AgingNCT04276948
Effects of NAD3 Supplementation on Biomarkers of Aging
A study testing NAD3 in people with Aging, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial summary
This is a randomized, parallel-group, placebo-controlled, clinical trial in middle-aged and older male and female subjects from Ohio. Subjects will take an over-the-counter dietary supplement or a placebo for 12 weeks. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- NAD3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history, physical, and routine blood chemistries.
- Age between the ages of 40 and 60 (inclusive).
- Body Mass Index (BMI) of 18.5-34.9 kg/m2 (normal to Class I obesity).
- Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal supine, resting heart rate (<90 per minute).
- Willing to duplicate their previous 24-hour diet, and fast for 10 hours prior each of the treatments.
Who cannot join
- History of uncontrolled diabetes.
- Regular use/consumption (i.e. at least 5 days/week) of resveratrol, quercetin, pterostilbene coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber, green tea, niacin (vitamin B3), multivitamin/multimineral or products meant to promote "healthy aging" or "anti-aging" or "longevity" products in the 2 weeks prior to screening as well as throughout the study.
- Clinically significant abnormal blood work at screening.
- Consumption of > 2 alcoholic drinks per day.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
Show all 14Show fewer
- Chronic inflammatory condition/disease or unstable medical condition (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, hepatitis, HIV/AIDS, etc.).
- Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- History of drug or alcohol addiction or abuse within 1 year prior to screening.
- Treatment with any known enzyme-altering drugs such as barbiturates, glucocorticoids, macrolides, antidepressants, neuroleptics, imidazoles, or fluoroquinolones within 30 days prior to screening.
- Subjects who (for whatever reason) have been on a self-restricted diet, controlled diet or special therapeutic diet, or who have had substantial changes in eating habits within 30 days prior to screening.
- Donation of blood within 30 days or plasma within 7 days, prior to screening.
- History or presence of clinically significant diseases or conditions (e.g., cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric) which, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: Effects of NAD3 Supplementation on Biomarkers of Anti-Aging in Healthy Men and Women
This is a randomized, parallel-group, placebo-controlled, clinical trial in middle-aged and older male and female subjects from Ohio. Subjects will take an over-the-counter dietary supplement or a placebo for 12 weeks. Outcome measures will include body weight, systolic and diastolic blood pressure, standard blood chemistries (e.g. chemistry panel, lipid panel, CBC with differential), changes in mood, vitality, energy, fatigue, productivity, digestive wellness (via anchored Visual Analogue Scales).
- Conditions
- Aging
- Being tested
- NAD3
- Keywords
- dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAD3Dietary supplement
NAD3 is an over-the-counter dietary supplement available online to consumers.
| Study group | Role | What they receive |
|---|---|---|
| Active1 | Experimental | 312 mg dose of active Receives: Dietary Supplement: NAD3 |
| Active2 | Experimental | 812 mg dose of active Receives: Dietary Supplement: NAD3 |
| Placebo | Placebo comparator | placebo Receives: Dietary Supplement: NAD3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in pounds
Measured: baseline
body weight
body weight in pounds
Measured: week 4
body weight
body weight in pounds
Measured: week 8
body weight
body weight in pounds
Measured: week 12
blood pressure
systolic and diastolic blood pressure in mm Hg
Measured: baseline
blood pressure
systolic and diastolic blood pressure in mm Hg
Measured: week 4
blood pressure
systolic and diastolic blood pressure in mm Hg
Measured: week 8
blood pressure
systolic and diastolic blood pressure in mm Hg
Measured: week 12
blood lipids
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
Measured: baseline
blood lipids
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
Measured: week 4
blood lipids
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
Measured: week 8
blood lipids
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
Measured: week 12
Secondary outcomes (12)
mood
subjective measurement of mood (number rating from Likert style scale questionnaire)
Measured: baseline
mood
subjective measurement of mood (number rating from Likert style scale questionnaire)
Measured: week 4
mood
subjective measurement of mood (number rating from Likert style scale questionnaire)
Measured: week 8
mood
subjective measurement of mood (number rating from Likert style scale questionnaire)
Measured: week 12
vitality
subjective measurement of vitality (number rating from Likert style scale questionnaire)
Measured: baseline
vitality
subjective measurement of vitality (number rating from Likert style scale questionnaire)
Measured: week 4
vitality
subjective measurement of vitality (number rating from Likert style scale questionnaire)
Measured: week 8
vitality
subjective measurement of vitality (number rating from Likert style scale questionnaire)
Measured: week 12
energy
subjective measurement of energy (number rating from Likert style scale questionnaire)
Measured: baseline
energy
subjective measurement of energy (number rating from Likert style scale questionnaire)
Measured: week 4
energy
subjective measurement of energy (number rating from Likert style scale questionnaire)
Measured: week 8
energy
subjective measurement of energy (number rating from Likert style scale questionnaire)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start8 Jun 2020
- Primary completion29 Jan 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276948
- Sponsor's protocol ID
- CS-01-2020
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NAD3 Supplementation on Biomarkers of Anti-Aging in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT04276948
- Acronym / sponsor ID
- CS-01-2020
- Conditions
- Aging
- Keywords
- dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, parallel-group, placebo-controlled, clinical trial in middle-aged and older male and female subjects from Ohio. Subjects will take an over-the-counter dietary supplement or a placebo for 12 weeks. Outcome measures will include body weight, systolic and diastolic blood pressure, standard blood chemistries (e.g. chemistry panel, lipid panel, CBC with differential), changes in mood, vitality, energy, fatigue, productivity, digestive wellness (via anchored Visual Analogue Scales).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active1 | Experimental | Dietary Supplement: NAD3312 mg dose of active |
| Active2 | Experimental | Dietary Supplement: NAD3812 mg dose of active |
| Placebo | Placebo comparator | Dietary Supplement: NAD3placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history, physical, and routine blood chemistries.
- Age between the ages of 40 and 60 (inclusive).
- Body Mass Index (BMI) of 18.5-34.9 kg/m2 (normal to Class I obesity).
- Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
Key exclusion criteria (14 listed)
- History of uncontrolled diabetes.
- Regular use/consumption (i.e. at least 5 days/week) of resveratrol, quercetin, pterostilbene coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber, green tea, niacin (vitamin B3), multivitamin/multimineral or products meant to promote "healthy aging" or "anti-aging" or "longevity" products in the 2 weeks prior to screening as well as throughout the study.
- Clinically significant abnormal blood work at screening.
- Consumption of > 2 alcoholic drinks per day.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAD3NAD3 is an over-the-counter dietary supplement available online to consumers. | Dietary supplement | Active1, Active2, Placebo |
Primary outcome
body weight
Time frame: baseline
body weight in pounds
body weight
Time frame: week 4
body weight in pounds
body weight
Time frame: week 8
body weight in pounds
body weight
Time frame: week 12
body weight in pounds
blood pressure
Time frame: baseline
systolic and diastolic blood pressure in mm Hg
blood pressure
Time frame: week 4
systolic and diastolic blood pressure in mm Hg
blood pressure
Time frame: week 8
systolic and diastolic blood pressure in mm Hg
blood pressure
Time frame: week 12
systolic and diastolic blood pressure in mm Hg
blood lipids
Time frame: baseline
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
blood lipids
Time frame: week 4
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
blood lipids
Time frame: week 8
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
blood lipids
Time frame: week 12
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
12 secondary outcomes
mood
Time frame: baseline
mood
Time frame: week 4
mood
Time frame: week 8
mood
Time frame: week 12
vitality
Time frame: baseline
vitality
Time frame: week 4
vitality
Time frame: week 8
vitality
Time frame: week 12
energy
Time frame: baseline
energy
Time frame: week 4
energy
Time frame: week 8
energy
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAD3 in people with Aging, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.