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Jukka-Pekka Suomela 2014 Research examples from the perspective of planning
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Case: berry project Funded by TEKES (the Finnish Funding Agency for Innovation) Partial funding from six companies Collaboration between different faculties/departments and between the six companies A large project lasting over 3 years Three separate trials
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Figure Overall scheme of the clinical trials. Trial I: For Diet 1, all the berries/products are included in one complete diet in consecutive meals. Group B is given a control diet. Trial II: A sensory evaluation of test products with children aged four to nine years. Trial III: Sea buckthorn and bilberry are utilized, and sea buckthorn is fractionated. Phenolic (flavonoid) and lipid fractions, as well as whole berry products are included in the diet in random order.
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Figure Schedule
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Figure Budget
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Figure. Co-operators of the research team and the persons in charge.
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Trial 1 The aim of the study wast to investigate the effect of a berry diet consisting of blackcurrant, bilberry, lingonberry and sea buckthorn berries on the risk factors of type 2 diabetes in overweight women During intervention, each day 162.6 g berries and oil from 35 g of berries, divided into three portions Test products – lots of discussion between the researchers and companies Whole berries, juices, berry oils, powders, lingonberry bread
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Trial 1
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Recruiting Advertisements in e-mail lists, newspaper and notice boards Normal health status and suitability for the study were checked by 1) an interview (n =162) and 2) by biochemical laboratory tests (n= 102) - inclusion and exclusion criteria Written informed consents important Randomization The subjects were randomly assigned to the two groups, intervention and control (n = 31 and 30, respectively) after stratification with LDL-cholesterol and body mass index
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Trial 1 20-week study period Blood samples collected before and after the study period (as well as in-between)
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Trial 1 Different biomarkers in blood were analyzed CRP, total, LDL and HDL cholesterol, triglycerides, insulin, glucose, ALAT, GT, adiponectin, blood pressure… ALAT level decreased 23% in the intervention group Possible enhancmenet of the liver function and lowering the risk of diabetes
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Trial 2 The hedonic response (liking score) of 104 healthy children to the 12 berry products was studied recruited from five day-care centers and three schools Another aim of the study was to study the effects of the chemical composition of berries as well as children’s hTAS2R38 taste receptor genotypes on liking. berry flavonols, sugars, organic acids and vitamin C were analyzed
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Trial 2 Prior to the sensory study, written consent was obtained from parents and verbal assent was asked from the children Prior to gene testing, 1) written consent was obtained from parents 2) verbal assent was asked from the children (day-care) or both verbal assent asked and written consent obtained (schools) Lots of planning on how to test the liking scores!
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Trial 2 Four products were tasted during each session The children evaluated the pleasantness of berry samples in each product and rated their liking score using Peryam and Kroll (P&K) scale Children at day-care were interviewed one-by-one, children in schools fi lled the evaluation form by themselves
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Trial 2 The most liked product was bilberry with yoghurt, followed by bilberry juice, dried bilberries, and lingonberry rye bread The most disliked products were sea buckthorn juice, sea buckthorn berries with yoghurt, and oatmeal with blackcurrant powder and berry oil High total organic acid concentration was strongly related with a poor average liking score of the berries/berry products The liking scores of the children of different hTAS2R38 genotypes differed from each other
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Figure. Trial 3: Conclusions that can be made of comparisons between the health state of study subjects with different diets. Intervention period 1 Intervention period 2 Intervention period 3 Intervention period 4 Wash-out Figure. Trial 3: Intervention periods of 35 days and wash-out periods of 30 days. Stars represent the timepoints where samples are taken. Trial 3
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