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Open-label Study to Assess Increasing Levels of NAD+(Nicotinamide Adenine Dinucleotide)

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ClinicalTrials.gov Identifier: NCT03707652
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.

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.

Condition or disease Intervention/treatment Phase
Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+) Dietary Supplement: Oral supplement A Dietary Supplement: Oral supplement B Dietary Supplement: Oral supplement C Dietary Supplement: Oral supplement D Dietary Supplement: Oral Supplement D in combination with oral supplement C Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Three-Day Dosing NAD + Study
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A (oral supplement A)-2 capsules
Oral supplement A (2 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement A
1, 2 or 4 capsules daily of oral supplement A for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort A (oral supplement B)-4 capsules
Oral supplement B (4 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement B
4 capsules daily of oral supplement B for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort A (oral supplement C)-2 capsules
Oral supplement C (2 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement C
1,2 or 4 capsules daily of oral supplement C for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort A (oral supplement A)-1 or 4 capsules
Oral supplement A (1 or 4 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement A
1, 2 or 4 capsules daily of oral supplement A for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort A (oral supplement D)-1 or 2 tablets
Oral supplement D (1 or 2 tablets) administered daily for 3 days
Dietary Supplement: Oral supplement D
1 or 2 tablets daily of oral supplement D for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort A (oral supplement D) or combination with supplement C
Oral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement D
1 or 2 tablets daily of oral supplement D for 3 days
Other Name: Vitamin B3 derivative

Dietary Supplement: Oral Supplement D in combination with oral supplement C
1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days

Experimental: Cohort B (oral supplement B)-4 capsules
Oral supplement B (4 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement B
4 capsules daily of oral supplement B for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort B (oral supplement C)-2 capsules
Oral supplement C (2 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement C
1,2 or 4 capsules daily of oral supplement C for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort B (oral supplement A)-2 capsules
Oral supplement A (2 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement A
1, 2 or 4 capsules daily of oral supplement A for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort B (oral supplement C)- 1 or 4 capsules
Oral supplement C (1 or 4 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement C
1,2 or 4 capsules daily of oral supplement C for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort B (oral supplement D)-1 or 2 tablets
Oral supplement D (1 or 2 tablets) administered daily for 3 days
Dietary Supplement: Oral supplement D
1 or 2 tablets daily of oral supplement D for 3 days
Other Name: Vitamin B3 derivative

Experimental: Cohort B(oral supplement D) or combination with supplement C
Oral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days
Dietary Supplement: Oral supplement D
1 or 2 tablets daily of oral supplement D for 3 days
Other Name: Vitamin B3 derivative

Dietary Supplement: Oral Supplement D in combination with oral supplement C
1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days




Primary Outcome Measures :
  1. Assess the mean change in NAD+ levels from baseline [ Time Frame: 63 days ]
    Mean change in NAD+ levels


Secondary Outcome Measures :
  1. Assess the mean change in AST (aspartate aminotransferase) levels from baseline [ Time Frame: 63 days ]
    Mean change in AST level

  2. Assess the mean change in ALT (alanine aminotransferase) levels from baseline [ Time Frame: 63 days ]
    Mean change in ALT level

  3. Assess the mean change in Total Cholesterol levels from baseline [ Time Frame: 63 days ]
    Mean change in Total Cholesterol level

  4. Assess the mean change in Triglycerides levels from baseline [ Time Frame: 63 days ]
    Mean change in Triglycerides level

  5. Assess the mean change in LDL Cholesterol levels from baseline [ Time Frame: 63 days ]
    Mean change in LDL Cholesterol level

  6. Assess the mean change in HDL Cholesterol levels from baseline [ Time Frame: 63 days ]
    Mean change in HDL Cholesterol level



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707652


Locations
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United States, Florida
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States, 33308
Sponsors and Collaborators
Supplement Formulators, Inc.
Investigators
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Principal Investigator: Andrew Swick, Ph.D LIfe Extension

Publications:
ClinicalTrials.gov. Effect of

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Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT03707652     History of Changes
Other Study ID Numbers: CL094
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamins
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents