For non-commercial use only 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 SATURDAY MARCH 15 TH 2014 Eline Eline M. M. van van der der Beek Beek Research Director, Singapore
THE THE FIRS FIRST T 1,0 1,000 00 DAYS OF LIF OF LIFE E ARE AR E CR CRUC UCIAL IAL 6 to 12 m 0 to 6 m > 12 m -9 to 0 m
INNOVATION EXAMPLE 1: SAFETY & EFFICACY of scGOS-lcFOS Clinical studies Clinical (Proof of Efficacy) studies Excellence in clinical (Proof of Concept) 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: In vivo animal Clinical trials in models humans In vitro animal In vitro human cells cells In vitro mechanistic Clinical trial design: To test a possible effect on growth & body composition development in young children
Infant BMI predictive for childhood overweight 21 1.4% obese normal weight at 8 yrs of age overweight at 8 yrs of age 20 9.1% overweight 19 Dutch Birth 18 BMI (kg/m 2 ) Cohort 1996-1997 17 N = 3963 Peak BMI 16 15 Adiposity 14 rebound 13 0 3 12 24 36 48 60 72 84 96 Age (months) Scholtens et al, Ped Res, 2007; Willers, PLoSOne, 2012
FOCUS ON 2: EARLY GROWTH AND ADIPOSITY Toolbox development Validation of pre-peritoneal fat mass as proxy for visceral fat 1. Ultrasound methodology is a valid methodology for visceral fat 2. measurements in epidemiological and clinical studies Method implemented in VENUS trial Mook-Kanamori et al (2009) Ultrasound Med Biol 35: 1938-1946
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 Association between infant growth patterns and visceral fat mass at 2 year 20 15 Difference inpreperitoneal area(%) 10 3rd tertile 5 2nd tertile 0 1st tertile catch down -5 non-changers catch-up -10 -15 -20 -25 Infants at higher risk Preterm, SGA, failure to thrive Durmuş et al (2010) Clin Endocrin 72: 633-640
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 ood industry is y is the br the bridge bet idge between een science science, r , regula gulation and tion and consu consumer mer Food Industry Science Regulation Consumer Production capacity Distribution Industry Marketing R&D Education
Pre-pregnancy Nutritional Status Many women in the region enter pregnancy with suboptimal weight. % of women of child- bearing age NNHS 1 NNS (2000); 4th HES Mans (2003) WHO Riskesdas (2007) (2002) 2 NSW Pop. HS (2010) (1998) (2005) Underweight BMI <18.5 BMI <18.5 Mid upper arm 17.2% 13.5% circumference BMI <18.5 BMI <18.5 <1SD - (15-29yo) (20-29yo) 26.3% 1 8% 13.6% 3.4% 5.8% (15-45 yo) (30-44yo) (30-39yo) Overweight Central obesity, BMI ≥ 25 BMI ≥ 25 and Obesity BMI ≥ 25 M>90cm, F>80cm: 20.6% 28.8% BMI ≥ 25 27% 17.9% BMI ≥ 24 (15-29yo) (20-29yo) 16.3% 30.2% (≥ 18yo) (25-34yo, M&F) 44.2% 38.6% (≥ 16yo) 2 24.4% (30-44yo) (30-39yo) (35-44yo, M&F) Female overall: 29% 15 May Early Life Nutrition 13 DANONE RESEARCH 2011 Forum
Nutrition Nut ritional al issu issues es in in Eur Europ ope e (NP (NP da data ta) vit A↓ iodine↓ iron↓ folic acid↓ vit D↓ vit A↓ iron↓ vit D↓ folic acid↓ iodine↓ vit D↓ iodine↓ iron↓ calcium↓ folic acid↓ iron↓ folic acid↓ iodine↓ Key issues (intake vs RDA*): • Iron ( 42-95% of RDA) iodine↓ calcium↓ iron↓ • Folic acid ( 42-87% of RDA) • Iodine ( 65->100% of RDA) • Vit D ( 23-64% of RDA) * RDA: recommended daily allowance low mid high Literature search + expert interviews evidence 14
Nutrition Nut ritional al issu issues es in in Asia Asia (NP (NP da data ta) vit A↓ vit B1/B2↓ sodium↑ calcium↓ iron↓ iodine↓ calcium↓ iron↓ vit A↓ vit D↓ folic acid↓ iron↓ calcium↓ vit D↓ magn.↓ iron↓ folic acid↓ vit D↓ iron↓ Additional issues in Asia iron↓ vit A↓ (intake vs RDA*): iodine↓ vit B1↓ vit B2↓ calcium↓ • Calcium ( 32-40% of RDA) • Vit A ( 32-63% of RDA) iron↓ • Vit B1 ( 60-86% of RDA) calcium↓ • Vit B2 ( 41-93% of RDA) * RDA: recommended daily allowance low mid high 15 Literature search + expert interviews evidence
INDONESIA (SariHusada) HEALTH / CONSUMER NEEDS of Maternal Milk Phase Pha se 2 Phase Pha se 1 Phase Pha se 3 * Loc Local l experts s * Lit Literature revi view * Additional studies to fill int intervi views the knowledge gaps e.g. * Nutrit itiona ional l & hea healt lth s status food intake & nutritional * Ide Identify ify gaps s * P Publi lic hea healt lth i issue ssues status studies of kno knowledg ledge Many micro- Seafast study to evaluate Pre-pregnancy: nutrients nutritional gaps and the Folate or vit D insufficiency, intake during barriers of milk consumption low Ca intake. pregnancy was during pregnancy unknown. Poor nutritional status during Pregnancy : Low weight gain, iron deficiency Nutriplanet anemia, low vit A intake. Indonesia Low SES is one of the factors. Food taboos is common.
INDONESIA (SariHusada) HEALTH / CONSUMER NEEDS of Maternal Milk Pha Phase se 5 Phase Pha se 4 CO/CANN: 45-48 % * S SET ET U UP P busi siness ss & nu & nutrit itiona ional l MEASU EASURE RE Additional CANN : objecti jectives s & APP & APPLY Y st study y result sults s in t in terms ms busi siness ss 81.5 bio IDR (6,7 M€) of products s Reno/In Inno, , commu mmunica ication ion impa impact support, sup , partnership ship for endorseme sement Volumes: 1200 Tons (budgeted 1312) 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%
Ma Mater ternal nal Nutr Nutritional itional Pr Products oducts in in 3 ASP 3 ASPAC C countries countries 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 Thailand periods of pregnancy & lactation Concentrated format for Indonesia convenience : one serving a day Context: Supplement to fill a gap in 5 key Context: Barriers of consuming milk nutrients in pregnancy and during breastfeeding (nauseating) in CDE SE-class. based on Nutritional Survey Data & Australia • Affordable maternal product to fill recommendations by the Australian Government. nutrient gaps during pregnancy. • Fresh fruity taste, 1 glass a day
In vivo Clinical OUR TRANSLATIONAL animal trials in models humans R&D APPROACH: In vitro In vitro animal human cells cells In vitro mechanistic 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
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