Gastrointestinal MicrobiomeNCT06181214
The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
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=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiome, Nutrition, Healthy, Healthy Aging
- What is being tested?
- AG1 - Nutritional Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 4 Oct 2023
- 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 50 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 50 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 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
- 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.
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- 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. 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 a negative pregnancy test prior to enrolling. 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.
- 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.
United States1 site
Center for Applied Health Sciences
Canfield, Ohio, 44046
About this study
This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.
- 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 | 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 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: 28 days
Secondary outcomes (6)
Complete Metabolic Blood Panel
Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine
Measured: 28 Days
Complete Blood Count
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
Measured: 28 Days
Exploratory nutrient status markers
Circulating concentrations of nutrient status (e.gg, zinc, vitamin c, folate, \& magnesium)
Measured: 28 days
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: 28 days
Exploratory Stool Consistency
Bristol Stool Scale (score 1-7) questionnaire that allows participants to identify how loose or hard their stool consistency is
Measured: 28 days
Exploratory Stool Frequency
100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start14 Aug 2023
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
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
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo Controlled Design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT06181214
- Sponsor's protocol ID
- AG-01-0623
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
La Monica MB, Raub B, Hartshorn S, Gustat AL, Grdic J, Kirby TO, Townsend JR, Sandrock J, Ziegenfuss TN. The effects of AG1(R) supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial. J Int Soc Sports Nutr. 2024 Dec;21(1):2409682. doi: 10.1080/15502783.2024.2409682. Epub 2024 Oct 1.
PubMed 39352252
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
- ClinicalTrials.gov ID
- NCT06181214
- Acronym / sponsor ID
- AG-01-0623
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Athletic Greens InternationalIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 26 Dec 2023 (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=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.
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 SupplementA foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between 18 and 50 yr (inclusive).
- Body Mass Index of 18.5-29.9 (inclusive).
- Body weight of at least 120 pounds.
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: 28 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
Complete Metabolic Blood Panel
Time frame: 28 Days
Complete Blood Count
Time frame: 28 Days
Exploratory nutrient status markers
Time frame: 28 days
Exploratory Digestive Measures
Time frame: 28 days
Exploratory Stool Consistency
Time frame: 28 days
Exploratory Stool Frequency
Time frame: 28 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 22 Mar 2024.
- Derived from this study: PubMed 39352252La Monica MB, Raub B, Hartshorn S, Gustat AL, Grdic J, Kirby TO, Townsend JR, Sandrock J, Ziegenfuss TN. The effects of AG1(R) supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial. J Int Soc Sports Nutr. 2024 Dec;21(1):2409682. doi: 10.1080/15502783.2024.2409682. Epub 2024 Oct 1.
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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.
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 10 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 22 Mar 2024. 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: 28 days). 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 NCT06181214, 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 22 Mar 2024.