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Formulating Products Designed to Regulate Cortisol Levels

Formulating products designed to regulate cortisol levels requires careful consideration of the ingredients, dosages, delivery mechanisms, target demographics, and regulatory compliance.

We are providing a step-by-step guide to creating such products:

1. DEFINE PRODUCT GOALS

Objective: Determine if the product is designed for general stress relief, athletic recovery, mental clarity, or chronic stress management.

Target Audience: Identify the demographic (e.g., busy professionals, athletes, women with hormonal imbalances, seniors).

2. SELECT INGREDIENTS

Focus on scientifically-backed ingredients that regulate cortisol levels. Examples include:

Adaptogens

Ashwagandha (Withania somnifera): Known for reducing cortisol and stress.

Sabinsa has raised the quality bar for the popular adaptogen ashwagandha with Shagandha™ Ashwagandha Root Extract 2.5% USP from Withania somnifera, assured to comply with the U.S. Pharmacopoeia-National Formulary (USP-NF) monograph.

Rhodiola (Rhodiola Rosea): Enhances stress resilience.

Rhodiolife® Nektium offers a whole host of benefits for your product development objectives, across sports and cognitive health. Helping the body adapt to stress, this extensively studied ingredient is standardised to two different grades of rosavins and salidroside.This pristine adaptogen 100% identity guaranteed and supported by centuries of traditional use for mental and physical stress. Rhodiolife® is established sustainably sourced Rhodiola rosea.

Schisandra: Improves energy and modulates HPA axis activity.

Functional proteins

Hydrolysed casein: Alleviates stress-related symptoms, and helps to regulate sleep quality.

Antioxidants and anti-inflammatory agents

Saffron extract: Reduces cortisol and supports mood stabilization.

Affron® Pharmactive is a premium saffron ingredient standardized to 3.5% Lepticrosalides®, by HPLC, a complex of bioactive compounds responsible for the beneficial properties and organoleptic properties of Affron®. It is backed by 9 human clinical studies that have shown to improve mood in healthy consumers with occasional stress and anxiety, and to improve sleeplessness. A new, randomized, double-blind, placebo-controlled study showed that perimenopausal women taking Affron® for 12 weeks experienced a reduction of 32-33% in low mood and occasional stress, without undesirable estrogenic effects.

Affron® genuine quality relies on trusted sourcing, the selection of the species Crocus sativus. L and the exclusive and proprietary extraction process that uniquely concentrates and preserves the actives with low energy use.

Curcumin: Anti-inflammatory, potentially reducing stress-induced HPA axis dysregulation1. Sabinsa offers unique Curcumin C3 Reduct®. It is a standardized extract containing cascading antioxidants – Tetrahydrocurcuminoids from Curcuma longa. Tetrahydrocurcuminoids (THCs) are the colourless, hydrogenated derivatives of yellow curcuminoids (mainly curcumin, demethoxycurcumin, and bisdemethoxycurcumin) from the rhizomes of turmeric. Backed up by science and easy to formulate due to avoiding colouring in the production site.

Omega-3 fatty acids EPA and DHA: Support hippocampal function and neurogenesis.

Vitamins and minerals

Magnesium: Reduces cortisol and improves glucocorticoid metabolism.

Vitamin B5 (pantothenic acid), vitamin B3 (niacin): Supports adrenal gland function.

Zinc: Plays a role in stress hormone regulation and immunity.

Caffeine (Optional)

Use in moderate doses for targeted products like nootropics, considering its dual effects on cortisol.

3. ESTABLISH EFFECTIVE DOSAGES

Dosages must align with clinical research findings. For example:

Ashwagandha root extract: 300–600 mg/day (standardized to 5% withanolides).

Hydrolysed casein: 150-300 mg/day.

Omega-3 (EPA/DHA): up to 1 g/day combined.

Saffron stigma extract: 30 mg/day.

4. CHOOSE A DELIVERY FORM

Select a format that suits the target audience:

Capsules/tablets: Convenient and ideal for precise dosages.

Powders: Suitable for blends (e.g., products containing multiple ingredients, especially magnesium, since it takes space when formulated into a capsule).

Beverages: Appeals to consumers seeking easy-to-consume options. The ready-to-drink functional beverages market is on the rise.

Functional gummies: Growing in popularity for stress-related products. Convenient dosage without need for a water source.

5. INCORPORATE SYNERGISTIC BLENDS

Combine ingredients to enhance efficacy:

Pair adaptogens like ashwagandha and Rhodiola for comprehensive stress relief.

Combine magnesium with vitamin B6 for improved absorption.

Add saffron to mood-focused formulations with omega-3s.

6. CONDUCT STABILITY AND COMPATIBILITY TESTING

Ensure ingredients are chemically stable and compatible within the product matrix and do not interact one with another.

For example:

Check for oxidation in omega-3 formulations.

Verify adaptogens retain potency over shelf life.

7. REGULATORY COMPLIANCE

Labelling: Follow local regulations (e.g., FDA in the U.S., EFSA in Europe) for health claims.

GRAS Status: Ensure all ingredients have generally recognized as safe (GRAS) certification.

8. CONDUCT EFFICACY STUDIES

Run clinical trials or pilot studies to validate the product’s cortisol-regulating benefits. Or use ingredients that already have a proven effect in the dosages used in studies.

Collect feedback on user experience, including perceived stress reduction and energy levels.

9. MARKET POSITIONING

Highlight benefits like “Supports Stress Management,” “Promotes Balanced Cortisol Levels,” or “Boosts Resilience Against Stress.” Depends on the legislation in each country, but these claims can usually be used in B2B communication for example from finish product brand owner to pharmacist or medicine doctor.

In the EU, EFSA approved Health claims can be used for the ingredients, which can indicate their impact on stress and cortisol lowering, for example: 

Magnesium contributes to a reduction of tiredness and fatigue, contributes to normal energy-yielding metabolism, and contributes to the normal functioning of the nervous system.

Vitamin B6 contributes to normal psychological function.

Zinc, vitamin C, and riboflavin contribute to the protection of cells from oxidative stress

10. CONTINUOUS IMPROVEMENT

Monitor customer feedback and scientific advancements to refine formulations.

Stay updated on emerging cortisol-regulating ingredients for future iterations.

11. ADDITIONAL OPTIONS

Partner with companies providing cortisol analysis and applications for consumers.

By following this process, you can develop effective, safe, and marketable products for cortisol regulation and stress management.


Literature:

  1. Tizabi, Y., Hurley, L. L., Qualls, Z., & Akinfiresoye, L. (2014). Relevance of the anti-inflammatory properties of curcumin in neurodegenerative diseases and depression. Molecules (Basel, Switzerland), 19(12), 20864–20879. https://doi.org/10.3390/molecules191220864

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