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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05698771
Other study ID # 2023-496197
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 29, 2023
Est. completion date March 17, 2023

Study information

Verified date January 2023
Source Haukeland University Hospital
Contact Charalampos Tzoulis, MD, PhD
Phone 94392305
Email charalampos.tzoulis@uib.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the NAD-brain study is to determine the blood and brain pharmacokinetics of NAD replenishment therapy (NRT) using Nicotinamide Riboside (NR) or Nicotinamide Mononucleotide (NMN).


Description:

The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects. A total of 6-10 healthy individuals (3-5 men and 3-5 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites. The simultaneous change in NAD-metabolism over time in blood and brain will be assessed and blood and brain pharmacokinetics for NRT in humans will be established.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date March 17, 2023
Est. primary completion date March 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria: - Age 30-85 years at the time of enrollment. - Neurologically healthy at the time of enrollment. Exclusion Criteria: - History of acute or chronic neurological disorder affecting the central nervous system (CNS). Migraine, cluster headache, and tension headache are allowed, but not on the day of the study visits. - Impaired renal function. - Impaired hepatic function. - Severe hematological disease. - Any psychiatric disorder that would interfere with compliance in the study. - Any severe somatic illness that would make the individual unable to comply and participate in the study. - Mitochondrial disease. - Use of high dose vitamin B3 supplementation within 30 days of enrolment.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
nicotinamide riboside
The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects . A total of 6-10 healthy individuals (3-5 men and 3-5 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites using HPLC-MS. By this approach we will measure the simultaneous change in NAD-metabolism over time in blood and brain and establish blood and brain pharmacokinetics for NRT in humans. Based on these results we will determine the optimal dosing frequency of NRT in healthy individuals.
nicotinamide mononucleotide
The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects . A total of 6-10 healthy individuals (3-5 men and 3-5 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound. Blood will be analyzed for NAD-metabolites using HPLC-MS. By this approach we will measure the simultaneous change in NAD-metabolism over time in blood and brain and establish blood and brain pharmacokinetics for NRT in humans. Based on these results we will determine the optimal dosing frequency of NRT in healthy individuals.

Locations

Country Name City State
Norway Haukeland University Hospital Bergen Vestland

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary NAD metabolism The change of cerebral NAD levels (measured by 31P-MRS) and of blood NAD-metabolites (measured by HPLC-MS), over time (20 days), after the administration of oral NRT with the following NAD precursors: NR 600mg x 2 daily, NMN 600mg x 2 daily. 20 days for NR and 20 days for NMN
Secondary Interindividual differences Descriptive analyses of interindividual differences in the time course of change in the blood NAD-metabolome and cerebral NAD increase, following the administration of oral NRT. 20 days for NR and 20 days for NMN
Secondary Between-sex differences Between-sex differences in the time course of change in the blood NAD-metabolome and cerebral NAD increase, following the administration of oral NRT. 20 days for NR and 20 days for NMN
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