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NCT Number: NCT07428889

Nicotinamide Adenine Dinucleotide Responses to a Nutritional Supplement

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.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location status: Recruiting

Location contact

Aditi Shah

PRINCIPAL_INVESTIGATOR

Biofortis Research Clinical Director

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Proprietary Nutritional Supplement

Dietary Supplement

1000 mg nicotinamide metabolites and plant extracts, taken orally, daily for 60 days

Placebo supplement

Dietary Supplement

1000 mg maltodextrin, taken orally, daily for 60 days

Primary outcomes

  1. Nicotinamide adenine dinucleotide response in whole blood

    Time frame: Baseline to Day 14

Secondary outcomes

  1. Nicotinamide adenine dinucleotide metabolite responses

    Time frame: Baseline to Days 1, 7, 14, and 30

  2. Subjective cognitive function visual analog scales

    Time frame: Baseline to Days 30 and 60

    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.

  3. Subjective quality of life questionnaire

    Time frame: Baseline to Days 30 and 60

    Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.

  4. Metabolic health markers

    Time frame: Baseline to Days 30 and 60

  5. Biological age

    Time frame: Baseline to Days 30 and 60

  6. Cardiorespiratory fitness

    Time frame: Baseline to Day 30 and 60

    Predicted VO2 max

  7. Physical function

    Time frame: Baseline to Days 30 and 60

    6 minute-walk test

  8. Subjective skin assessment questionnaire

    Time frame: Days 30 and 60

    Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.

Study contacts

Contact information is provided by the study sponsor or research team.

Biofortis Research Clinical Director Biofortis Research Clinical Director

CONTACT

[email protected]

(630) 617-2000

Sponsors and collaborators

Lead sponsor

Shaklee Corporation

Industry

Collaborators

  • Biofortis Clinical Research, Inc.
  • Nlumn LLC

Registry information

Official study title

A Randomized, Controlled, Pilot Trial to Assess the Effects of a Proprietary Nutritional Supplement on Nicotinamide Adenine Dinucleotide (NAD+) Responses in Healthy Adults

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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