Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls
NCT ID: NCT06465602
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-05-21
2025-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Nicotinamide
The subjects will receive 1.5 grams per day of Nicotinamide, orally, for 30 days.
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.
Placebo
The subjects will receive 1.5 grams per day of placebo, orally, for 30 days.
Interventions
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Nicotinamide
The subjects will receive 1.5 grams per day of Nicotinamide, orally, for 30 days.
Placebo
The subjects will receive 1.5 grams per day of placebo, orally, for 30 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Motor sequelae of stroke
* Joint pathology with severe pain preventing strength exercises
* Cognitive impairment that renders the informed consent process impossible.
65 Years
ALL
No
Sponsors
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Centro FONDAP de Gerociencia, Salud mental y Metabolismo (GERO)
UNKNOWN
Center for Advanced Clinical Research (CICA ) - University of Chile
UNKNOWN
University of Chile
OTHER
Responsible Party
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Principal Investigators
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Felipe H Salech Morales, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chile
Locations
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Hospital Clínico Universidad de Chile
Santiago, , Chile
Countries
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Central Contacts
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Facility Contacts
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Felipe Salech, MD PhD
Role: primary
References
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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.
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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.
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.
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.
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.
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.
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Hwang ES, Song SB. Possible Adverse Effects of High-Dose Nicotinamide: Mechanisms and Safety Assessment. Biomolecules. 2020 Apr 29;10(5):687. doi: 10.3390/biom10050687.
Knip M, Douek IF, Moore WP, Gillmor HA, McLean AE, Bingley PJ, Gale EA; European Nicotinamide Diabetes Intervention Trial Group. Safety of high-dose nicotinamide: a review. Diabetologia. 2000 Nov;43(11):1337-45. doi: 10.1007/s001250051536.
Preyat N, Rossi M, Kers J, Chen L, Bertin J, Gough PJ, Le Moine A, Rongvaux A, Van Gool F, Leo O. Intracellular nicotinamide adenine dinucleotide promotes TNF-induced necroptosis in a sirtuin-dependent manner. Cell Death Differ. 2016 Jan;23(1):29-40. doi: 10.1038/cdd.2015.60. Epub 2015 May 22.
Other Identifiers
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FONDAP 15150012 GERO
Identifier Type: -
Identifier Source: org_study_id
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