2
cognitive enhancing effects on primary, secondary and working memory in both healthy young and elderly volunteers 1 , 5 . Sage extracts have been shown to inhibit acetylcholinesterase, an enzyme that breaks down esters of the neurotransmitter acetylcholine, which plays an important role in the formation of memories 6 . They also possess strong antioxidant and anti-inflammatory properties. In addition, chronic administration has been shown to reduce cognitive decline in patients with Alzheimer’s disease (AD) 7 . Clinical Studies Improved Memory and Attention in Older Volunteers The cognitive-enhancing properties of Sibelius™:Sage have been confirmed in Sibelius Natural Products’ clinical study on 20 healthy elderly volunteers (65-90 years old). The administration of 167 mg and 333 mg of Sibelius™:Sage to healthy seniors, has shown to significantly improve their cognitive performance within 1 hour of treatment, including improvement of secondary memory — recognition and recall—, accuracy and speed of attention 1 (Fig. 1). Figure 1. Effects of a standardized extract of S. officinalis, Sibelius™:Sage, (167, 333, 666, 1332 mg) and placebo on cognitive factors derived from CDR computerized assessment battery. Mean change from baseline scores are shown for a) secondary memory and b) accuracy of attention. S. officinalis better cognitive performance than S. lavandulifolia In 2010, a clinical study of Salvia officinalis and Salvia lavandulifolia essential oils investigated the effect on cognition and mood in 135 healthy adults. The S. officinalis group performed significantly better than the S. lavandulifolia and control groups on the quality of memory and secondary memory 8 . What is Sibelius™:Sage? It is a branded, scientifically evidenced and clinically validated dried sage extract (Salvia officinalis L.), specially designed to enhance memory and alertness and maintain cognitive health*. It derives from a proprietary, non-GMO cultivar of sage grown in the UK and is standardised to 2.5% rosmarinic acid. The sustainable source and well-controlled manufacturing process of Sibelius™:Sage ensures a safe and high-quality product. Why Sage? Sage (Salvia officinalis L.) is a non-toxic European herb that has a long tradition for cognitive improvement dating back to the Middle Ages 4 . Clinical studies have demonstrated sage’s The Natural Way to Remember! 20 a 0 -20 -40 -60 -80 1h 2.5h 4h 6h 3 b 2 1 0 -2 -1 1h 2.5h 4h 6h -3 ***** * * ***** **** * * **** ** ** PLACEBO 167 mg 333 mg 666 mg 1332 mg *p<0.05 **p<0.01 ***p<0.001 ****p<0.001 *****p<0.005 KEY BENEFITS 1. Clinically validated cognitive benefits 1 2. Patent Pending 2 3. GRAS 3 4. TFDA registered 5. Non-GMO 6. Standardised to 2.5% rosemarinic acid 7. Suitable for multiple delivery formats

What is Sibelius™:Sage? Clinical Studies · Sibelius™:Sage have been confirmed in Sibelius Natural Products’ clinical study on 20 healthy elderly volunteers (65-90 years old)

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Page 1: What is Sibelius™:Sage? Clinical Studies · Sibelius™:Sage have been confirmed in Sibelius Natural Products’ clinical study on 20 healthy elderly volunteers (65-90 years old)

cognitive enhancing effects on primary, secondary and working memory in both healthy young and elderly volunteers1,5. Sage extracts have been shown to inhibit acetylcholinesterase, an enzyme that breaks down esters of the neurotransmitter acetylcholine, which plays an important role in the formation of memories6. They also possess strong antioxidant and anti-inflammatory properties. In addition, chronic administration has been shown to reduce cognitive decline in patients with Alzheimer’s disease (AD)7.

Clinical StudiesImproved Memory and Attention in Older VolunteersThe cognitive-enhancing properties of Sibelius™:Sage have been confirmed in Sibelius Natural Products’ clinical study on 20 healthy elderly volunteers (65-90 years old). The administration of 167 mg and 333 mg of Sibelius™:Sage to healthy seniors, has shown to significantly improve their cognitive performance within 1 hour of treatment, including improvement of secondary memory — recognition and recall—, accuracy and speed of attention1 (Fig. 1).

Figure 1. Effects of a standardized extract of S. officinalis, Sibelius™:Sage, (167, 333, 666, 1332 mg) and placebo on cognitive factors derived from CDR computerized assessment battery. Mean change from baseline scores are shown for a) secondary memory and b) accuracy of attention.

S. officinalis better cognitive performance than S. lavandulifolia

In 2010, a clinical study of Salvia officinalis and Salvia lavandulifolia essential oils investigated the effect on cognition and mood in 135 healthy adults. The S. officinalis group performed significantly better than the S. lavandulifolia and control groups on the quality of memory and secondary memory8.

What is Sibelius™:Sage?It is a branded, scientifically evidenced and clinically validated dried sage extract (Salvia officinalis L.), specially designed to enhance memory and alertness and maintain cognitive health*. It derives from a proprietary, non-GMO cultivar of sage grown in the UK and is standardised to 2.5% rosmarinic acid. The sustainable source and well-controlled manufacturing process of Sibelius™:Sage ensures a safe and high-quality product.

Why Sage?Sage (Salvia officinalis L.) is a non-toxic European herb that has a long tradition for cognitive improvement dating back to the Middle Ages4. Clinical studies have demonstrated sage’s

The Natural Way to Remember!

20a

0

-20

-40

-60

-801h 2.5h 4h 6h

3b

2

1

0

-2

-1

1h 2.5h 4h 6h-3

*****

* * *********

**

**** ****

PLACEBO 167 mg 333 mg 666 mg 1332 mg

*p<0.05 **p<0.01 ***p<0.001 ****p<0.001 *****p<0.005

KEY

BEN

EFIT

S 1. Clinically validated cognitive benefits1

2. Patent Pending2

3. GRAS3

4. TFDA registered5. Non-GMO6. Standardised to 2.5% rosemarinic acid7. Suitable for multiple delivery formats

Page 2: What is Sibelius™:Sage? Clinical Studies · Sibelius™:Sage have been confirmed in Sibelius Natural Products’ clinical study on 20 healthy elderly volunteers (65-90 years old)

Improved Cognitive Performance in Young Adults

In a double blind, placebo controlled cross over study, 30 healthy participants (20 -29 years old) were given a Salvia officinalis extract or placebo and tested for stress, mathematical processing, word processing, response time, memory and mood. Improved mood and cognitive performance were noted after a single dose administration of 300 mg sage extract5.

Other StudiesSibelius™:Sage, a Unique Ingredient

The challenge has been to identify the unique characteristics of Sibelius™:Sage over other sage extracts, obtained from different sources and extraction procedures. Using Chronoscreen™, Sibelius Natural Products’ patented technology, we have been able to demonstrate that there is a significant difference in the biological activity of Sibelius™:Sage, over other sage extracts (Fig. 2).

Figure 2. Chronological Life Extension (CLS Extension) is measured using Sibelius’ patented ChronoscreenTM

technology, and allows for the identification of biologically active natural products in the

model organism C. elegans. Sibelius®: Sage shows increases in lifespan

of around 10-15%.

Anti-inflammatory Effects of Sibelius™:Sage

Circulating inflammatory markers, including the vascular injury markers Intercellular Adhesion Molecule-1 (ICAM-1) and Vascular Cell Adhesion Molecule-1 (VCAM-1), have been noted in patients with cognitive disease such as AD9-12. Sibelius™:Sage caused a significant reduction in the basal level of release of VCAM-1, as well as IL-1β induced conditions in human cells (Fig. 3 A & B). Sibelius™:Sage also caused a significant reduction in ICAM-1 in IL-1β induced in vitro (Fig. 3 C & D), as well as other inflammatory markers (data not shown).

Figure 3. Effects of Sibelius™:Sage on vascular injury markers.

VCAM-1 (A & B) and ICAM-1 markers (C & D) were tested in human adipocyte cells after 4h (A & C) or 24h (B & D) exposure to either a low dose (LD; 5µg/ml) or high dose (HD; 50µg/ml) of Sibelius™:Sage in the presence or absence of stimulation with IL-1β (0.5ng/ml).

Awards & Certifications

Sibelius Natural Products

26 Beaumont Street, Oxford, OX1 2NP, UK

www.sibeliusnaturalproducts.com

S. officinalis(Sibelius:Sage)

CLS

ext

ensi

on (%

)

S. officinalis(UK Source A)

S. officinalis(UK Source B)

S. officinalis(UK Spain)

15

10

5

0

-5

-10

-15

Con

trol

IL-1β

Sibe

lius™

:Sa

ge LD

Sibe

lius™

:Sa

ge H

D

IL-1β

+ S

ibel

ius™

:Sa

ge LD

IL-1β

+ S

ibel

ius™

:Sa

ge H

D

Con

trol

IL-1β

Sibe

lius™

:Sa

ge LD

Sibe

lius™

:Sa

ge H

D

IL-1β

+ S

ibel

ius™

:Sa

ge LD

IL-1β

+ S

ibel

ius™

:Sa

ge H

D

VC

AM

-1

4h A

10

0

30

20

404h B

50

100

0

150

ICA

M-1

C

20

0

60

40

100

80

D

10

2030

300600

900

12001500

0

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Citations

1 Scholey A.B., et al. (2008), Psychopharmacology, 198: 127-139.

2 Sibelius™:Sage Patent (pending): WO 2017/129987 A1, published August 3, 2017.

3 GRAS: 21CFR182.10 and 21CFR182.20.

4 Kennedy, D.O, et al. (2006), Current Pharmaceutical Design, 12:2631-4623.

5 Kennedy, D.O. et al. (2006), Neuropsychopharmacology, 31:845-852.

6 Hasselmo, M.E. (2006), Current Opinion in Neurobiology, 16: 710-715.

7 Akhondzadeh, S. et al. (2003), Journal of Clinical Pharmacy and Therapeutics, 28:53-59.

8 Moss, L. et al. (2010), Human Psychopharmacology, 25: 388-396.

9 Rentzos, M. et al. (2004), Journal of Geriatric Psychiatry and Neurology, 17(4):225-231.

10 Nielsen, H. M. et al. (2007), Neurobiology of disease, 26:37-35.

11 Zuliani, G. et al. (2008), Journal of Neurological Sciences, 272:164-170.

12 Sobbani, A. et al. (2018), Journal of Neurology and Neuroscience, 9:1-6.

Hermes Consilium Ltd. is the official and exclusive distributor of Sibelius™:Sage in your region. We look forward to assisting you

with more information on the ingredient or finished products, into which the ingredient is formulated.

ContactE: [email protected]

W: www.hermes-consilium.comT: + 386 1 434 5678

A: Hermes Consilium Ltd., Cesta v Mestni log 88a, 1000 Ljubljana, SI – European Union

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