120 Participants NeededMy employer runs this trial

Nutritional Supplement for Nutrient Gaps and Gut Health

EO
JN
Overseen ByJodi Nicolli
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Athletic Greens International
Must be taking: GLP-1 medications

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how the new nutritional supplement AG1 can fill nutrient gaps and improve gut health for individuals using GLP-1 medications, such as Ozempic or Trulicity, often prescribed for weight management or diabetes care. The study compares the effects of AG1 to a placebo (a substance with no active ingredient) to determine its effectiveness. It suits generally healthy adults who have maintained a stable dose of a GLP-1 medication for at least eight weeks and do not have ongoing digestive or metabolic issues. Participants must maintain their usual diet and lifestyle throughout the study. As an unphased trial, this study provides a unique opportunity to contribute to understanding AG1's potential benefits for enhancing gut health.

Will I have to stop taking my current medications?

You can continue taking your current GLP-1 medication at your maintenance dose, but you must avoid starting any new supplements, medications, or herbal remedies during the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have shown that AG1, a nutritional supplement, is safe for healthy adults. Research indicates that people who took AG1 for four weeks did not report any safety problems. Another study found that AG1 could be taken safely and even improved participants' digestive health. These findings suggest that AG1 is generally well-tolerated, with no major side effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about AG1, a nutritional supplement, because it aims to address nutrient gaps and improve gut health in a unique way. Unlike traditional treatments for nutrient deficiencies that often target specific vitamins or minerals individually, AG1 combines a wide range of nutrients into a single supplement, potentially offering a more comprehensive solution. This all-in-one approach could simplify the supplementation process and improve adherence, making it a promising option for individuals looking to enhance their overall nutritional intake and gut health. Additionally, the potential improvement in gut health might offer benefits beyond traditional nutrient supplementation, addressing both deficiencies and digestive wellbeing simultaneously.

What evidence suggests that this nutritional supplement could be effective for nutrient gaps and gut health?

Research has shown that AG1, a nutritional supplement tested in this trial, can help fill common nutrient gaps by improving the balance of vitamins and minerals in the body. Studies have found that AG1 aids in nutrient absorption and supports gut health by increasing beneficial bacteria in the digestive system. In one study, participants taking AG1 reported better digestion and an improved quality of life. Another study found that AG1 significantly improved the intake of nutrients often lacking in diets. Overall, AG1 shows promise in boosting both nutrient levels and gut health. Participants in this trial will receive either AG1 or a placebo to further evaluate these effects.12456

Are You a Good Fit for This Trial?

This trial is for adults aged 18-59 in the US with a BMI between 20 and 31.9 who are already taking GLP-1 medications at a stable dose. Participants must be generally healthy, not pregnant or breastfeeding, willing to keep their diet and habits unchanged, and avoid other supplements or certain medications.

Inclusion Criteria

Willing to avoid introducing other supplements, medications, or herbal remedies
Generally healthy without diagnosed uncontrolled chronic disease
Has access to a consistent weighing scale
See 6 more

Exclusion Criteria

Regularly consumed products targeting specific health areas within the past 2 months
I have a metabolic health condition like high blood pressure or high cholesterol.
I have been diagnosed with Type I or Type II diabetes.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the AG1 nutritional supplement or placebo to evaluate its impact on nutrient gaps and gut health

12 weeks
Regular visits for assessments

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 randomly assigns participants to receive either AG1 nutritional supplement or a placebo. It aims to see if AG1 can improve nutrient levels and gut health in people using GLP-1 medications. Neither participants nor researchers know which group anyone is in (triple-blind).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dietary Supplement: AG1 - Nutritional SupplementExperimental Treatment1 Intervention
Group II: Dietary Supplement: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Athletic Greens International

Lead Sponsor

Trials
5
Recruited
230+

Citations

Effect of AG1® supplementation on nutritional adequacy and ...

Conclusions. Two weeks of AG1® supplementation improved micronutrient adequacy in healthy resistance-trained adults by reducing nutrient gaps. Supplementation ...

The effects of AG1® supplementation on the gut microbiome ...

AG1R can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality of life.

AG1® | Research Studies

At a high-level, AG1 Next Gen was clinically shown to close common nutrient gaps—areas where the average diet may fall short—and support gut health, two ...

The Effects of a Nutritional Supplement on Nutrient Status ...

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 ...

AG1® Supplementation Improves Gut Microbiome ...

This study assessed individual needs and experiences with PN to inform strategies for dietitians to address gaps and advance health outcomes. Methods: U.S. ...

Learn what a nutritional gap is, why most Americans face ...

A nutrient gap is the discrepancy between the levels of nutrients the average person obtains from their diet and the levels of nutrients recommended to ...