Nutritional Supplement for Gastrointestinal Issues

Overseen By Ellen O'Gorman

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Athletic Greens International

Must not be taking: Opioids, Gut supplements

Disqualifiers: Chronic illness, Extreme diets, Pregnancy, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new nutritional supplement, AG1 - Nutritional Supplement (also known as Athletic Greens or AG1 Greens), might assist individuals with occasional stomach issues. Researchers aim to determine if this supplement can improve gut health, fill nutrition gaps, and be easily tolerated. The trial will compare the supplement to a placebo, a harmless pill with no active ingredients. Individuals who sometimes experience stomach pain, bloating, or heartburn after meals might be suitable candidates for this trial. Participants must be in good health and maintain their current diet and lifestyle throughout the study. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of AG1 for gut health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications or supplements that target gut health or nutritional gaps, as well as any medications that can affect the gastrointestinal tract. The trial requires that you have not taken such products in the past 30 days and do not plan to introduce them during the study.

Is there any evidence suggesting that AG1 - Nutritional Supplement is likely to be safe for humans?

Research shows that AG1, the nutritional supplement under study, is safe for use. Studies have found that healthy adults can take AG1 safely for up to four weeks. These studies also suggest that AG1 might help with digestive issues. Additionally, NSF International has certified AG1, confirming it contains no banned substances. While these results are encouraging, they primarily focus on short-term use. More research is needed to understand its long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about AG1, a new nutritional supplement for gastrointestinal issues, because it combines a variety of beneficial components like vitamins, minerals, probiotics, and prebiotics with whole food ingredients. Unlike many current treatments that might focus on a single nutrient or probiotic strain, AG1 offers a comprehensive approach, potentially enhancing digestive health through multiple pathways. This holistic composition aims to support gut health more effectively, offering a promising alternative to traditional treatments that often involve pharmaceuticals or singular dietary adjustments.

What evidence suggests that this nutritional supplement could be effective for gastrointestinal issues?

This trial will compare AG1, a nutritional supplement, with a placebo to evaluate its effects on digestive health. Studies have shown that AG1 might enhance digestive well-being. Specifically, after four weeks of taking AG1, participants in those studies noticed possible improvements in their digestive health. The supplement also increased the amount of good bacteria in the gut, aiding digestion. Importantly, AG1 did not alter stool consistency, indicating it was generally well-tolerated. While changes in gut bacteria were observed, reports did not clearly indicate improved digestion. Overall, AG1 may offer some digestive benefits, but individual results might vary. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adult men and women who sometimes have gastrointestinal issues. It's designed to see if a new dietary supplement can help with nutrient deficiencies and gut health.

Inclusion Criteria

Body Mass Index of 20-34.9

Agree to maintain existing dietary and physical activity patterns throughout the study period

Willing and able to comply with the study protocol

Exclusion Criteria

I am currently taking opioid medications like oxycodone or morphine.

Current smokers or smoking within the past month

I do not have chronic health issues that could affect my study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a novel dietary supplement or placebo to assess effects on gut microbiome, nutrient gaps, and tolerability

2 weeks

1 visit (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AG1 - Nutritional Supplement

Trial Overview The study tests a nutritional supplement called AG1 against a placebo, which has no active ingredients. Participants won't know which one they're taking. The goal is to see if AG1 improves GI symptoms and the gut microbiome.

How Is the Trial Designed?

Group I: AG1 - Nutritional Supplement Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin + Flavoring

AG1 - Nutritional Supplement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Athletic Greens for:

• General health and wellness
• Nutritional support

Approved in European Union as AG1 Greens for:

• General health and wellness
• Nutritional support

Approved in Canada as Athletic Greens for:

• General health and wellness
• Nutritional support

Who Is Running the Clinical Trial?

Athletic Greens International

Lead Sponsor

Trials

5

Recruited

230+

Published Research Related to This Trial

A study of 440 high-performance Canadian athletes revealed that 87% reported taking three or more dietary supplements in the past six months, with sports drinks and protein powders being the most common.

Despite a high awareness of anti-doping regulations, the study suggests that current sources of supplementation advice may not be credible, indicating a need for sports medicine professionals to enhance their role in guiding athletes' supplementation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplementation practices in Canadian high-performance athletes. Lun, V., Erdman, KA., Fung, TS., et al.[2022]

A pilot study involving 50 endurance athletes found that a combination of artichoke leaves and ginger root extracts with simethicone significantly reduced exercise-related gastrointestinal symptoms, with upper GI symptoms decreasing by 86.6% and lower GI symptoms by 85.9%.

The most notable improvements were in lower GI issues, such as flatulence and intestinal cramps, indicating that this combination may effectively alleviate digestive discomfort during endurance activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of artichoke and ginger extracts with simethicone to treat gastrointestinal symptoms in endurance athletes: a pilot study. Drobnic, F., Fonts, S., García-Alday, I., et al.[2023]

A systematic review of 1,204 participants found that pre-, pro-, and syn-biotic supplements did not significantly improve gastrointestinal permeability or symptoms at rest or during exercise, indicating limited efficacy for these interventions.

While prebiotic supplementation increased certain beneficial gut bacteria and short-chain fatty acids, probiotics mainly boosted the specific strains given without affecting overall gastrointestinal health markers, suggesting a need for more comprehensive studies with validated biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prebiotics, probiotics, and synbiotics on gastrointestinal outcomes in healthy adults and active adults at rest and in response to exercise-A systematic literature review. Rauch, CE., Mika, AS., McCubbin, AJ., et al.[2022]

In a study involving 32 male triathletes, gastrointestinal (GI) symptoms were found to last longer with a fluid placebo compared to a semisolid carbohydrate supplement, indicating that the type of supplement can influence GI discomfort during exercise.

GI symptoms were more frequent and severe during running compared to cycling, and factors such as energy depletion and carbohydrate malabsorption were significantly related to the occurrence of these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal problems as a function of carbohydrate supplements and mode of exercise. Peters, HP., van Schelven, FW., Verstappen, PA., et al.[2022]

In a study of 20 celiac disease patients, the use of Native-complex Fucus jelly over 2 months significantly improved stool consistency and frequency, with 70% of patients achieving daily bowel movements by the end of the study.

The functional food also positively impacted gut microbiota, correcting dysbiosis and enhancing intestinal health, which is often compromised in patients following a long-term gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FUNCTIONAL FOODS ARE CRITICAL COMPONENTS OF TREATMENT OF METABOLIC DISORDERS IN CELIAC DISEASE. Tkachenko, EI., Oreshko, LS., Sitkin, SI., et al.[2018]

A survey of 247 NCAA student-athletes revealed that all athletes, regardless of whether they were in Division I or Division III, commonly used nutritional supplements, highlighting a widespread practice among college athletes.

Despite differences in demographics and access to sports dietitians, no specific demographic or athletic characteristics significantly influenced the overall usage of supplements, suggesting a need for improved education and resources on supplement safety for all student-athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Supplement Use and Athletic Characteristics among a Sample of NCAA Division I and Division III Student-Athletes. Hamilton, KP., Ziegler, J., Samavat, H., et al.[2023]

A survey of 217 athletes in Ireland revealed that while 60% reported using general food supplements, only 16% used botanical food supplements (BFSs), with turmeric/curcumin, Ashwagandha, and Beetroot extract being the most popular.

Amateur athletes were more likely to seek information about BFSs from less credible sources, such as fellow athletes or the internet, which may lead to a lower perception of risks and increase their chances of doping violations or adverse health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Athletes Perceived Level of Risk Associated with Botanical Food Supplement Use and Their Sources of Information. McDaid, B., Wardenaar, FC., Woodside, JV., et al.[2023]

58% of athletes with impairments reported using nutritional supplements in the past 6 months, with elite athletes being more likely to use them, possibly due to higher training demands and access to nutritionists.

Despite the popularity of supplements like protein and multivitamins, 9% of users experienced negative effects, highlighting the need for better education on proper dosage and reliable sources of information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Supplement Habits of Athletes With an Impairment and Their Sources of Information. Graham-Paulson, TS., Perret, C., Smith, B., et al.[2018]

Out of 41,121 reported adverse events related to dietary supplements, only 203 (0.48%) were classified as serious adverse events (SAEs), indicating a low incidence of serious issues among users.

The majority of SAEs were linked to weight loss (69.0%) and glycemic control (19.2%) supplements, with cardiovascular, gastrointestinal, and nervous system disorders being the most affected organ systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience. Schmitz, SM., Lopez, HL., Mackay, D., et al.[2020]

A significant 62% of a representative sample of 1544 Dutch individuals reported using dietary supplements (DS) or sport nutrition products (SNPs) in the past year, with women and older adults showing the highest usage of DS.

Health benefits were the primary motivation for using DS (90%), while performance enhancement was a key reason for SNP use (35%), raising questions about the appropriateness of SNPs for less active individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Reported Use and Reasons among the General Population for Using Sports Nutrition Products and Dietary Supplements. Wardenaar, F., van den Dool, R., Ceelen, I., et al.[2020]

A systematic review of 216 case reports on green tea products revealed 34 instances of liver damage, with 27 categorized as possible and 7 as probable causality, raising safety concerns about concentrated green tea extracts.

The review indicated that taking green tea extracts on an empty stomach increases the risk of adverse effects, but when used appropriately, these products can be considered safe for development into official monographs, provided they include cautionary labeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of green tea extracts : a systematic review by the US Pharmacopeia. Sarma, DN., Barrett, ML., Chavez, ML., et al.[2021]

A survey of 311 military and civilian sports medicine physicians revealed that while 71% had encountered adverse events from dietary supplements (DSs), only 10% reported these events, highlighting a significant gap in reporting practices.

Many physicians lack reliable sources of information on DS safety (51%) and do not routinely discuss DS use with patients (58%), indicating a need for better education on the importance of reporting adverse events and the processes involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Supplements: Knowledge and Adverse Event Reporting Among American Medical Society for Sports Medicine Physicians. Pascale, B., Steele, C., Attipoe, S., et al.[2016]

A study analyzing 110 reports of adverse reactions to herbal dietary supplements in Italy found that 23 serious reactions occurred, with 21 requiring hospitalization, highlighting significant safety concerns regarding these products.

Dermatological and cardiovascular issues were the most common reactions, and 9 out of 10 serious hepatic reactions were reported, indicating that the quality and supervision of these supplements are critical for consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. Ippoliti, I., Menniti-Ippolito, F., Mazzanti, G., et al.[2021]

In a study of 44 collegiate American football athletes, 52% reported experiencing gastrointestinal (GI) complaints during exercise, highlighting the prevalence of GI symptoms in this population.

Athletes who used protein supplements had significantly higher GI symptom scores compared to those who did not, suggesting a potential link between protein supplement use and increased GI issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Study Investigating the Prevalence of Gastrointestinal Symptoms in Collegiate Division I American Football Athletes. Wardenaar, FC., Schott, KD., Mohr, AE., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11445888/

The effects of AG1® supplementation on the gut ... AG1R can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality of life.

2. drinkag1.com drinkag1.com/learn/research/scientific-research

AG1® | Research Studies After four weeks, AG1® enriched beneficial probiotic taxa, showed a potential improvement in digestive quality of life, and did not negatively impact stool ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39352252/

a randomized, double-blind, placebo-controlled clinical trial Conclusions: AG1R can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality ...

4. drinkag1.com drinkag1.com/en-eu/learn/research/scientific-research

The Science Behind AG1 | Research & Formulation After four weeks, AG1® enriched beneficial probiotic taxa, showed a potential improvement in digestive quality of life, and did not negatively impact stool ...

5. examine.com examine.com/research-feed/study/dZXLM0/?requirelogin=1&srsltid=AfmBOoqiceGk7FOxcXKxTpkIEcJ7Spz1sWdxTdx7gZYZmPrKbYe1J-6F

The effect of a popular green powder supplement on ... In this randomized controlled trial, the green powder supplement AG1 altered the participants' gut microbiome but did not clearly improve self-reported ...

6. vively.co.uk vively.co.uk/post/is-ag1-and-athletic-greens-actually-healthy

Is AG1 and Athletic Greens actually healthy? - Vively The authors concluded AG1 is safe and “can be consumed…over four weeks with a potential beneficial impact on their digestive symptom quality of ...

7. drinkag1.com drinkag1.com/product

AG1® | Product Detail AG1 is certified for quality and safety by NSF International and is NSF Certified for Sport® meaning it does not contain any of the 270+ substances banned by ...