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FrailtyPhase 2NICE-FITNCT06465602

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

A Phase 2 study testing Nicotinamide in people with Frailty and Fall, run by University of Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Fall, Frailty Syndrome
What is being tested?
Nicotinamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChile
Study dates
21 May 2024to 28 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Felipe H Salech Morales, MD PhD contact

229788546 ext. +56

fhsalech@uchile.cl

María Isabel Behrens, MD contact

229789404

miobehrens@hcuch.cl

Chile1 site, 1 recruiting

  • Hospital Clínico Universidad de Chile

    Santiago

    Felipe Salech, MD PhD

    Recruiting

Other trials in Chile

About this study

Official title: 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.

Read the 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.

Being tested
Nicotinamide, Placebo
Keywords
nicotinamide, Nicotinamide supplementation, motor rehabilitation, rehabilitation, exercise, falls, older adults, accidental falls, frail older adults, dietary supplementation
Medical subject headings
Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicotinamideDrug

    Also called Niacinamide

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

  • PlaceboDrug

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

Study groups in NCT06465602
Study groupRoleWhat they receive
Nicotinamide supplementation groupExperimentalAt 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.
Receives: Drug: Nicotinamide
Placebo groupPlacebo comparatorSame 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in physical performance

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

    Measured: Four weeks

Secondary outcomes (6)

  1. Posturography

    Change Center of pressure (COP) between baseline and post-training in posturography

    Measured: Four weeks

  2. Dynamometry

    Change in dynamometry performance between baseline and post-training

    Measured: Four weeks

  3. Quadriceps saturation

    Change in quadriceps saturation after a 5-squat test

    Measured: Four weeks

  4. Adherence to medication

    Nicotinamide/placebo usage via self-report survey

    Measured: Four weeks

  5. Adverse effects

    Assessment of adverse effects using a standardized evaluation guideline.

    Measured: Four weeks

  6. Plasma sample analysis

    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)

    Measured: Four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start21 May 2024
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot randomized clinical trial, block allocation, double-blind
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06465602
Sponsor's protocol ID
FONDAP 15150012 GERO
Acronym
NICE-FIT
Status last verified
Apr 2024
First submitted
13 Jun 2024
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.

    PubMed 23523272

  • Tsao YL, Hsu CC, Chen KT. Blunt Traumatic Retropharyngeal Hematoma with Respiratory Symptoms: A Systematic Review of Reported Cases. Emerg Med Int. 2021 Oct 7;2021:5158403. doi: 10.1155/2021/5158403. eCollection 2021.

    PubMed 34659833

  • Hayes WC, Myers ER, Morris JN, Gerhart TN, Yett HS, Lipsitz LA. Impact near the hip dominates fracture risk in elderly nursing home residents who fall. Calcif Tissue Int. 1993 Mar;52(3):192-8. doi: 10.1007/BF00298717.

    PubMed 8481831

  • Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.

    PubMed 29512120

  • Loureiro V, Gomes M, Loureiro N, Aibar-Almazan A, Hita-Contreras F. Multifactorial Programs for Healthy Older Adults to Reduce Falls and Improve Physical Performance: Systematic Review. Int J Environ Res Public Health. 2021 Oct 15;18(20):10842. doi: 10.3390/ijerph182010842.

    PubMed 34682586

  • Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.

    PubMed 31171417

  • Rodrigues F, Domingos C, Monteiro D, Morouco P. A Review on Aging, Sarcopenia, Falls, and Resistance Training in Community-Dwelling Older Adults. Int J Environ Res Public Health. 2022 Jan 13;19(2):874. doi: 10.3390/ijerph19020874.

    PubMed 35055695

  • Sun M, Min L, Xu N, Huang L, Li X. The Effect of Exercise Intervention on Reducing the Fall Risk in Older Adults: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2021 Nov 29;18(23):12562. doi: 10.3390/ijerph182312562.

    PubMed 34886293

  • Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.

    PubMed 30703272

  • Chen Y, Zhang Y, Guo Z, Bao D, Zhou J. Comparison between the effects of exergame intervention and traditional physical training on improving balance and fall prevention in healthy older adults: a systematic review and meta-analysis. J Neuroeng Rehabil. 2021 Nov 24;18(1):164. doi: 10.1186/s12984-021-00917-0.

    PubMed 34819097

  • Adjetey C, Karnon B, Falck RS, Balasubramaniam H, Buschert K, Davis JC. Cost-effectiveness of exercise versus multimodal interventions that include exercise to prevent falls among community-dwelling older adults: A systematic review and meta-analysis. Maturitas. 2023 Mar;169:16-31. doi: 10.1016/j.maturitas.2022.12.003. Epub 2023 Jan 9.

    PubMed 36630860

  • Angulo J, El Assar M, Alvarez-Bustos A, Rodriguez-Manas L. Physical activity and exercise: Strategies to manage frailty. Redox Biol. 2020 Aug;35:101513. doi: 10.1016/j.redox.2020.101513. Epub 2020 Mar 20.

    PubMed 32234291

  • Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Izquierdo M. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial. J Appl Physiol (1985). 2017 Apr 1;122(4):985-996. doi: 10.1152/japplphysiol.01037.2016. Epub 2017 Feb 2.

    PubMed 28153946

  • Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3.

    PubMed 36599349

  • Covarrubias AJ, Perrone R, Grozio A, Verdin E. NAD+ metabolism and its roles in cellular processes during ageing. Nat Rev Mol Cell Biol. 2021 Feb;22(2):119-141. doi: 10.1038/s41580-020-00313-x. Epub 2020 Dec 22.

    PubMed 33353981

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nicotinamide in people with Frailty and Fall, run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Felipe H Salech Morales, MD PhD (229788546 ext. +56, fhsalech@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in physical performance (time frame: Four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06465602, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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