This study explores vitamin B3, Nicotinamide Riboside (NR), which has the potential to improve physical and cognitive function in older adults.

Aging is associated with a loss of physical and cognitive function, which affects the quality of life for individuals, their relatives, and society. Furthermore, the prevalence of dementia increases among individuals with age-related functional decline.

The results of this study will provide a better understanding of how NR affects the body’s and brain’s functions and metabolism. The project has the potential to offer new insights into whether and how NR can mitigate age-related functional decline. If proven effective, NR could provide a new, non-invasive treatment method to improve the quality of life for a broad population of older adults.

In the study, participants will be randomized to take a high dose of vitamin B3 in the form of NR or a placebo (sugar pill). Vitamin B3/NR is classified as a dietary supplement by the Norwegian Medicines Agency. The substance has no known toxic or harmful effects, and no significant side effects are expected. The medication is taken orally in tablet form.

There are several inclusion criteria, including being 75 years or older. An overall assessment of physical performance, functional decline, and possible weight loss will determine eligibility. This assessment will be made during the screening visit.

All participants in the study will receive either the study medication in the form of Nicotinamide Riboside (NR) at a dose of 2000 mg daily or a placebo (tablet with no active ingredient, just starch) for 52 weeks. The study medication is in tablet form and should be taken daily. Neither you nor your study doctor will know whether you are receiving NR or placebo until the study is completed. After the study ends, we will compare the results between those who received NR and those who received a placebo. This will allow us to distinguish between a real biological effect of vitamin B3 and a perceived effect, known as the placebo effect.

Before starting the study, one of the study doctors will invite you to a physical visit called a screening assessment. During this visit, we will ask about your medical history, medications you use, and conduct a thorough physical examination. At this screening visit, we will explain what the study involves and determine if you meet the criteria to participate. If you meet the criteria, is motivated to participate, and consent to participation, you will be invited to the first study visit.

Study Location:
The study is both led and conducted by Neuro-SysMed, a neurological research group at Haukeland University Hospital. Throughout the study, you will attend follow-up visits at the hospital in weeks 1, 26, and 52, with consultations lasting between 60 and 180 minutes.

Tests and Examinations:
Before the first visit, you will wear a portable watch for one week. This watch will monitor movements, potential falls, and general activity levels. You will also receive a sensor to place near your bed to record sleep patterns at home. You will be referred for a hearing test and radiological examinations. MRI imaging of the brain and FDG-PET scans will be conducted before or in connection with the first and last study visit. FDG-PET is an examination using radioactive tracers to visualize brain structures and activity; this examination is only for the first participants in the study.

Study visits will include medical examinations, various tests, cognitive assessments, and questionnaires on symptoms and quality of life. We will also take blood samples to ensure the study medication’s safety and research blood samples to investigate its effects on various blood markers.

In weeks 12 and 40, we will call you to check on your status and record any side effects. During these phone follow-ups, you will also need to provide blood samples.

The study is approved by the Regional Ethics Committee (REK No. 680827) and the Norwegian Medicines Agency.