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

NCT06316700 | Completed

• 1 other identifier: AG-02-0124
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (4)

• Plasma concentration of zinc following consumption of study products

  Zinc (ug/dl)

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

• Plasma concentration of Vitamin C following consumption of study products

  Vitamin C (mg/dl)

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

• Plasma concentration of Folate following consumption of study products

  Folate (ng/ml)

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

• Plasma concentration of calcium following consumption of study products

  Calcium (mg/dl)

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

Study Arms (2)

Nutritional Powder Supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Nutritional supplement

Placebo

PLACEBO COMPARATOR

Maltodextrin + Flavoring

Dietary Supplement: Placebo

Interventions

Nutritional supplement DIETARY_SUPPLEMENT

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

Nutritional Powder Supplement

Placebo DIETARY_SUPPLEMENT

Maltodextrin placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Athletic Greens International: lead

Study Sites (1)

Center for Applied Health Sciences

Canfield, Ohio, 44046, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: October 1, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)