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Sphere research summary

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Vitaflo's journey to discover how a GMP-based protein substitute could be brought to life, began by investigating how GMP could be safely used as a protein source for individuals with PKU. This led to the development of PKU sphere and to date 14 publications detail what we've uncovered along the way. PKU sphere is the only GMP-based protein substitute to be evaluated long-term in children and teenagers. Scroll down to learn more about the PKU sphere research that has been published since we started this journey in 2016.


2016
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Interim results found that the blend of AA's added to the GMP based PS can significantly
influence metabolic control.
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2017
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GMP-based PS were found to have better taste, mouth feel, texture, and smell than
AA based PS
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2018
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PKU sphere maintains adequate nutritional status with enhanced selenium levels
compared to AA based PS
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Initial results found that PKU sphere and AA-based PS support target blood Phe levels
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Approximately 50% of children were able to use PKU Sphere as their sole source of PS
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2019
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PKU sphere was associated with stabilisation of blood phe levels compared with AA PS
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Interim results found that bone health was supported in children taking PKU sphere
long term
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Children reported that PKU sphere has a positive impact on breath malodour
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Almost 50% of children, including some with a low Phe tolerance, were able to fully
transition to PKU sphere without adjustment of dietary Phe or compromising
metabolic control
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2020
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Preliminary results suggest that PKU sphere is digested and absorbed similarly to
AA based formulations
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No negative impact was observed on energy intake, weight gain or BMI in children taking
PKU sphere long term
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Insight into PKU sphere: a GMP-based protein substitute


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2021
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PKU sphere is the only GMP-based protein substitute evaluated long-term in children and teenagers

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A trend towards improved growth and body composition is observed in children that
consume PKU sphere as a sole source of PS
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PKU sphere supports children’s bone health when consumed long term

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