Safr’Inside: the first clinically proven gummies to support the gut-sleep-brain axis

Published: 5-May-2025

Primarily known for its positive effects on stress and emotional well-being — thanks to its high concentration of safranal (0.2% by U-HPLC) — Safr’Inside has reached a significant milestone with the completion of its most recent clinical study

A first of its kind, this study evaluated the efficacy of Safr’Inside in gummy form and demonstrated its ability to modulate the gut-sleep-brain axis.

The sleep aid market is growing and, as consumers move away from melatonin-based products to avoid dependency and morning grogginess, non-melatonin gummies are gaining traction.1

This shift derives from concerns about melatonin’s inconsistent effectiveness and labelling issues, as well as the growing appeal of gummies to overcome “pill fatigue.”

Gummies offer a pleasant taste and ease of use, making them a more enjoyable and sustainable sleep solution.

Despite their “high sugar” content and limited benefits reputation, recent innovations are reshaping the perception of gummies as effective sleep aids.

Clinically proven effect on sleep

Several studies have shown the sleep-enhancing benefits of saffron, with safranal playing a “key molecule” role.2–4

Safr’Inside: the first clinically proven gummies to support the gut-sleep-brain axis

Safr’Inside, owing to its high safranal content and its demonstrated action on serotonin — the precursor of melatonin — has emerged as a strong candidate to improve sleep quality.5

To substantiate its efficacy, Activ’Inside ran a randomised, double-blind, placebo-controlled clinical study involving 52 participants who were experiencing sleep disturbances.6

For 28 days, participants were given either 30 mg of Safr’Inside in gummy form or a placebo. This study aimed to assess both subjective and objective measures of sleep improvement and to explore the relationship between the microbiota and sleep.

Subjective effectiveness: At baseline and after 28 days of supplementation, participants completed the Pittsburgh Sleep Quality Index (PSQI), a clinically validated questionnaire in which higher scores indicate poorer sleep quality.

The results showed a significant decrease in PSQI scores among participants who took Safr’Inside compared with the placebo, highlighting a notable improvement in sleep quality.

Reduction in sleep latency: An electroencephalogram (EEG) was used to analyse the participants’ sleep patterns before and after supplementation.

Sleep onset latency was significantly reduced in the Safr’Inside group compared with the placebo cohort, indicating that Safr’Inside promotes faster sleep onset.

A key link between gut health and sleep

The gut-sleep-brain axis is an emerging area of research that reveals the close relationship between the microbiome and sleep.

Safr’Inside: the first clinically proven gummies to support the gut-sleep-brain axis

The gut microbiome of participants was analysed to show that Safr’Inside induced changes in bacterial abundance.

These microbial changes were correlated with improvements in sleep, emphasising the adjacent influences between the gut microbiota and sleep regulation.

This study is also the first to demonstrate the efficacy of Safr’Inside in gummy form, highlighting that this dosage form improves adherence and effectiveness.

Appealing and clinically proven

The sleep-enhancing benefits of saffron are well established but depend on its key compound: safranal. Safr’Inside distinguishes itself with the highest safranal content and has been clinically validated to improve sleep using subjective and objective measurements.

As demonstrated by reduced PSQI scores and shorter sleep onset latency, the latest study confirms that Safr’Inside significantly enhances sleep quality.

The study also uncovered positive shifts in the gut microbiome, reinforcing the link between gut health and sleep regulation.

Safr’Inside is delivered in a sugar-free gummy format made with pectin, which not only stabilises the saffron extract but may also enhance its bioavailability.

The chewing process allows the active ingredients to be released in the mouth, potentially improving absorption. Although further scientific validation is needed to fully confirm this effect, the innovative delivery format has already proven its effectiveness by delivering clinically validated results.

References

  1. Statista.
  2. Science Direct.
  3. Wiley Sleep Study One.
  4. Wiley Sleep Study Two.
  5. Saffron Extract.
  6. Sleep quality.

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