Healthy AdultNCT07428889
Nicotinamide Adenine Dinucleotide Responses to a Nutritional Supplement
A study testing Proprietary Nutritional Supplement in people with Healthy Adult, run by Shaklee Corporation at 1 site in United States.
Trial summary
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Proprietary Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 5 Apr 2026
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, ≥45 to ≤65 years of age
- BMI ≥18.5 and <30.0 kg/m2
- Ambulatory and currently free of injury or other physical impairment that hinders mobility.
- Willing to use personal smart phone with operating system (Android version 12.0 or newer; iOS version 16 or newer).
- Willingness to maintain current skin care regimen and avoid any skin-related medical procedures.
- Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Who cannot join
- Is currently following, or planning to be on, a weight loss regimen.
- Weight loss or gain >4.5 kg.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
- History of neurologic disorder that could produce cognitive deterioration.
- History of bouts of delirium, confusion, repeated minor head injury or a single injury.
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- History of unconventional sleep patterns or a diagnosed sleep disorder.
- History of any infective or inflammatory brain disease.
- Use of tobacco/nicotine products.
- Use of hemp/marijuana products.
- Unstable use of any prescription medication.
- Unstable use (initiation or change in dose) of hormonal contraceptives or therapy.
- Use of any dietary supplements (orally or infused), other than a conventional once daily multi-vitamin.
- Use of medication(s) or dietary supplement(s) known to affect absorption.
- Recent history of or strong potential for alcohol or substance abuse.
- Exposed to any non-registered drug product.
- A score of <7 on the Vein Access Scale Assessment.
- History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders.
- Uncontrolled hypertension.
- Known allergy to any ingredients contained in the study product.
- Any signs or symptoms of active infection of clinical relevance.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- History of any major trauma or major surgical event.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use of sex hormones for contraception.
- An employee or representative who has a financial interest in Sponsor organization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Randomized, Controlled, Pilot Trial to Assess the Effects of a Proprietary Nutritional Supplement on Nicotinamide Adenine Dinucleotide (NAD+) Responses in Healthy Adults
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.
Read the detailed description
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+), its metabolites, and markers of health in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.
- Conditions
- Healthy Adult
- Being tested
- Proprietary Nutritional Supplement, Placebo Supplement
- Keywords
- NAD+ metabolism, Markers of health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Nutritional SupplementDietary supplement
1000 mg nicotinamide metabolites and plant extracts, taken orally, daily for 60 days
Placebo SupplementDietary supplement
1000 mg maltodextrin, taken orally, daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Proprietary nutritional supplement | Experimental | Participants will take the experimental supplement orally, daily. Receives: Dietary Supplement: Proprietary Nutritional Supplement |
| Placebo supplement | Placebo comparator | Participants will take the placebo supplement orally, daily. Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotinamide adenine dinucleotide response in whole blood
Measured: Baseline to Day 14
Secondary outcomes (8)
Nicotinamide adenine dinucleotide metabolite responses
Measured: Baseline to Days 1, 7, 14, and 30
Subjective cognitive function visual analog scales
Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.
Measured: Baseline to Days 30 and 60
Subjective quality of life questionnaire
Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.
Measured: Baseline to Days 30 and 60
Metabolic health markers
Measured: Baseline to Days 30 and 60
Biological age
Measured: Baseline to Days 30 and 60
Cardiorespiratory fitness
Predicted VO2 max
Measured: Baseline to Day 30 and 60
Physical function
6 minute-walk test
Measured: Baseline to Days 30 and 60
Subjective skin assessment questionnaire
Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.
Measured: Days 30 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start17 Feb 2026
- Primary completion5 Apr 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaklee Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Nlumn LLC
- Responsible party
- Sponsor
- Investigators
- Erin Barrett, PhD, Study director, Shaklee Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428889
- Sponsor's protocol ID
- BIO-2601
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Pilot Trial to Assess the Effects of a Proprietary Nutritional Supplement on Nicotinamide Adenine Dinucleotide (NAD+) Responses in Healthy Adults
- ClinicalTrials.gov ID
- NCT07428889
- Acronym / sponsor ID
- BIO-2601
- Conditions
- Healthy Adult
- Keywords
- NAD+ metabolism, Markers of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shaklee CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Nlumn LLC
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 24 Feb 2026 (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.
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.
Detailed description
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+), its metabolites, and markers of health in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprietary nutritional supplement | Experimental | Dietary Supplement: Proprietary Nutritional SupplementParticipants will take the experimental supplement orally, daily. |
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo SupplementParticipants will take the placebo supplement orally, daily. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, ≥45 to ≤65 years of age
- BMI ≥18.5 and <30.0 kg/m2
- Ambulatory and currently free of injury or other physical impairment that hinders mobility.
- Willing to use personal smart phone with operating system (Android version 12.0 or newer; iOS version 16 or newer).
- Willingness to maintain current skin care regimen and avoid any skin-related medical procedures.
Key exclusion criteria (25 listed)
- Is currently following, or planning to be on, a weight loss regimen.
- Weight loss or gain >4.5 kg.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
- History of neurologic disorder that could produce cognitive deterioration.
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 |
|---|---|---|
| Proprietary Nutritional Supplement1000 mg nicotinamide metabolites and plant extracts, taken orally, daily for 60 days | Dietary supplement | Proprietary nutritional supplement |
| Placebo Supplement1000 mg maltodextrin, taken orally, daily for 60 days | Dietary supplement | Placebo supplement |
Primary outcome
Nicotinamide adenine dinucleotide response in whole blood
Time frame: Baseline to Day 14
8 secondary outcomes
Nicotinamide adenine dinucleotide metabolite responses
Time frame: Baseline to Days 1, 7, 14, and 30
Subjective cognitive function visual analog scales
Time frame: Baseline to Days 30 and 60
Subjective quality of life questionnaire
Time frame: Baseline to Days 30 and 60
Metabolic health markers
Time frame: Baseline to Days 30 and 60
Biological age
Time frame: Baseline to Days 30 and 60
Cardiorespiratory fitness
Time frame: Baseline to Day 30 and 60
Physical function
Time frame: Baseline to Days 30 and 60
Subjective skin assessment questionnaire
Time frame: Days 30 and 60
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Erin Barrett, PhD study director
Shaklee Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary Nutritional Supplement in people with Healthy Adult, run by Shaklee Corporation 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 6 inclusion and 25 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 6 Aug 2026. 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?
Nicotinamide adenine dinucleotide response in whole blood (time frame: Baseline to Day 14). 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 6 Aug 2026.