We often hear the myth that dietary supplements aren’t regulated—and that may leave you wondering if they are safe. While it’s always a good idea to questions a product’s safety, the truth is that health products do not exist in an unregulated “Wild West” environment.
The dietary supplements you find on store shelves and online are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act gives the Food and Drug Administration (FDA) the power to monitor the manufacturing of all dietary supplements.
Are Supplements, Including Aged Garlic Extract, Safe?
The FDA has established a set of rules and standards manufacturers must follow in order to qualify for GMP certification (Good Manufacturing Process). These quality control standards govern everything from raw materials to ingredient potency and accuracy to production to packaging and distribution. Annual audits are performed to ensure these standards are followed. If they are not met, the FDA has the power to recall products at any time. To ensure you’re getting a high-quality supplement, make sure the company is cGMP compliant. One example of this is Wakunaga of America, a well-respected manufacturer that was one of the first companies to receive certification as a GMP facility back in the 1980s.
In addition, both the Federal Trade Commission (FTC) and the FDA have enforcement programs designed to protect consumers from false or misleading claims about the safety and benefits of products marketed as dietary supplements. Both agencies have authority over how products are marketed. That said, it’s hard for these agencies to be everywhere all the time. This can leave some gaps in enforcement. If you come across products that make too-good-to-be-true claims, either on the label or in their promotional materials, you can make a consumer complaint to either agency.
Another way to ensure you’re getting a safe, high quality supplement that lives up to its claims is follow the science. One example of this is Kyolic Aged Garlic Extract (AGE), which has been the subject of more than over 1,000 published scientific articles. But, no matter what type of supplement you are considering, look closely at what the product or brand is claiming. If the supplement states that it is clinically studied or tested, it may be referring to general studies that were conducted on one or more of the ingredients in the product. It may also be referring to specific research done on a proprietary ingredient or ingredient blend from a competing product. This is especially rampant among online supplement sellers.
If you want to go to the next level of verification, check to see if the supplement has been researched using double-blind, randomized, placebo-controlled, and peer-reviewed. What about studies that are funded by the company that produces the product? If the studies have been published in peer-reviewed journals, the results are not prejudiced to the product. They are honest assessments of how a supplement, or the individual ingredients it contains, performs.
The Science Behind Aged Garlic Extract
With a growing body of peer-reviewed research into its safety and efficacy, Kyolic AGE has verifiable benefits supporting head-to-toe health. Here are just a handful of examples:
Aerobic Fitness. AGE was shown to provide long-term performance benefits for long distance athletes. In a double-blind, parallel, randomized study involving 75 middle-aged endurance athletes, AGE boosted VO2 max (the maximum amount of oxygen your body can utilize during intense exercise), increase arterial flexibility and aerobic power, decrease fatigue, and reduce post-workout recovery time. These benefits weren’t seen in those taking the placebo. The participants taking AGE also had a lower risk of cardiovascular disease compared to those in the placebo group.1
Blood Pressure. A study review conducted at the University of Adelaide, Australia, evaluated 12 clinical trials involving 553 patients with high blood pressure. The researchers found that taking 480 mg of AGE daily lowered systolic blood pressure (the top number) by an average of 8.3+1.9 mmHg and diastolic blood pressure (the bottom number) by 5.5+1.9 mmHg, results that are similar to standard blood pressure medications. This reduction was linked to a 16-40% drop in the risk of suffering from cardiovascular events. What’s more, those taking AGE for at least three months also experienced less arterial stiffness and an improvement in gut diversity and microbial richness, suggesting a more robust gut microbiome.2
Coronary Artery Calcification. The accumulation of calcium inside arteries stiffens blood vessels and signals underlying atherosclerotic plaque buildup. This significantly increases the risk of heart attacks and cardiovascular disease. A series of pooled randomized, double-blind, placebo-controlled trials from researchers at UCLA reported that patients taking 1,000 mg of AGE daily for one year experienced a significantly slower buildup of coronary artery calcification (CAC) compared to those taking a placebo.3 Another pilot study found that AGE provided incremental benefits even for high-risk patients already receiving statin therapy.4
Immunity. In a randomized, double-blind, placebo-controlled parallel-intervention study, 120 healthy adults took either 2.56 g of AGE or a placebo for 90 days during cold and flu season. At the end of the study, those in the AGE group who did get sick experienced fewer, less severe symptoms and fewer sick days.5 Another trial of 51 healthy obese participants found that taking a divided dose of 3.6 g of AGE for six weeks reduce inflammation and enhanced immunity. The researchers concluded that AGE, when taken consistently, might help to prevent chronic conditions linked to low-grade inflammation.6
Oral Health. Among 134 people with gingivitis, taking AGE daily effectively reduced gum inflammation and bleeding. Those taking a placebo didn’t experience these results. This trial, which was conducted at the Hebrew University-Hadassah School of Dental Medicine, was a randomized, controlled, examiner-blind, two treatment parallel group study that appeared in the Journal of Clinical Dentistry.7
Learn more about the science behind Kyolic Aged Garlic Extract.
FAQ’s about AGE safety
Are there any side effects?
Kyolic Aged Garlic Extract is safe to take and is generally well tolerated unless you are allergic or sensitive to garlic or any compounds in garlic.
How long until I see improvement?
As with any dietary supplement, results vary from individual to individual. We generally recommend taking the product for one to three months before evaluating.
Can you take this while pregnant?
The safety of our AGE has been confirmed in preclinical studies in each trimester of pregnancy. Although AGE has been successfully recommended for 60 years as an over-the-counter (OTC) for pregnant women in Japan, we always recommend that you consult with your healthcare provider before use.
Looking for more information about Aged Garlic Extract? We answer all of your pressing questions in our Ultimate Guide to Aged Garlic Extract.
Not all ‘aged garlic extract’ advertised in supplements is the same. This article focuses exclusively on research conducted using Wakunaga of America’s Kyolic Aged Garlic Extract. Wakunaga sources their garlic from organic farms in California and uses a proprietary process to create aged garlic. It then manufactures the aged garlic supplements in the USA in their own GMP certified facility with over 200 quality control checks from farm to bottle. Purity, potency and quality matter for herbal ingredients, and the health benefits of aged garlic extract can only be assured by using a well-researched product that meets the high standards of Kyolic.
References
- Ried K, Paye Y, Beale D, et al. Kyolic aged garlic extract improves aerobic fitness in middle‑aged recreational endurance athletes: A randomized double‑blind placebo‑controlled 3 month trial. Experimental and Therapeutic Medicine. 2025;29(4):86.
- Ried K. Garlic lowers blood pressure in hypertensive subjects, improves arterial stiffness and gut microbiota: A review and meta-analysis. Experimental and Therapeutic Medicine. 2020;19(2):1472-8.
- Hom C, Budoff M, Luo Y. The effects of aged garlic extract on coronary artery calcification progression and blood pressure. 2015;65(10S):A1472.
- Budoff M. Aged garlic extract retards progression of coronary artery calcification. Journal of Nutrition. 2006;136(3 Suppl):741S-4S.
- Percival SS. Aged garlic extract modifies human immunity. Journal of Nutrition. 2016;146(2):433S-6S.
- Xu C, Mathews AE, Rodrigues C, et al. Aged garlic extract supplementation modifies inflammation and immunity of adults with obesity: A randomized, double-blind, placebo-controlled clinical trial. Clinical Nutrition ESPEN. 2018;24:148-55.
- Zini A, Mann J, Mazor S, et al. The efficacy of aged garlic extract on gingivitis – a randomized clinical trial. Journal of Clinical Dentistry. 2018;29(2):52-6.
This article is for informational purposes only. This article is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment and should never be relied upon for specific medical advice.
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