Nutrition, HealthyNCT06332898
The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life
A study testing AG1 - Nutritional Supplement in people with Nutrition, Healthy and Gastrointestinal Microbiome, run by Athletic Greens International at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Gastrointestinal Microbiome, Healthy Aging
- What is being tested?
- AG1 - Nutritional Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2024to 4 Feb 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- AG1 - Nutritional Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG1 - Nutritional SupplementDietary supplement
A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
PlaceboDietary supplement
Maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin + Flavoring Receives: Dietary Supplement: Placebo |
| AG1 - Nutritional Supplement | Experimental | AG1, a foundational nutritional supplement Receives: Dietary Supplement: AG1 - Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homocysteine
Circulating Serum Homocysteine Concentrations (umol/L)
Measured: 90 days
Vitamin B12
Circulating Serum Vitamin B12 Concentrations (pg/mL)
Measured: 90 days
Folate
Circulating Serum Folate Concentrations (ng/mL)
Measured: 90 days
Red Blood Cell Folate
Circulating Red Blood Cell Folate Concentrations (nmol/L)
Measured: 90 days
Zinc
Circulating Serum Zinc Concentrations (ug/dL)
Measured: 90 days
Vitamin C
Serum Vitamin C Concentrations (
Measured: 90 days
Gut Microbiome
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.
Measured: 90 days
Secondary outcomes (6)
Dietary habits
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 90 Days
Gastrointestinal Health
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.
Measured: 90 Days
Fatigue & energy
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.
Measured: 90 Days
Well-being
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.
Measured: 90 Days
Complete Metabolic Blood Panel
Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine
Measured: 90 Days
Complete Blood Count
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start31 Mar 2024
- Primary completion31 Oct 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Model description
- Randomized, Double-Blind, Placebo Controlled Design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athletic Greens International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Ellen O'Gorman, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332898
- Sponsor's protocol ID
- AG-01-0324
- Status last verified
- May 2025
- First submitted
- 20 Mar 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life
- ClinicalTrials.gov ID
- NCT06332898
- Acronym / sponsor ID
- AG-01-0324
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Athletic Greens InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 27 Mar 2024 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo Controlled Design
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin + Flavoring |
| AG1 - Nutritional Supplement | Experimental | Dietary Supplement: AG1 - Nutritional SupplementAG1, a foundational nutritional supplement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| AG1 - Nutritional SupplementA foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients | Dietary supplement | AG1 - Nutritional Supplement |
| PlaceboMaltodextrin placebo | Dietary supplement | Placebo |
Primary outcome
Homocysteine
Time frame: 90 days
Circulating Serum Homocysteine Concentrations (umol/L)
Vitamin B12
Time frame: 90 days
Circulating Serum Vitamin B12 Concentrations (pg/mL)
Folate
Time frame: 90 days
Circulating Serum Folate Concentrations (ng/mL)
Red Blood Cell Folate
Time frame: 90 days
Circulating Red Blood Cell Folate Concentrations (nmol/L)
Zinc
Time frame: 90 days
Circulating Serum Zinc Concentrations (ug/dL)
Vitamin C
Time frame: 90 days
Serum Vitamin C Concentrations (
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.
6 secondary outcomes
Dietary habits
Time frame: 90 Days
Gastrointestinal Health
Time frame: 90 Days
Fatigue & energy
Time frame: 90 Days
Well-being
Time frame: 90 Days
Complete Metabolic Blood Panel
Time frame: 90 Days
Complete Blood Count
Time frame: 90 Days
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 4 May 2025.
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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.
Ellen O'Gorman principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AG1 - Nutritional Supplement in people with Nutrition, Healthy and Gastrointestinal Microbiome, 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 7 inclusion and 20 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?
Homocysteine (time frame: 90 days). The study lists 7 primary outcomes in all. 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 4 May 2025.