RECRUITING

Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the subjective effects of injection administration of NR on healthy adult populations.

Official Title

Absorption and Tolerability of Injectable Administration of Niagen®+, Nicotinamide Riboside Chloride, a Specialized Form of Vitamin B3, as Compared to NAD+: a Double Blinded, Randomized, Controlled Clinical Trial

Quick Facts

Study Start:2024-10-31

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06919328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form * Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study * Lives within 100 miles of the NRI study site * Any gender, aged 40-65, inclusive * Good general health as evidenced by medical history * BMI 25-34.9 kg/m2 * Sedentary behavior (defined as \<20 minutes per day or 100 minutes per week of moderate to vigorous exercise) * Demonstrated fatigue (Fatigue Assessment Scale) defined as a below-average score * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study * Agreement to adhere to Lifestyle Considerations throughout study duration	* Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease * ANY chronic illness (pre-disease state acceptable) * Out of range phosphate levels at baseline * BMI less than 25 or greater than or equal to 35 * Pregnancy, trying to conceive, or breastfeeding * Known allergic reactions to any components of the intervention or related compounds, including any form of B3 * Positive COVID-19 test within 30 days of the study period * Recent dramatic weight changes (10% change in body weight in the last 6 months) * Existing usage of a NAD+ or NAD precursor supplement in any form (oral, nasal, patch, or injection/IV administration), including a B-complex supplement, within 60 days of the study, not including multivitamins. * Introducing a new medication, supplement, investigational drug, or other intervention (including lifestyle changes) within 60 days of the start of the study.

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
* Lives within 100 miles of the NRI study site
* Any gender, aged 40-65, inclusive
* Good general health as evidenced by medical history
* BMI 25-34.9 kg/m2
* Sedentary behavior (defined as \<20 minutes per day or 100 minutes per week of moderate to vigorous exercise)
* Demonstrated fatigue (Fatigue Assessment Scale) defined as a below-average score
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
* Agreement to adhere to Lifestyle Considerations throughout study duration

* Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease
* ANY chronic illness (pre-disease state acceptable)
* Out of range phosphate levels at baseline
* BMI less than 25 or greater than or equal to 35
* Pregnancy, trying to conceive, or breastfeeding
* Known allergic reactions to any components of the intervention or related compounds, including any form of B3
* Positive COVID-19 test within 30 days of the study period
* Recent dramatic weight changes (10% change in body weight in the last 6 months)
* Existing usage of a NAD+ or NAD precursor supplement in any form (oral, nasal, patch, or injection/IV administration), including a B-complex supplement, within 60 days of the study, not including multivitamins.
* Introducing a new medication, supplement, investigational drug, or other intervention (including lifestyle changes) within 60 days of the start of the study.

Contacts and Locations

Study Contact

JESSIE HAWKINS, PhD

CONTACT

2562039010

j.hawkins@nutraceuticalsresearch.com

Study Locations (Sites)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801

United States

Collaborators and Investigators

Sponsor: Nutraceuticals Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

NAD+

Additional Relevant MeSH Terms

Healthy Aging