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OpenTrials
Completed

NCT Number: NCT06332898

The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life

This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provide voluntary signed and dated informed consent.
  • No known history of chronic illness or disease.
  • Aged between 18 and 59.9 years (inclusive).
  • Body Mass Index of 20-34.9 (inclusive).
  • Willing to duplicate their previous 24-hour diet, refrain from caffeine and exercise for 24 hours, and fast for 10 hours prior to each Quest visit.
  • Agree to maintain existing dietary and physical activity patterns throughout the study period.
  • Willing and able to comply with the study protocol.

Exclusion criteria

  • History of unstable or new-onset cardiovascular, liver, or renal conditions.
  • History of diabetes or endocrine disorder.
  • Multivitamin/Multimineral supplement consumption within the past 3 months.
  • Regular consumption (i.e., at least five days/week) of resveratrol, quercetin, pterostilbene, coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber, green tea, niacin (vitamin B3), or products meant to promote "healthy aging" or "anti-aging" or "longevity" 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 90 days prior to study.
  • History of use of medications or dietary supplements known to confound the study or its endpoints.
  • Excessive 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 or smoking 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, IBS/IBD, diarrheal illnesses, history of colon resection, gastroparesis, Inborn errors of metabolism (such as PKU).
  • Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
  • Previous medical diagnosis of asthma, gout, or fibromyalgia.
  • Pregnant women, women trying to conceive, women less than 120 days postpartum, or nursing women.
  • 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 allergy or 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.

>10% weight change in the last 6 months.

  • Specific exclusion type diets like vegan, vegetarian, carnivore, paleo, atkins, ketogenic etc.

Treatment and study plan

AG1 - Nutritional Supplement

Dietary Supplement

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

Placebo

Dietary Supplement

Maltodextrin placebo

Primary outcomes

  1. Homocysteine

    Time frame: 90 days

    Circulating Serum Homocysteine Concentrations (umol/L)

  2. Vitamin B12

    Time frame: 90 days

    Circulating Serum Vitamin B12 Concentrations (pg/mL)

  3. Folate

    Time frame: 90 days

    Circulating Serum Folate Concentrations (ng/mL)

  4. Red Blood Cell Folate

    Time frame: 90 days

    Circulating Red Blood Cell Folate Concentrations (nmol/L)

  5. Zinc

    Time frame: 90 days

    Circulating Serum Zinc Concentrations (ug/dL)

  6. Vitamin C

    Time frame: 90 days

    Serum Vitamin C Concentrations (

  7. Gut Microbiome

    Time frame: 90 days

    Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.

Secondary outcomes

  1. Dietary habits

    Time frame: 90 Days

    Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool

  2. Gastrointestinal Health

    Time frame: 90 Days

    Gastrointestinal symptom rating scale (GSRS). Symptom score change after 90 days of administration, compared to Baseline. Score base on a 1-7 scale with a higher score meaning a worse outcome.

  3. Fatigue & energy

    Time frame: 90 Days

    Multidimensional Fatigue Inventory (MFI).The MFI is a 20-item instrument consisting of several subscales including general fatigue and reduced activity and will be assessed after 90 days of administration compared to baseline.

  4. Well-being

    Time frame: 90 Days

    World Health Organization-5 Well-being Index Questionnaire.The World Health Organization-5 Well-Being Index is a brief scale, composed of five questions in which the participants indicate in each one of them, based on the last two weeks, the frequency of their sensations, being 0 (at no time) and 5 (all of the time). The result is given as the sum of the numbers of each statement, with values ranging from 0, which represents the worst possible quality of life and 25, which is associated with the best possible quality of life. Will be assessed at baseline and after 90 days of administration.

  5. Complete Metabolic Blood Panel

    Time frame: 90 Days

    Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine

  6. Complete Blood Count

    Time frame: 90 Days

    Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit

Sponsors and collaborators

Lead sponsor

Athletic Greens International

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
May 4, 2025

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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