Clinical trial NCT03707652: Open-label Study to Assess Increasing Levels of NAD+(Nicotinamide Adenine Dinucleotide)
Official title: Three-Day Dosing NAD + Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess an effective single oral supplement or combination of oral supplements for increasing whole blood NAD+ levels.

Detailed description: This is a open-label dose finding study to detect an effective single oral supplement or combination of oral supplements for enhancing whole blood levels of NAD+. Each subject will receive a specific dose of the formulation once daily for 3 days followed by a washout period. Upon completion of the treatment phase, there is a post-treatment period of assessments.

Participants receive assessments of blood tests, vital signs, body weight with completion of questionnaires.

The primary objective of the study is to identify the ideal dosage of an oral supplement to increase whole blood NAD+ levels in adults.

The secondary objective of the study is to monitor for safety from a change in fasting blood chemistry panel parameters after three day's dosing compared to cycle baseline.

Eligibility criteria: Inclusion Criteria:

* Able to provide written Informed Consent
* Able to follow verbal and written study directions in English
* Adult men and women between age 30-80 years (inclusive)
* Women of reproductive potential will practice contraception during the Investigation
* Body Mass Index (BMI) between 18.5 and 35 kg/m2
* Must not be taking or be willing to stop taking any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
* Must not be using or be willing to stop use of any "100%" or higher niacin fortified foods from seven days prior to screening visit and for the duration of the investigation
* Able to maintain consistent diet and lifestyle habits throughout the study
* Volunteers with chronic but stable and well controlled medical conditions (i.e., hypertension controlled by a consistent dose of medication for a minimum of six months; chronic use of consistent dose of blood-thinning medication; diet-controlled Type II diabetes) may participate at the discretion of the PI or Sub-I.
* Willing and able to provide fasting blood samples
* Able to attend scheduled visits at the Life Extension Clinical Research (LECR) facility

Exclusion Criteria:

* Current use of prescription or over-the-counter nicotinic acid
* Use of statin drugs
* Having used any tobacco product or used a recreational drug in the past 6 months
* Medically complicated \[i.e., diabetes requiring insulin; uncontrolled hypertension (blood pressure readings at screening/baseline \> 140 systolic or \> 90 diastolic on two consecutive readings); etc.\] at the discretion of the PI or Sub-I
* Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the PI or Sub-I
* Woman who is pregnant, nursing, or planning a pregnancy. Non-pregnant status of women of childbearing potential will be confirmed during each Day 3 Cycle LECR visit (Wednesday or Thursday) via serum pregnancy test.
* Currently, or within the past 30 days, enrolled in a different clinical investigation
* Inability to provide a venous blood sample
* Unable to refrain from any alcohol consumption for the duration of the study
* Unable or unwilling to provide written informed consent for participation in study

Primary outcomes:
measure: Assess the mean change in NAD+ levels from baseline
timeFrame: 63 days
Secondary outcomes:
measure: Assess the mean change in AST (aspartate aminotransferase) levels from baseline
timeFrame: 63 days
measure: Assess the mean change in ALT (alanine aminotransferase) levels from baseline
timeFrame: 63 days
measure: Assess the mean change in Total Cholesterol levels from baseline
timeFrame: 63 days
measure: Assess the mean change in Triglycerides levels from baseline
timeFrame: 63 days
measure: Assess the mean change in LDL Cholesterol levels from baseline
timeFrame: 63 days
measure: Assess the mean change in HDL Cholesterol levels from baseline
timeFrame: 63 days
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Life Extension Clinical Research, Inc.
state: Florida
Study officials:
affiliation: LIfe Extension
name: Andrew Swick, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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