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

24 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment AG1 - Nutritional Supplement, Athletic Greens, AG1 Greens for gastrointestinal issues?

Research shows that a combination of artichoke and ginger extracts can help manage gastrointestinal discomfort, which suggests that similar ingredients in AG1 might also be beneficial for such issues. ^{1 2 3 4 5}

Is the nutritional supplement AG1 generally safe for human use?

The safety of dietary supplements like AG1 is generally assured by compliance with regulations, but serious adverse events (SAEs) have been reported, mostly with weight loss and glycemic control products. Green tea extracts, a common ingredient, have been linked to liver damage when consumed on an empty stomach, but are considered safe when used properly with cautionary labeling. ^{6 7 8 9 10}

How does AG1 - Nutritional Supplement differ from other treatments for gastrointestinal issues?

AG1 - Nutritional Supplement, also known as Athletic Greens, is unique because it combines a variety of botanical ingredients like turmeric and ashwagandha, which are not typically found in standard treatments for gastrointestinal issues. This supplement is designed to support overall health and wellness, which may indirectly benefit gastrointestinal health, unlike traditional treatments that focus solely on symptom relief. ^{9 11 12 13 14}

What is the purpose of this trial?

This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

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 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 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]

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]

References

1. Switzerland 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal problems as a function of carbohydrate supplements and mode of exercise. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of artichoke and ginger extracts with simethicone to treat gastrointestinal symptoms in endurance athletes: a pilot study. [2023]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

FUNCTIONAL FOODS ARE CRITICAL COMPONENTS OF TREATMENT OF METABOLIC DISORDERS IN CELIAC DISEASE. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

An Exploratory Study Investigating the Prevalence of Gastrointestinal Symptoms in Collegiate Division I American Football Athletes. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of green tea extracts : a systematic review by the US Pharmacopeia. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Dietary Supplements: Knowledge and Adverse Event Reporting Among American Medical Society for Sports Medicine Physicians. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Athletes Perceived Level of Risk Associated with Botanical Food Supplement Use and Their Sources of Information. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Dietary supplementation practices in Canadian high-performance athletes. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Self-Reported Use and Reasons among the General Population for Using Sports Nutrition Products and Dietary Supplements. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Nutritional Supplement Use and Athletic Characteristics among a Sample of NCAA Division I and Division III Student-Athletes. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Nutritional Supplement Habits of Athletes With an Impairment and Their Sources of Information. [2018]