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Healthy AgingNCT06316700

A Pharmacokinetic Study of a Novel Nutritional Product on Healthy Men and Women

A study testing Nutritional supplement in people with Healthy Aging, run by Athletic Greens International at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, double-blind, placebo-controlled study of N=16 apparently healthy men and women. The purpose of this study is to examine the bioavailability of a health and wellness supplement. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging
What is being tested?
Nutritional supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Apr 2024to 1 Oct 2024
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 18 to 45 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 and routine blood chemistries.
  • Age between 18 and 45 yr (inclusive).
  • Body Mass Index of 18.5-29.9 (inclusive).
  • Body weight of at least 120 pounds.
  • Normotensive (seated, 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.
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  • Normal seated, resting heart rate (<90 per minute).
  • Willing to duplicate and record their previous 24-hour diet, refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit.
  • Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
  • Subject is willing and able to comply with the study protocol.

Who cannot join

  • Multivitamin/Multimineral supplement consumption within the past 3 months
  • Additionally, eligible participants cannot regularly consume (i.e., at least five days/week) 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 months prior to screening as well as throughout the study.
  • Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 3 months prior to study entry.
  • History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
  • History of diabetes or endocrine disorder.
  • History of use of medications (e.g., Retinoids, levodopa, statins, loop diuretics) or dietary supplements known to confound the study or its endpoints.
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  • Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
  • Current smokers, vapers, or tobacco users or use of tobacco within the past month.
  • History of hyperparathyroidism or an untreated thyroid condition.
  • History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
  • Prior gastrointestinal bypass surgery (Lapband), etc.
  • Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, Inflammatory bowel syndrome (IBS), Inflammatory bowel disease (IBD; e.g., Crohn's, ulcerative colitis), diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
  • Chronic inflammatory condition (e.g., rheumatoid arthritis, , Lupus, HIV/AIDS, etc.).
  • Previous medical diagnosis of asthma, gout, or fibromyalgia.
  • Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take pregnancy test prior to enrolling with a negative result. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
  • A change in hormone therapy, including oral contraceptives, within 4 weeks prior to screening, or unwilling to maintain current hormone therapy/oral contraceptive use throughout the course of the study.
  • Known sensitivity to any ingredient in the test formulations as listed in the product label.
  • Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
  • Any other conditions that, 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.
  • Subject is engaged in a specialty diet including but not limited to, Vegan, Vegetarian, Ketogenic, Paleo, Atkins, South Beach, Carnivore, etc.
  • Subjects that have donated blood or plasma within the previous week.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Applied Health Sciences

    Canfield, Ohio, 44046

Other trials in United States

About this study

This study is a randomized, double-blind, placebo-controlled study of N=16 apparently healthy men and women. The purpose of this study is to examine the bioavailability of a health and wellness supplement.

Conditions
Healthy Aging
Being tested
Nutritional supplement, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional supplementDietary supplement

    A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

  • PlaceboDietary supplement

    Maltodextrin placebo

Study groups in NCT06316700
Study groupRoleWhat they receive
Nutritional Powder SupplementActive comparatorA foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
Receives: Dietary Supplement: Nutritional supplement
PlaceboPlacebo comparatorMaltodextrin + Flavoring
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentration of zinc following consumption of study products

    Zinc (ug/dl)

    Measured: Baseline & 30, 60, 90, 120, 180, 240, 360, 480 minutes post-ingestion

  2. Plasma concentration of Vitamin C following consumption of study products

    Vitamin C (mg/dl)

    Measured: Baseline & 30, 60, 90, 120, 180, 240, 360, 480 minutes post-ingestion

  3. Plasma concentration of Folate following consumption of study products

    Folate (ng/ml)

    Measured: Baseline & 30, 60, 90, 120, 180, 240, 360, 480 minutes post-ingestion

  4. Plasma concentration of calcium following consumption of study products

    Calcium (mg/dl)

    Measured: Baseline & 30, 60, 90, 120, 180, 240, 360, 480 minutes post-ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion31 Jul 2024
  4. Study completion1 Oct 2024

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316700
Sponsor's protocol ID
AG-02-0124
Status last verified
May 2025
First submitted
21 Feb 2024
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sapp PA, Townsend JR, Kirby TO, Edwards CG, La Monica MB, Ziegenfuss TN, Vergne MJ, Akers WS, Esposito R. Absorption kinetics of vitamins and minerals from a novel nutritional product in physically active adults: a randomized, double-blind, placebo-controlled crossover trial. Front Nutr. 2026 Jul 6;13:1793264. doi: 10.3389/fnut.2026.1793264. eCollection 2026.

    PubMed 42518997

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional supplement in people with Healthy Aging, run by Athletic Greens International 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 10 inclusion and 21 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 4 May 2025. 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?

Plasma concentration of zinc following consumption of study products (time frame: Baseline & 30, 60, 90, 120, 180, 240, 360, 480 minutes post-ingestion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316700, which also lists 1 linked publication.

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 4 May 2025.

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