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

NCT06465602 | Recruiting Phase 2

• 1 other identifier: FONDAP 15150012 GERO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nicotinamide; Nicotinamide supplementation; motor rehabilitation; rehabilitation; exercise; falls; older adults; accidental falls; frail older adults; dietary supplementation

Outcome Measures

Primary Outcomes (1)

• Improvement in physical performance

  Assess the change in total Short Physical Performance Battery (SPPB) performance from baseline to post-4 weeks

  Four weeks

Secondary Outcomes (6)

• Posturography

  Four weeks

• Dynamometry

  Four weeks

• Quadriceps saturation

  Four weeks

• Adherence to medication

  Four weeks

• Adverse effects

  Four weeks

Study Arms (2)

Nicotinamide supplementation group

EXPERIMENTAL

At the beginning and end of the study, blood samples will be taken for the measurement of IL-6, CCL2, TNF-alpha, and NFL, and participants will be assessed using the Short Physical Performance Battery (SPPB), quadriceps dynamometry (LY-D Lynx Dynamo), quadriceps oxygen saturation (with NIRS), and posturography to determine the center of pressure (COP) area with the HUR BTG4 posturography system, and SmartBalance® software. Subjects will receive 1.5 grams per day of nicotinamide, orally, for 30 days. During this period, they will undergo a home-based physical training program guided by a physiotherapist. The sessions will be 50 minutes long (10 minutes warm-up, 30 minutes strength and balance training, and 10 minutes flexibility), twice a week.

Drug: Nicotinamide

Placebo group

PLACEBO COMPARATOR

Same physical evaluation and blood sampling as the experimental group. The subjects will receive 1.5 grams per day of placebo (talc, the medium in which nicotinamide is prepared), orally, for 30 days. The bottle and the capsules will be of the same physical characteristics (shape, color, and flavor) in both groups. During that period, patients will assess patient adherence and possible adverse effects.

Drug: Placebo

Interventions

Nicotinamide DRUG

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

Also known as: Niacinamide

Nicotinamide supplementation group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years or older
• Living in the community
• Increased risk of falls, defined as:
• More than two falls in the last 12 months or
• Altered balance test (unable to maintain unipedal stance \> 5 seconds) or
• SPPB score less than 10 points

You may not qualify if:

• Known Muscle Disease (dystrophy, myopathy, or similar)
• Motor sequelae of stroke
• Joint pathology with severe pain preventing strength exercises
• Cognitive impairment that renders the informed consent process impossible.

Sponsors & Collaborators

• University of Chile: lead
• Centro FONDAP de Gerociencia, Salud mental y Metabolismo (GERO): collaborator
• Center for Advanced Clinical Research (CICA ) - University of Chile: collaborator

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Chile

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Felipe H Salech Morales, MD-PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe H Salech Morales, MD PhD

CONTACT

229788546; fhsalech@uchile.cl

María Isabel Behrens, MD

CONTACT

229789404; miobehrens@hcuch.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be assigned to either Nicotinamide or placebo through block allocation. One researcher will be responsible for patient recruitment via telephone and obtaining informed consent. Another researcher will perform patient randomization and drug dispensing. Physiotherapists conducting both the initial and final physical assessments and those conducting rehabilitation sessions will be blinded to the patient's assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized clinical trial, block allocation, double-blind

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: May 21, 2024
• Primary Completion: November 30, 2024
• Study Completion: February 28, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)