brain and muscle), contributing to the development of aging phenotypes and associated pathologies. Preclinical evidence suggests that increasing NAD+ levels reduces the appearance of aging phenotypes. During physical activity, cellular metabolic pathways that increase the demand for NAD+ to support energy production in mitochondria are activated. This increase in demand is associated with the upregulation of key enzymes involved in NAD+ degradation promoted by exercise. Considering the decrease in cellular levels of this coenzyme associated with aging, it can be hypothesized that NAD+ deficiency may play a significant role in the reduced response of older adults to training programs. Nicotinamide, a water-soluble form of vitamin B3 currently considered a nutritional supplement, is a fundamental precursor for NAD+ synthesis, capable of raising cellular levels of it. It has already been used in clinical practice in the treatment of certain endocrinological and dermatological conditions. This study aims to determine through a randomized clinical trial whether nicotinamide supplementation improves physical performance in older adults at risk of falls undergoing a physical training program.

Conditions

  • Frailty
  • Fall
  • Frailty Syndrome
  • Falls

Interventions

DRUG

Nicotinamide

The subjects will receive 1.5 grams per day of Nicotinamide, orally, for 30 days.

DRUG

Placebo

The subjects will receive 1.5 grams per day of placebo, orally, for 30 days.

Sponsors & Collaborators

  • Centro FONDAP de Gerociencia, Salud mental y Metabolismo (GERO)

    collaborator UNKNOWN
  • Center for Advanced Clinical Research (CICA ) - University of Chile

    collaborator UNKNOWN
  • University of Chile

    lead OTHER

Principal Investigators

  • Felipe H Salech Morales, MD-PhD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2024-11-30
Completion
2025-02-28

Countries

  • Chile

Study Locations

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Entities

Drugs
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 NCT06465602 on ClinicalTrials.gov