Inflammation in COPD and the Effect of Nicotinamide Riboside

NCT04990869 | Completed

• 1 other identifier: NR-COPD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate if nicotinamide riboside can reduce the airways inflammation associated with chronic obstructive pulmonary disease (COPD) in patients aged 60 or older. A major event in aging is the loss of the central metabolite nicotinamide adenine dinucleotide (NAD+) that appear to be important in the proinflammatory environment that occur during aging. Notably, recent work suggest that aging can be ameliorated by even a short-term treatment of the NAD+ precursor nicotinamide riboside. Nicotinamide riboside has recently been shown to be able to return aging tissues to a younger state even after short term treatment. This vitamin B3- analog is naturally occurring, is readily taken up through oral administration and has been tested in human trials with few side effects. The investigators hypothesize that six weeks of nicotinamide riboside supplementation reduces interleukin-8 measured in sputum from COPD patients. Further, it is hypothesized that augmentation of NAD+ in COPD patients might alleviate symptoms through activation of sirtuins.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Interleukin-8

  Measured in sputum

  6 weeks

Secondary Outcomes (6)

• NAD+ levels

  6 weeks

• Interleukin-6

  6 weeks

• Interleukin-10

  6 weeks

• Tumor necrosis factor alpha

  6 weeks

• C-reactive protein

  6 weeks

Other Outcomes (3)

• Untargeted metabolomics

  6 weeks

• Untargeted RNA sequencing

  6 weeks

• DNA methylation

  6 weeks

Study Arms (4)

COPD-NR

EXPERIMENTAL

COPD patients receiving Nicotinamide Riboside

Dietary Supplement: Nicotinamide Riboside

COPD-placebo

PLACEBO COMPARATOR

COPD patients receiving placebo

Dietary Supplement: Placebo

Control-NR

EXPERIMENTAL

Lung-healthy controls receiving Nicotinamide Riboside

Dietary Supplement: Nicotinamide Riboside

Control-placebo

PLACEBO COMPARATOR

Lung-healthy controls receiving placebo

Dietary Supplement: Placebo

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

The patients will receive 1 g of Nicotinamide Riboside or placebo orally every morning and evening for 6 weeks.

COPD-NR; Control-NR

Placebo DIETARY_SUPPLEMENT

Placebo

COPD-placebo; Control-placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Age 60 or older.
• A body mass index (BMI) between 18.5-40.0 kg·m-2 and a weight ≥ 40 kg at enrolment.
• A diagnosis of chronic obstructive pulmonary disease (FEV1/FVC \< 0.7).
• Smoking history of at least 10 pack years, but currently ex-smoker.
• Not using any inhalation steroids.
• A worsening of symptoms in relation to respiratory infections.

You may not qualify if:

• Exacerbation of COPD or severe airway infection within the last two months.
• Chronic use of supplements containing vitamin B or NR.
• Planned surgery during the course of the trial.
• Dementia/cognitive impairment or symptomatic psychiatric illness.
• Cancer diagnosis within last 5 years.
• Inability to speak and read Danish.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Concurrent enrollment in another clinical study involving an investigational treatment.
• Written informed consent.
• Age-, sex- and BMI-matched with COPD patients.
• No history of lung disease.
• Never-smoker.
• Chronic use of supplements containing vitamin B or NR.
• Planned surgery during the course of the trial.
• Dementia/cognitive impairment or symptomatic psychiatric illness.

Sponsors & Collaborators

• University of Copenhagen: lead
• Bispebjerg Hospital: collaborator
• Elysium Health: collaborator

Study Sites (1)

Respiratory Research Unit, Bispebjerg Hospital

Copenhagen, Denmark

Location

Related Publications (1)

• Norheim KL, Ben Ezra M, Heckenbach I, Andreasson LM, Eriksen LL, Dyhre-Petersen N, Damgaard MV, Berglind M, Pricolo L, Sampson D, Dellinger RW, Sverrild A, Treebak JT, Ditlev SB, Porsbjerg C, Scheibye-Knudsen M. Effect of nicotinamide riboside on airway inflammation in COPD: a randomized, placebo-controlled trial. Nat Aging. 2024 Dec;4(12):1772-1781. doi: 10.1038/s43587-024-00758-1. Epub 2024 Nov 15.

  PMID: 39548320 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Morten Scheibye-Knudsen, MD/DMSc(PhD)

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 5, 2021
• Study Start: August 5, 2021
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

DK (1)