What “Clinically Studied” Really Means in Supplements

IntroductionWhen you pick up a supplement bottle, one of the first things you might see is a phrase like “clinically studied”, “science-backed”, or “proven to support…”. These phrases feel reassuring. They feel like science.

But what do they actually mean?

Unfortunately, in the supplement world, these terms are often used more for marketing than for genuine scientific clarity. This post will help you understand what “clinically studied” really means, how evidence is evaluated in Europe and the United States, and how to separate meaningful scientific findings from marketing language.

Dietary Supplements: What They Are (and Aren’t)

First, we have to anchor on the official definition of a dietary supplement.

In the United States, dietary supplements are legally defined as products intended to supplement the diet that contain one or more nutrients or ingredients like vitamins, minerals, herbs, amino acids, or botanical extracts. They are designed to add to what you get from regular food, not replace a healthy diet. Unlike medicines, supplements are not subject to the same rigorous safety and efficacy testing before they come to market. (Wikipedia)

In the European Union, supplements (often labelled “food supplements”) are concentrated sources of nutrients like vitamins, minerals, essential amino acids, and botanicals intended to supplement the normal diet. They can only be labelled as such and must not claim to prevent or cure disease. (European Food Safety Authority)

Key implication: just because something is “clinically studied” does not mean it has been proven to work for a health outcome that matters to you.

In short

Dietary supplements are legally classified as foods, not medicines.

·       In the EU, they are regulated as food supplements

·       In the US, they fall under DSHEA (1994)

·       They do not require pre-market proof of effectiveness

·       They cannot legally claim to treat or cure disease

This regulatory reality matters because it explains why phrases like “clinically studied” exist at all—they fill the credibility gap without requiring proof of outcomes.

What “Clinically Studied” Should Mean

A product claiming to be “clinically studied” should ideally meet the following scientific criteria:

1. Human Evidence

   
   

   The study must involve human participants — not lab dishes, animals, or simulated models.

2. Relevant Ingredient and Dose

   
   

   The study must test the exact ingredient and dose found in the product on the label, not a similar compound or unrelated amount.

3. Strong Study Design

   
   

   The research should be randomised and controlled — meaning participants are randomly assigned to supplement versus placebo, and outcomes are measured systematically.

4. Peer-Reviewed Publication

   
   

   Results should be published in reputable scientific journals where other scientists evaluate the methodology and findings.

Without these elements, a study cannot meaningfully support claims that a supplement works in people.

What counts as “peer-reviewed” (and what doesn’t)

A source generally qualifies as peer-reviewed if it is:

• Published in a scholarly journal (e.g., via PubMed-indexed titles)

• Reviewed by independent experts before publication

• Provides enough methodological detail to evaluate bias, statistics, and reproducibility

Typically not peer-reviewed:

• Brand blogs/marketing pages, media releases, magazines, social posts

• “White papers” hosted by a company (unless also published in a journal)

• Testimonials and influencer content

The below table of Evidence is on the ingredients that are found in our Brand Serenova

Evidence table (human clinical trials)

Ingredient	Human study design (peer-reviewed)	Participants	Dose & duration	Outcomes observed	Marketing-compliant claim language (ingredient-level)
Ashwagandha (Withania somnifera) extract	Randomised, double-blind, placebo-controlled trial	60 stressed, healthy adults	240 mg/day; 60 days	Reduced anxiety score (HAM-A) and reduced morning cortisol vs placebo	“In a randomised, placebo-controlled human trial, ashwagandha extract was associated with reduced stress/anxiety scores and lower morning cortisol.”
Maca (Lepidium meyenii)	Randomised, double-blind, placebo-controlled crossovertrial	14 postmenopausal women	3.5 g/day; 6 weeks (then crossover)	Reduced psychological symptom scores (incl. anxiety/depression subscales) and reduced sexual dysfunction measures vs placebo	“In a controlled human trial in postmenopausal women, macaintake was associated with improvements in psychological symptom scores (including anxiety and depression subscales).”
L-theanine	Randomised controlled trial	30 healthy adults	(Trial reports 4-week administration); 200 mg/day is commonly cited for this study context	Improved stress-related symptom measures and improved sleep quality indices (PSQI) vs placebo condition	“In a randomised human trial, L-theanine was associated with improvements in stress-related measures and sleep quality indices.”
Lion’s Mane (Hericium erinaceus)	Double-blind, placebo-controlled clinical trial	Adults aged 50–80 with mild cognitive impairment (MCI)	Tablets (dry powder), 16 weeks	Improved cognitive function scale scores during intake; effects diminished after stopping	“In a placebo-controlled human trial in older adults with MCI, lion’s mane intake was associated with improved cognitive test scores during supplementation.”
Green tea extract (EGCG)	Randomised, double-blind, placebo-controlled trial	102 women with central obesity	EGCG 856.8 mg/day; 12 weeks	Statistically significant reductions in weight, BMI, and waist circumference vs placebo	“In a randomised, placebo-controlled human trial, high-EGCG green tea extract was associated with modest reductions in weight and waist measurements.”
Collagen peptides (for collagen products)	Double-blind, randomised, placebo-controlled trial	64 adults	1,000 mg/day; 12 weeks	Improved skin hydration and wrinkling measures; no adverse symptoms reported	“In a double-blind, placebo-controlled human study, collagen peptide supplementation was associated with improved skin hydration and appearance measures over 12 weeks.”

Full citations (APA)

1. Ashwagandha (stress/cortisol)

   
   

   Lopresti, A. L., Smith, S. J., Malvi, H., & Kodgule, R. (2019). An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine (Baltimore), 98(37), e17186. https://doi.org/10.1097/MD.0000000000017186

2. Maca (postmenopausal psychological symptoms/sexual function measures)

   
   

   Brooks, N. A., Wilcox, G., Walker, K. Z., Ashton, J. F., Cox, M. B., & Stojanovska, L. (2008). Beneficial effects of Lepidium meyenii (Maca) on psychological symptoms and measures of sexual dysfunction in postmenopausal women are not related to estrogen or androgen content. Menopause, 15(6), 1157–1162. https://doi.org/10.1097/gme.0b013e3181732953

3. L-theanine (stress-related symptoms/sleep indices)

   
   

   Hidese, S., Ogawa, S., Ota, M., Ishida, I., Yasukawa, Z., Ozeki, M., & Kunugi, H. (2019). Effects of L-Theanine administration on stress-related symptoms and cognitive functions in healthy adults: A randomized controlled trial. Nutrients, 11(10), 2362. https://doi.org/10.3390/nu11102362

4. Lion’s Mane (MCI cognitive scale)

   
   

   Mori, K., Inatomi, S., Ouchi, K., Azumi, Y., & Tuchida, T. (2009). Improving effects of the mushroom Yamabushitake (Hericium erinaceus) on mild cognitive impairment: A double-blind placebo-controlled clinical trial. Phytotherapy Research, 23(3), 367–372. https://doi.org/10.1002/ptr.2634

5. Green tea extract (EGCG; weight/waist outcomes)

   
   

   Chen, I.-J., Liu, C.-Y., Chiu, J.-P., & Hsu, C.-H. (2016). Therapeutic effect of high-dose green tea extract on weight reduction: A randomized, double-blind, placebo-controlled clinical trial. Clinical Nutrition, 35(3), 592–599. https://doi.org/10.1016/j.clnu.2015.05.003

6. Collagen peptides (skin hydration/elasticity/wrinkling)

   
   

   Kim, D.-U., Chung, H.-C., Choi, J., Sakai, Y., & Lee, B.-Y. (2018). Oral intake of low-molecular-weight collagen peptide improves hydration, elasticity, and wrinkling in human skin: A randomized, double-blind, placebo-controlled study. Nutrients, 10(7), 826. https://doi.org/10.3390/nu10070826

Regulatory Framework: EFSA Health Claims (EU)

In the European Union, health and nutrition claims on food and supplements are regulated under EU law.

A health claim is defined as any statement that links a food or ingredient to a specific health benefit, such as “supports normal muscle function” or “helps maintain immune function.” Before a claim can be used on packaging or in advertising, it must be scientifically substantiated and authorized by the European Commission following rigorous assessment by the European Food Safety Authority (EFSA). (European Food Safety Authority)

Important facts:

• EFSA has evaluated thousands of health claim applications. A significant majority (over 70%) are rejected due to insufficient evidence. (European Food Safety Authority)

• Approved claims require a high level of evidence and are generally specific about the condition and populationstudied — not broad, vague statements. (European Food Safety Authority)

Bottom line: If you see an EFSA-approved claim on a supplement, that claim has passed a high scientific bar. But most “clinically studied” products do not carry an EFSA-approved claim — and there’s an important difference.

Regulatory Reality: U.S. Framework (FDA & NIH)

In the United States, supplements are regulated as foods under the Dietary Supplement Health and Education Act of 1994 (DSHEA), not as drugs. This means:

• Supplements do not require pre-market approval from the U.S. Food and Drug Administration (FDA).

• Manufacturers are responsible for ensuring safety and truthful labelling.

• Claims must not allege treatment of disease unless backed by significant scientific agreement or authorised health claims.

• Research can be used in marketing even if it does not meet rigorous clinical standards. (Wikipedia)

The NIH Office of Dietary Supplements (ODS) provides fact sheets and summaries of evidence for supplement ingredients, but this is educational, not regulatory approval. (Office of Dietary Supplements)

What High-Quality Evidence Looks Like in Supplements

To illustrate the complexities of supplement science, here are examples from well-conducted evidence reviews:

Omega-3 Fatty Acids

Cochrane systematic reviews, which synthesise multiple high-quality trials, suggest that long-chain omega-3 supplements (EPA, DHA) have little or no significant effect on reducing overall cardiovascular disease risk or mortality in the general population. (Cochrane)

Vitamin D

Cochrane reviews show that vitamin D supplementation may have specific benefits in certain populations — for example, reducing risk of preterm birth or asthma exacerbations in some clinical settings — but evidence for broad population-wide effects (like fracture prevention without calcium) remains limited or inconsistent. (PMC)

Selenium and Vitamin E

Large clinical trials like SELECT, and subsequent systematic reviews, found no convincing evidence that selenium or vitamin E supplements prevent cancer. In some analyses, supplementation was linked to increased health risks, underscoring that more is not always better. (Wikipedia)

These examples illustrate that even when supplements are “studied”, the results often show modest, mixed, or null effects on meaningful health outcomes — a nuance that marketing rarely conveys.

Why “Clinically Studied” Doesn’t Equal “Clinically Proven”

When a company says its product is “clinically studied,” they might be relying on:

• Trials using different dosages or formulations

• Research conducted on isolated ingredients rather than finished products

• Studies in very specific populations that cannot be generalised

• Outcomes that don’t translate to real-world health benefits

This is why it’s essential to look beyond the phrase and ask:

• What was studied?

• Who was studied?

• Was the dose relevant?

• Did the outcome matter to health?

A Practical Checklist for Reading Claims

Use this checklist before you trust a “clinically studied” claim:

Question	Why It Matters
Was the study conducted in humans?	Lab or animal studies alone cannot prove human benefit.
Is the specific ingredient and dose identical to the product?	Different forms/doses can produce different effects.
Was the study randomised and controlled?	Strong designs reduce bias and false conclusions.
Is the outcome clinically meaningful?	“Improved marker X” isn’t the same as “reduced disease risk.”
Was the research peer-reviewed?	Peer review adds quality assurance.

How to Use Evidence Wisely

A “clinically studied” label should prompt curiosity, not blind trust. Real evidence should help you:

• Choose supplements based on actual human outcomes

• Understand that quality, dose, and relevance matter more than buzzwords

• Recognise that even well-studied supplements are not universal fixes

For reliable information, consult resources like:

• NIH Office of Dietary Supplements fact sheets — a library of ingredient-specific science summaries. (Office of Dietary Supplements)

• Cochrane Reviews — rigorous systematic reviews of clinical trial evidence. (Cochrane)

• EFSA health claims database — approved science-based claims in the EU. (European Food Safety Authority)

Conclusion: Trust Through Transparency

The phrase “clinically studied” can be meaningful — if the underlying research is transparent, relevant, and robust. In a marketplace filled with noise and marketing, knowing how to read evidence makes you a smarter consumer and supports your long-term health goals.

Remember, science is powerful — but only when interpreted accurately and applied responsibly.