General presentation · 2011. 7. 17. · General presentation A Newly-approved safe ingredient for effective weight management promotion April 2011 2 Table of contents Designed for

1

General presentation A Newly-approved safe ingredient for effective

weight management promotion

April 2011

2

Table of contents

Designed for consumers

Scientific evidence

Regulatory status

Technological data

Marketing potential

Conclusion

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Chromax® is a patented salt of trivalent chromium (Cr3+) and tri-picolinic acid,

also known as chromium picolinate, containing 12% of pure chromium

Chromax® is the purest chromium picolinate on the market

recognized as a quality reference.

As a safe product and a source of bioavailable chromium,

Chromax® made the proof of its efficiency though numerous

clinical studies

What is Chromax®?

A newly-approved safe ingredient for effective

weight management promotion

Chromax® is the only chromium picolinate approved by the EU.

Its high purity and safety testing makes it superior to other

chromium products on the market.


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Chromax® is made from pure compounds using proprietary manufacturing and

quality control processes to produce a superior high purity product.

Some other chromium products on the market actually contain

less than 70% pure chromium picolinate.

The National Toxicology Program (USA) conducted safety

studies, using purified chromium picolinate, which confirmed

the long-term high dose safety of the pure chromium

picolinate compound. (Rhodes et al, 2004, Stout et al, 2009)

The safety studies were repeated and resulted in clear demonstration of the safety

of Chromax®. (See Gudi et al, 2005; Slesinski et al, 2005).

A pure and top-quality product for a superior safety

How Chromax® makes the difference?

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A pure and top-quality product for a superior safety


Chromax® is the only chromium picolinate currently on the market to benefit from

a positive opinion issued by the EFSA (European Food Safety Authority) http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

Chromax® chromium picolinate have the benefit of knowing that this is the form of

chromium picolinate used as a standard for approval and is also the product used in

safety and efficacy studies submitted to Regulatory authorities

When purchasing Chromax® chromium picolinate, the industry is assured of using

chromium picolinate that meets and exceeds the EU standards

Customers are better protected from lower quality products claiming to be high

purity chromium picolinate since compound purity testing is required

Chromax® is the quality reference on the market and insured a high

safety contrary other products

How Chromax® makes the difference?

http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

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The bioavailability of Chromax® has been clinically demonstrated as significantly

better compared to other sources of chromium

Consumers now have a higher confidence that Chromax® matches the high quality

standards used in the efficacy studies performed over the last 15 years

Chromax® approach contributed to raise mineral compounds’ global quality

standards for inclusion in dietary supplements and functional foods

Chromax® has been clinically demonstrated as a safe and effective product in over

15 published studies.

Chromax®: A safe and effective solution

you can rely upon Superior chromium bioavailability and efficacy

On the weight management market, consumers are often eager to find

more reliable solutions . Indeed, they often need to choose between

safety or efficacy : When they choose Chromax®, consumers are ensured

have both a safe and efficient weight management solution.


Scientific evidence

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Chromax®: Clinically proven efficacy

Chromax®: increased chromium bioavailability

2 scientific studies on chromium concentration in urine

1 scientific study on chromium concentration in tissues

Chromax®: carbohydrate metabolism regulation

More than 15 clinical studies on insulin sensitivity and glycemia regulation

Chromax®: weight management promotion

4 clinical studies on weight and fat mass loss

1 clinical study on satiety

1 clinical study on carbohydrate craving

Scientific evidence

More than 15 clinical studies on over 1 800 volunteers

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1. Stability and absorption of chromium. Anderson et al., 2004.

Volunteers: 6 mixed volunteers

Duration: 48h

Dosage: 200 µg/day of pure chromium under the form of chromium nicotinate, chromium chloride or chromium picolinate (Chromax®, 1.6 mg/day)

Scientific evidence

Increased chromium bioavailability

2. Comparison of acute absorption of chromium supplements. DiSilvestro and Dy, 2007.

Volunteers: 12 women

Duration: 24h

Dosage: 200 µg/day of pure chromium, under the form of chromium polynicotinate, chromium nicotinate-glycinate, chromium chloride or chromium picolinate (Chromax®, 1.6 mg/day)

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1. Stability and absorption of chromium. Anderson et al., 2004.

Scientific evidence


2. Comparison of acute absorption of chromium supplements. DiSilvestro and Dy, 2007.

0

500

1000

1500

2000

2500

1

Uri

nary

chro

miu

m (

ng/day)

Basal loss Chromium nicotinate Chromium chloride Chromium picolinate

* * p<0.05

0

100

200

300

400

500

600

% increase of urinary chromium after 24h

% incre

ase

of

uri

nary

chro

miu

m a

fter

24h

Chromium polynicotinate Chromium nicotinate-glycinate Chromium chloride Chromax®

* * p<0.05

Chromax® is significantly more abundant in urine than chromium nicotinate and chromium chloride, which indirectly shows that chromium picolinate is more absorbed

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Subjects: 55 male Wistar rats

Duration: 3 weeks

Dosage: 5 µg/g of diet/day of pure chromium,

under the form of chromium chloride,

chromium nicotinate or chromium picolinate

(Chromax®, 0.04 mg/g of diet/day)

Chromax® is significantly more concentrated

in liver, muscle and heart than chromium

nicotinate and chromium chloride

Scientific evidence


These studies demonstrate a significant difference in chromium

bioavailability between Chromax® and other sources of chromium

0

5

10

15

20

25

30

35

40

45

50

Liver Muscle Heart

Control CrCl CrNic CrPic

ng/m

g d

ry w

eig

ht

3. Dietary chromium effects on tissue chromium concentrations and

chromium absorption in rats. Anderson et al., 1996.

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Scientific evidence

Carbohydrate metabolism regulation

Enhancement in Insulin Sensitivity in Healthy

Volunteers following supplementation with Chromium

Picolinate. Morris et al, 1998

Volunteers: 6 healthy subjects

Duration: 10 weeks

Dosage: 1.6 mg/day of Chromax®, equivalent to 200 µg/day of pure chromium

Results:

• Significant increase of fasting levels of plasma chromium during the 5 first

weeks

• Fasting Blood glucose levels tends to decrease during the supplementation

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Scientific evidence


Enhancement in Insulin Sensitivity in Healthy

Volunteers following supplementation with Chromium

Picolinate. Morris et al, 1998

Chromax® significantly reduces Insulin-Resistance at the dosage of 1.6 mg/day

Chromax® Significantly decrease fasting Insulin at the dosage of 1.6 mg/day

0.0

0.5

1.0

1.5

2.0

2.5

3.0

PreCr 1 2 3 4 5 6 7 8 9 10 Off 1 Off 2

Insu

lin

Resis

tan

ce

(HO

MA

)

Weeks

* *

** ** ** ** **

8

15


Others studies on insulin sensitivity and glycemia regulation.

At the dosage of 200µg of pure chromium per day, 5 clinical studies showed very significant results:


Scientific evidence

Study Volunteers Duration Dosage(1) Results

Lucidi, 2005 10 with PCOS(3) 4 months 1.6 mg (200 µg) glucose tolerance

Ghosh, 2002 50 type 2 diabetics with medication 3 months 1.6 mg (200 µg) glycated hemoglobin(2) (*p<0.05)

fasting glycemia (***p<0.001)

Anderson,

1997

180 type 2 diabetics with

medication

4 months 1.6 mg (200 µg)

and 8.3 mg

(1000 µg)

glycated hemoglobin(2) (*p<0.05)

fasting glycemia (*p<0.05)

insulin production (*p<0.05)

Ravina, 1995 162 type 1 and 2 diabetics with

med.

3 months 1.6 mg (200 µg) insulin sensitivity (***p<0.001)

Evans, 1989 11 type 2 diabetics with medication 1.5 month 1.6 mg (200 µg) glycated hemoglobin(2) (*p<0.05) (1) dosage of Chromax® / day (equivalent dosage of pure chromium / day) (2) glycated hemoglobin (HbA1c) is the reference biological marker for glycemia monitoring in diabetic patients (3) PCOS = polycystic ovary syndrome, which is strongly correlated with insulin resistance and diabetes

In other dosages, more than 15 studies were conducted on Chromax® to prove this effect.

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Chromax® potentiates insulin function for a clinical

proven action on carbohydrate metabolism

Chromax® enhances the activity of insulin receptors on

cells membranes and thus increases insulin sensitivity and

glucose storage in muscle cells

Chromax®, by promoting healthy blood sugar

metabolism, reduces the storage of fat and contributes to

healthy weight management



Scientific evidence

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STUDY 1

• Volunteers: 10 healthy men

• Activity: weight lifting program, 2 periods/week

• Duration: 40 days

• Dosage: 1.6 mg/day of Chromax®, equivalent to

200 µg/day of chromium

• Results:

Significantly increase of lean body mass

(p=0.019)

Increase of body weight was due essentially to

increase in lean body mass

Scientific evidence

Weight management promotion/ Fat mass loss

STUDY 2

• Volunteers: 31 football players

• Activity: weight-training 1 hour/day

• Duration: 6 weeks

• Dosage: 1.6 mg/day of Chromax®, equivalent to

200 µg/day of chromium

• Results:

Significantly increase of lean body mass

(p=0.031)

Significant decrease in the total fat (p=0.001)

Chromium Picolinate and Body composition. Evans et al, 1989: 2 separate studies

Change in Lean Body Mass

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

1

Treatment

kg

CrPic

Placebo

*

***

*p<0.05

***p<0.005

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Scientific evidence

Weight management promotion / Fat mass loss

2. Effects of chromium picolinate supplementation on body composition. Kaats et al., 1998.

Volunteers:

• 154 mixed volunteers

• Inclusion criteria: overweight or obese (mean BMI = 30)

Duration: 72 days

Dosage: 1.6 to 3.3 mg/day of Chromax®, equivalent to 200 to 400 µg/day of pure

chromium

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2. Effects of chromium picolinate supplementation on

body composition. Kaats et al., 1998.

BCI (Body Composition Index) = net difference between lean mass gain and fat mass loss

-6

-4

-2

0

2

4

6

8

Weight loss (kg) Fat mass loss (kg) Lean mass loss (kg) Fat mass loss (% body weight) BCI (kg)

Placebo 1.6 mg/day of Chromax® 3.3 mg/day of Chromax®


Scientific evidence

*

* p<0.05

** p<0.01

*** p<0.005

Weight management promotion/Fat mass loss

* ***

* ***

*** **

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2. Effects of chromium picolinate supplementation on

body composition. Kaats et al., 1998.

Trend of body mass loss at 1.6 mg/day of Chromax®

Significant fat mass loss from 1.6 mg/day of Chromax®

No significant lean mass loss

Significant decrease of fat mass proportion from 1.6 mg/day of Chromax®

Significant improvement of body composition index from 1.6 mg/day of Chromax®


Scientific evidence

Weight management promotion/Fat mass loss

Chromax® shows significant results on weight and fat mass loss

while preserving lean mass, from the dosage of 2 mg/day

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Chromax®: Clinically proven

efficacy

Volunteers:

• 42 women

• Inclusion criteria: BMI 25-40, reporting intense carb craving

Duration: 8 weeks

Dosage: 8.3 mg/day of Chromax®,

equivalent to 1 000 µg/day of pure

chromium

Scientific evidence

Weight management promotion/ Satiety

0

50

100

150

200

250

300

350

400

After 1 week After 8 weeks

Food inta

ke r

educt

ion (

kca

l)Placebo Chromax®

Chromax® significantly reduces

food intake at the dosage of 8.3 mg/day

3. Effects of chromium picolinate on food intake and satiety. Anton et al., 2008.

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Chromax®: Clinically proven

efficacy

Scientific evidence

Weight management promotion/ Carbohydrate craving

Volunteers:

• 75 mixed volunteers

• Inclusion criteria: experiencing

atypical depression

Duration: 8 weeks

Dosage: 5 mg/day of Chromax®,

equivalent to 600 µg/day of pure

chromium

4. Exploratory trial of chromium picolinate in atypical depression: effect on carbohydrate craving. Docherty et al., 2005.

0

0.5

1

1.5

2

0 2 weeks 4 weeks 6 weeks 8 weeks

Score

Hunger Carb craving

Chromax® significantly decreases

hunger and carb craving from the dosage

of 5 mg/day

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Chromax® has greater absorption of chromium and increased bioavailability in scientifically validated studies that have been approved by regulatory authorities worldwide

Chromax® as « chromium picolinate is among the most bioavailable forms of chromium » (The EFSA Journal (2009) 1113, 1-41)

Chromax® has clinically proven efficacy on the regulation of carbohydrate metabolism at the dosage of 2 mg/day

Chromax® is a safe and effective ingredient for success in your weight management products

Scientific evidence

Conclusions

Regulatory status

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Is Chromax® authorized for use?

A food grade ingredient

USA:

• Authorized for use in food supplements

• Authorized for use in functional bars and beverages (GRAS status)

Europe*:

• Authorized for use in foodstuffs for particular

nutritional uses and foods intended for the

general population (including food supplement)

(The EFSA Journal 2010;8(12):1882) * Recommended dosage according to the current national regulations

Asia:

• Authorized for use in food supplements in most countries: Australia, Indonesia,

Malaysia, Singapore, Taiwan, Thailand,…

• Authorized for use in functional foods in most countries:

Indonesia, Singapore, Taiwan, Thailand,…

Regulatory status

A clear and well-defined regulatory status

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A health claim authorization

FDA approval for a qualified health claim regarding the

reduction of risk of insulin resistance and type II diabete

A clear label

Suggested labeling: « Chromium picolinate » (« Picolinate de chrome »)

Regulatory status

A clear and well-defined regulatory status

Is Chromax® authorized for use?

Chromax® benefits from our regulatory expertise.

Please feel free to contact us for further information.

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Technological data

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Chromax® - Purity

Analytical comparison of marketed chromium compounds

Chromium #1

(multiple compounds)

Chromax ®

(pure chromium picolinate)

Technological data

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How can Chromax® be used?

Chromax® is a fine and homogeneous powder. It is

red colored, water-soluble and pH-stable.

Thanks to its high density and to its low dosage (2 mg/day), Chromax® can easily be

implemented into various matrices:

• Food supplements: tablets, capsules, softgels, gums,…

• Functional foods: bars, dairies, chocolate, beverages,…

Several applications have already been tested by Ingredia Nutritional.

Please feel free to contact us for further information.

Technological data

Chromax® is a ready-to-use ingredient that will make the

difference in your food supplement or functional food

A flexible ingredient

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In coherence with WHO (World Health Organisation) and EFSA

conclusions, Ingredia Nutritional recommends a dosage of 2 mg/day

of Chromax®, which is equivalent to 240 µg/day of pure chromium

The WHO and EFSA concluded that pure chromium is completly

safe up to 250 µg/day and validated Chromax® complete safety

How can Chromax® be used?

Recommended dosage

For consumer, only 2 mg/day of Chromax® will provide you with

all the benefits of chromium without any concern for safety

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Marketing potential

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Marketing potential

Chromax®: Successful in applications

Chromax® shot A Newly-Approved Safe Ingredient for Effective Weight

Management. Chromax® is the first chromium picolinate that meets the high

quality standards required in the EU. Chromax® potentiates insulin function for a

clinically proven action on carbohydrate metabolism and weight management

Glycemia optimize Helps you control blood sugar level. Chromax® acts on the moderation of the glycemic answer and have an

activating action on insulin. With Glycemia optimize, you can go eating the

food you like without thinking of consequences

Fit&Slim Speed’up your metabolism. FIT&SLIM is a drink designed for

people wishing, in addition to regular physical activity, to manage their

weight and get slim. Chromax® stimulates fat elimination and enables to

develop a firm, fit and slim body.

One bioactive for multiple applications!

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Chromax®: Successful in applications

One bioactive for multiple applications!

Eat Less Helps you reach a healthy diet naturally. Eat less is an original

formulation composed of specific high-end chromium picolinate: Chromax®. It has

a double action both on physical satiety and on hormonal signals. This delicious

beverage allows you to experience satiety and reduce your food intake, in order to

reach you the silhouette of your dreams.

Stop snacking Control food craving for a successfull diet Snacking is the

first cause of failure during long-time diet. Thanks to its exclusive ingredient

Chromax®, which act on the carbohydrate metabolism, Stop snacking will help you

get the strength to resist temptation and achieve a successful diet.

Chromax® BMR (Body Mass Reduction) Your partner for an athletic

body With Chromax®, lose your fat mass while preserving your muscular one.

Coupled with an intense physical activity, Chromax® BMR will help you get rid of

excess body fat without sacrificing your muscles.

Conclusion

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Why choose Chromax®?

Chromax®

Conclusion

Clinically proven

efficacy on carbohydrate

metabolism regulation,

increased bioavailability,

and weight management

Easy implementation in dietary

supplements and food matrices

The most effective at the best price

The best value for money

of the market!

The purest and the safest chromium picolinate

on the market of the chrome products

Chromax® is the quality

reference and has high

safety compared to other

products

Chromax® established its

proof of efficacy though

numerous clinical studies

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References

Anderson, R.A. ; Bryden, N.A. ; Polansky, M.M. ; Gautschi, K. (1996). Dietary chromium effects on

tissue chromium concentrations and chromium absorption in rats. The Journal of Trace Elements in

Experimental Medicine ; 9 ; 11-15.

Anderson, R.A. ; Cheng, N. ; Bryden, N.A. ; Polansky, M.M. ; Chi, J. ; Feng, J. (1997). Elevated

intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2

diabetes. Diabetes ; 46 ; 1786-1791.

Anderson, R.A. ; Polansky, M.M. ; Bryden, N.A. (2004). Stability and absorption of chromium and

absorption of chromium histidinate complexes by humans. Biological Trace Element Research ; 101 ;

211-218.

Anton, S.D. ; Morrison, C.D. ; Cefalu, W.T. ; Martin, C.K. ; Coulon, S. ; Geiselman, P. ; Han, H. ;

White, C.L. ; Williamson, D.A. (2008). Effects of chromium picolinate on food intake and satiety.

Diabetes Technology and Therapeutics ; 10(5) ; 405-412.

Bahadori, B. ; Wallner, S. ; Hacker, C. ; Boes, U. ; Komorowski, J.R. ; Wascher, T.C. (1999).

Effects of chromium picolinate on insulin levels and glucose control in obese patients with type-II

diabetes mellitus. Diabetes ; 48 ; A349.

Cefalu, W.T. ; Bell-Farrow, A.D. ; Stegner, J. ; Wang, Z.Q. ; King, T. ; Morgan, T. ; Terry, J.G.

(1999). Effect of chromium tripicolinate on insulin sensitivity in vivo. The Journal of Trace Elements

in Experimental Medicine ; 12 ; 71-83.

Conclusion

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References

Cheng, N. ; Zhu, X. ; Shi, H. ; Wu, W. ; Jiamin, C. ; Jianying, C. ; Anderson, R.A. (1999). Follow-

up survey of people in China with type 2 diabetes mellitus consuming supplemental chromium. The

Journal of Trace Elements in Experimental Medicine ; 12 ; 55-60.

DiSilvestro R.A. ; Dy, E. (2007). Comparison of acute absorption of commercially available

chromium supplements. The Journal of Trace Elements in Medicine and Biology ; 21 ; 120-124.

Docherty, J.P. ; Sack, D.A. ; Roffman, M. ; Finch, M. ; Komorowski, J.R. (2005). A double-blind,

placebo-controlled, exploratory trial of chromium picolinate in atypical depression: effect on

carbohydrate craving. Journal of Psychiatric Pratice ; 11(5) ; 302-314.

Evans, G.W. (1989). The effect of chromium picolinate on insulin controlled parameters in humans.

Int. J. Biosocial. Med. Res. ; 11 ; 163-180.

Feng, J ; Lin, D. ; Zheng, A. ; Cheng, N. (2002). Chromium picolinate reduces insulin requirement

in people with type 2 diabetes mellitus. Diabetes ; 51 ; A469.

Ghosh, D. ; Bhattacharya, B. ; Mukherjee, B. ; Manna, B. ; Sinha, M. ; Chowdhury, J. ;

Chowdhury, S. (2002). Role of chromium supplementation in Indians with type 2 diabetes mellitus. J.

Nutr. Biochem. ; 13 ; 690-697.

Jovanovic-Peterson, L. ; Gutlerrez, M. ; Peterson, C.M. (1999). Chromium supplementation for

women with gestational diabetes mellitus. The Journal of Trace Elements in Experimental Medicine ;

12 ; 91-97.

Conclusion

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References

Kaats, G.R. ; Blum, K. ; Fisher, J.A. ; Adelman, J.A. (1998). Effects of chromium picolinate

supplementation on body composition: a randomized, double-masked, placebo-controlled study. Current

Therapeutic Research ; 57(10) ; 747-756.

Lucidi, R.S. ; Thyer, A.C. ; Easton, C.A. ; Holden, A.E.C. ; Schenken, R.S. ; Brzyski, R.G. (2005).

Effect of chromium supplementation on insulin resistance and ovarian and menstrual cyclicity in women

with polycystic ovary syndrome. Fertil. Steril. ; 84 ; 1755-1757.

Lydic, M.L. ; McNurlan, M. ; Bembo, S. ; Mitchell, L. ; Komaroff, E. ; Gelato, M. (2006). Chromium

picolinate improves insulin sensitivity in obese subjects with polycystic ovary syndrome. Fertil. Steril. ;

86 ; 243-246.

Martin, J. ; Wang, Z.Q. ; Zhang, X.H. ; Wachtel, D. ; Volaufova, J. ; Matthews, D.E. ; Cefalu, W.T.

(2006). Chromium picolinate supplementation attenuates body weight gain and increases insulin

sensitivity in subjects with type 2 diabetes. Diabetes Care ; 29(8) ; 1826-1832.

Morris, B.W. ; Kouta, S. ; Robinson, R. ; MacNeil, S. ; Heller, S. (2000). Chromium supplementation

improves insulin resistance in patients with type 2 diabetes mellitus. Diabet. Med. ; 17 ; 684-685.

Rabinovitz, H. ; Leibovitz, A. ; Madar, Z. ; Gabai, G. ; Habot, B. (2000). Blood glucose and lipid

levels following chromium supplementation in diabetic elderly patients on a rehabilitation program.

Gerontologist ; 40.

Conclusion

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References

Ravina, A. ; Slezak, L. ; Rubal, A. ; Mirsky, N. (1995). Clinical use of the trace element chromium

(III) in the treatment of diabetes mellitus. The Journal of Trace Elements in Experimental Medicine ; 8 ;

183-190.

Ravina, A. ; Slezak, L. ; Mirsky, N. ; Bryden, N.A. ; Anderson, R.A. (1999). Reversal of

corticosteroid-induced diabetes mellitus with supplemental chromium. Diabet. Med. ; 16 ; 164-167.

Vrtovec, M. ; Vrtovec, B. ; Briski, A. ; Kocijancic, A. ; Anderson, R.A. ; Radovancevic, B. (2005).

Chromium supplementation shortens QTc interval duration in patients with type 2 diabetes mellitus.

American Heart Journal ; 149(4) ; 632-636.

Wang, Z.Q. ; Qin, J. ; Martin, J. ; Zhang, X.H. ; Sereda, O. ; Anderson, R.A. ; Pinsonat, P. ; Cefalu,

W.T. (2007). Phenotype of subjects with type 2 diabetes mellitus may determine clinical response to

chromium supplementation. Metabolism ; 56 ; 1652-1655.

Conclusion

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www.ingredia-nutritional.com

Thank you for your attention!

Documents

General presentation · 2011. 7. 17. · General presentation A Newly-approved safe ingredient for effective weight management promotion April 2011 2 Table of contents Designed for