Gastrointestinal MicrobiomeNCT06521424
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
A study testing AG1 - Nutritional Supplement in people with Gastrointestinal Microbiome and Nutrition, Healthy, 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=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiome, Nutrition, Healthy, Exercise
- What is being tested?
- AG1 - Nutritional Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Dec 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 40 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.
- > 1 year of resistance training experience (minimum of 2 days per week of resistance training session with free weights)
- Age between 18 and 40 yr (inclusive).
- 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
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- History of diabetes or endocrine disorder.
- History of use of medications 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 or smoking within the past month.
- History of hyperparathyroidism or an untreated thyroid condition.
Show all 15Show fewer
- 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, Irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastro paresis, 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 become pregnant, women less than 120 days postpartum or nursing women.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized, double-blind, placebo-controlled study of N=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.
- Conditions
- Gastrointestinal Microbiome, Nutrition, Healthy, Exercise
- Being tested
- AG1 - Nutritional Supplement, Placebo
- Medical subject headings
- Motor Activity
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 | A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients Receives: Dietary Supplement: AG1 - Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome
Examine changes in the gut microbiome via fecal polar metabolomics measured by LC/MS
Measured: 14 days
Nutrient Gaps
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
Measured: 14 days
Secondary outcomes (1)
Exploratory Digestive Measures
A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MicrobiomeStudies 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
- Crossover
- Model description
- Randomized, Double-Blind, Placebo Controlled Design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athletic Greens International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521424
- Sponsor's protocol ID
- AG-01-0722
- Status last verified
- May 2025
- First submitted
- 22 Jul 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gonzalez AM, Townsend JR, Sapp PA, Edwards C, Kirby TO, Wright J, Lamendella R, Esposito R. Effect of AG1(R) supplementation on nutritional adequacy and gut microbial composition in trained adults. Front Nutr. 2026 Mar 31;13:1783951. doi: 10.3389/fnut.2026.1783951. eCollection 2026.
PubMed 41988471
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 Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
- ClinicalTrials.gov ID
- NCT06521424
- Acronym / sponsor ID
- AG-01-0722
- Conditions
- Gastrointestinal Microbiome, Nutrition, Healthy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Athletic Greens InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jul 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=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 SupplementA foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- > 1 year of resistance training experience (minimum of 2 days per week of resistance training session with free weights)
- Age between 18 and 40 yr (inclusive).
- Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
Key exclusion criteria (15 listed)
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- History of diabetes or endocrine disorder.
- History of use of medications 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 or smoking within the past month.
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
Gut Microbiome
Time frame: 14 days
Examine changes in the gut microbiome via fecal polar metabolomics measured by LC/MS
Nutrient Gaps
Time frame: 14 days
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
1 secondary outcome
Exploratory Digestive Measures
Time frame: 14 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.
- Derived from this study: PubMed 41988471Gonzalez AM, Townsend JR, Sapp PA, Edwards C, Kirby TO, Wright J, Lamendella R, Esposito R. Effect of AG1(R) supplementation on nutritional adequacy and gut microbial composition in trained adults. Front Nutr. 2026 Mar 31;13:1783951. doi: 10.3389/fnut.2026.1783951. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gastrointestinal Microbiome
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastrointestinal Microbiome and Nutrition, Healthy, 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 6 inclusion and 15 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?
Gut Microbiome (time frame: 14 days). The study lists 2 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 NCT06521424, 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.