Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls (NICE-FIT)

June 13, 2024 updated by: University of Chile

Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls: a Pilot Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To test the hypothesis, a randomized pilot clinical trial will be conducted using block allocation, double-blind (patient and evaluator), designed according to the SPIRIT guidelines for drafting a trial protocol. This study involves the implementation of guided home-based physical training by a physiotherapist (2 sessions per week for 4 weeks) combined with supplementation with nicotinamide (1.5 g/day) or placebo depending on the assigned group. Improvement in physical performance will be evaluated using the Short Physical Performance Battery (SPPB), handgrip strength test, quadriceps dynamometry, posturography, and near-infrared spectroscopy (NIRS) of the quadriceps. The RedCap software will be used for randomization and data analysis.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Felipe H Salech Morales, MD PhD
  • Phone Number: +56 229788546
  • Email: fhsalech@uchile.cl

Study Contact Backup

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Hospital Clínico Universidad de Chile
        • Contact:
          • Felipe Salech, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotinamide supplementation group
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
The subjects will receive 1.5 grams per day of Nicotinamide, orally, for 30 days.
Other Names:
  • Niacinamide
Placebo Comparator: Placebo group
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
The subjects will receive 1.5 grams per day of placebo, orally, for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in physical performance
Time Frame: Four weeks
Assess the change in total Short Physical Performance Battery (SPPB) performance from baseline to post-4 weeks
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posturography
Time Frame: Four weeks
Change Center of pressure (COP) between baseline and post-training in posturography
Four weeks
Dynamometry
Time Frame: Four weeks
Change in dynamometry performance between baseline and post-training
Four weeks
Quadriceps saturation
Time Frame: Four weeks
Change in quadriceps saturation after a 5-squat test
Four weeks
Adherence to medication
Time Frame: Four weeks
Nicotinamide/placebo usage via self-report survey
Four weeks
Adverse effects
Time Frame: Four weeks
Assessment of adverse effects using a standardized evaluation guideline.
Four weeks
Plasma sample analysis
Time Frame: Four weeks
Nicotinamide leves, Interleukin-13 (IL-13), Interleukin-1(IL-1), Interleukin-6 (IL-6), mixed lineage kinase domain-like (MLKL), receptor interacting protein kinase 3 (RIPK3) and chemokine C-C ligand 2 (CCL-2)
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

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

Investigators

  • Principal Investigator: Felipe H Salech Morales, MD-PhD, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONDAP 15150012 GERO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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