EP EPIDEMIOL IDEMIOLOGIC OGICAL AL ST STUDIES: UDIES: tools - - PowerPoint PPT Presentation

SATURDAY MARCH 15TH 2014

Eline Eline M.

• M. van

van der der Beek Beek Research Director, Singapore

PPP PPP IN INSIGH SIGHTS TS FR FROM OM PRECLINIC PRECLINICAL AND AL AND EP EPIDEMIOL IDEMIOLOGIC OGICAL AL ST STUDIES: UDIES:

tools tools to s to sha hape nutr pe nutrit itional ional inter intervention ention tr trials ials

For non-commercial use only

THE THE FIRS FIRST T 1,0 1,000 00 DAYS OF LIF OF LIFE E AR ARE E CR CRUC UCIAL IAL

• 9 to 0 m

0 to 6 m > 12 m 6 to 12 m

INNOVATION EXAMPLE 1:

SAFETY & EFFICACY of scGOS-lcFOS

Clinical studies

(Proof of Concept)

Clinical studies

(Proof of Efficacy)

Excellence in clinical studies to provide the credible evidence

 ICH – GCP

(Int’l Conference on Harmonisation / WHO Good Clinical Practice)

 ISO 9001-2000 certified

since 2007. Recertified in March 2013

OUR TRANSLATIONAL R&D APPROACH:

Clinical trials in humans In vivo animal models In vitro animal cells In vitro human cells In vitro mechanistic

Clinical trial design: To test a possible effect on growth & body composition development in young children

Age (months)

0 3 12 24 36 48 60 72 84 96

BMI (kg/m2)

13 14 15 16 17 18 19 20 21 normal weight at 8 yrs of age

• verweight at 8 yrs of age

1.4% obese 9.1% overweight

Peak BMI Adiposity rebound

Dutch Birth Cohort 1996-1997 N = 3963

Scholtens et al, Ped Res, 2007; Willers, PLoSOne, 2012

Infant BMI predictive for childhood

• verweight

FOCUS ON 2: EARLY GROWTH AND ADIPOSITY

Toolbox development

1.

Validation of pre-peritoneal fat mass as proxy for visceral fat

2.

Ultrasound methodology is a valid methodology for visceral fat measurements in epidemiological and clinical studies

Mook-Kanamori et al (2009) Ultrasound Med Biol 35: 1938-1946

Method implemented in VENUS trial

FOCUS ON 2: EARLY GROWTH AND ADIPOSITY

Rapid growth rate is associated with increased abdominal fat mass

Durmuş et al (2010) Clin Endocrin 72: 633-640

FOCUS ON 2: EARLY GROWTH AND ADIPOSITY

Growth patterns associated with visceral fat mass development

Durmuş et al (2010) Clin Endocrin 72: 633-640

Infants at higher risk Preterm, SGA, failure to thrive

1st tertile 2nd tertile 3rd tertile

• 25
• 20
• 15
• 10
• 5

5 10 15 20 catch down non-changers catch-up Difference inpreperitoneal area(%)

Association between infant growth patterns and visceral fat mass at 2 year

KEY OUTCOMES FOCUS ON 2

Validation of US measurements: non-invasive, low costs, detailed insights Pre-peritoneal fat mass as proxy for visceral fat mass Distribution of fat mass changes in first 2 years Early postnatal (but not fetal) growth is associated with visceral fat mass at 2 years of age Slow fetal growth and rapid postnatal growth increases adiposity at 2 years of age Toolbox: US measurements to assess visceral fat in clinical trial (VENUS)

KEY OUTCOMES FOCUS ON 5

Beneficial effects of breastfeeding duration and exclusivity on later adiposity and metabolic disease risk are strongly ameliorated by life style factors Fetal growth deceleration and postnatal growth acceleration is associated with increased adiposity at 6 yrs Postnatal, but not fetal, growth is linked to adiposity at 6 yrs.

Gishti et al, AJCN accepted; Gishti et al, JCEM accepted

Food industr

• od industry is

y is the br the bridge bet idge between een science science, r , regula gulation and tion and consu consumer mer

Regulation Food Industry Consumer Science

Production capacity Distribution Marketing Education

Industry R&D

15 May 2011

13

Early Life Nutrition Forum

DANONE RESEARCH

% of women

• f child-

bearing age

NNHS (2002)

1 NNS (2000); 2 NSW Pop. HS

(2005) 4th HES (2010) Mans (2003) WHO (1998) Riskesdas (2007)

Underweight

BMI <18.5

8%

BMI <18.5

26.3% 1

BMI <18.5

17.2%

(15-29yo)

3.4%

(30-44yo) BMI <18.5

13.5%

(20-29yo)

5.8%

(30-39yo)

• Mid upper arm

circumference <1SD

13.6%

(15-45 yo)

Overweight and Obesity

BMI ≥ 24

30.2%

BMI ≥ 25

16.3%

(≥ 16yo) 2 BMI ≥ 25

20.6%

(15-29yo)

44.2%

(30-44yo) BMI ≥ 25

28.8%

(20-29yo)

38.6%

(30-39yo) BMI ≥ 25

27%

(≥ 18yo) Central obesity, M>90cm, F>80cm:

17.9%

(25-34yo, M&F)

24.4%

(35-44yo, M&F)

Pre-pregnancy

Nutritional Status

Many women in the region enter pregnancy with suboptimal weight.

Female overall: 29%

14

folic acid↓ iron↓ iodine↓ iron↓ folic acid↓ vit A↓ vit D↓ iodine↓ iron↓ folic acid↓ vit A↓ iodine↓ vit D↓ iodine↓ calcium↓ iron↓ vit D↓ iron↓ folic acid↓ iodine↓ calcium↓

Nut Nutrition ritional al issu issues es in in Eur Europ

• pe

e (NP (NP da data ta)

Key issues (intake vs RDA*):

• Iron (42-95% of RDA)
• Folic acid (42-87% of RDA)
• Iodine (65->100% of RDA)
• Vit D (23-64% of RDA)

Literature search + expert interviews

low mid high evidence

* RDA: recommended daily allowance

15

iron↓ calcium↓ vit D↓ iron↓ vit D↓ folic acid↓ Literature search + expert interviews

low mid high evidence

iron↓ sodium↑ vit A↓ vit B1/B2↓ calcium↓ iron↓ calcium↓ iron↓ magn.↓

Nut Nutrition ritional al issu issues es in in Asia Asia (NP (NP da data ta)

vit D↓ iodine↓ iron↓ vit B1↓ calcium↓ vit A↓ vit B2↓ iodine↓ vit A↓ folic acid↓ iron↓ calcium↓

Additional issues in Asia

(intake vs RDA*):

• Calcium (32-40% of RDA)
• Vit A (32-63% of RDA)
• Vit B1 (60-86% of RDA)
• Vit B2 (41-93% of RDA)

* RDA: recommended daily allowance

HEALTH / CONSUMER NEEDS of Maternal Milk

* Lit Literature revi view * Nutrit itiona ional l & hea healt lth s status * P Publi lic hea healt lth i issue ssues

Pha Phase se 1

* Loc Local l experts s int intervi views * Ide Identify ify gaps s

• f kno

knowledg ledge

Pha Phase se 2

* Additional studies to fill the knowledge gaps e.g. food intake & nutritional status studies

Pha Phase se 3 Many micro- nutrients intake during pregnancy was unknown. Seafast study to evaluate nutritional gaps and the barriers of milk consumption during pregnancy Pre-pregnancy: Folate or vit D insufficiency, low Ca intake. Poor nutritional status during Pregnancy: Low weight gain, iron deficiency anemia, low vit A intake. Low SES is one of the factors. Food taboos is common.

INDONESIA

(SariHusada)

Nutriplanet Indonesia

HEALTH / CONSUMER NEEDS of Maternal Milk

INDONESIA

(SariHusada)

Pha Phase se 4

* S SET ET U UP P busi siness ss & nu & nutrit itiona ional l

• bjecti

jectives s & APP & APPLY Y st study y result sults s in t in terms ms

• f products

s Reno/In Inno, , commu mmunica ication ion sup support, , partnership ship for endorseme sement

Innovation to fill the nutritional gaps: Innovation to address the milk consumption barrier:

• Fresh fruity taste (to overpower

the nauseating effect)

• One glass a day with essential

nutrients (practical)

• Affordable price Rp 3000/day

(<10% of monthly expenditure)

Other brands: 19-27%

Pha Phase se 5

MEASU EASURE RE busi siness ss impa impact CO/CANN: 45-48 % Additional CANN: 81.5 bio IDR (6,7 M€) Volumes: 1200 Tons

(budgeted 1312)

Ma Mater ternal nal Nutr Nutritional itional Pr Products

• ducts

in in 3 ASP 3 ASPAC C countries countries

Context: Barriers of consuming milk (nauseating) in CDE SE-class.

• Affordable maternal product to fill

nutrient gaps during pregnancy.

• Fresh fruity taste, 1 glass a day

Indonesia Australia

Context: Supplement to fill a gap in 5 key

nutrients in pregnancy and during breastfeeding

based on Nutritional Survey Data & recommendations by the Australian Government. Context: Milk is perceived as nutritious & important during pregnancy but is not part of dietary habit.

• Maternal milk supplement in the

country tailored for the specific periods of pregnancy & lactation

• Concentrated format for

convenience: one serving a day

Thailand

OUR TRANSLATIONAL R&D APPROACH: To know specific concerns regarding age-specific nutritional intake To translate the science into concepts that may help to address nutritional gaps and improve health To investigate the effects of these concepts in clinical setting To understand the mechanisms behind the observed effects

Clinical trials in humans In vivo animal models In vitro animal cells In vitro human cells In vitro mechanistic

THANK YOU