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The trial was an extension of a previously reported 6 months trial conducted by specialists at Schneider Children’s Medical Center, Israel, led by Prof. Moshe Phillip and Prof. Raanan Shamir. The first phase was a double-blind placebo-controlled trial, comprising 200 healthy children aged 3-9 years with height and weight ≤10th percentile. The second 6-12 months phase, reported now, was an open-label extension, using the nutritional formula only, and included 150 of the first-phase participants, 129 of which completed the 6 months extension. The current study focused on children of an affluent society with low but within the normal weight and height, while most other existing studies focused on malnourished children populations in developing countries.
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Results of the study show that “good” consumers of the formula (intake ≥50% of recommended dose) throughout both phases of the study, significantly improved their height and weight without increase in their BMI. A dose-response was found between the amount of formula consumed/kg and improvement in height and weight. No serious adverse events were reported.
The Pro-Up nutritional formula is a result of years of scientific research studying the interaction between nutrition and growth and the mechanisms responsible for driving height gain, while taking into account the well-established association between adequate nutrition, linear growth and weight gain - which demands balanced nutrition and sufficient calories as prerequisites for linear growth. The formula therefore contains high quality whey protein, amino acids, vitamins and minerals. It is low in fat and high in protein compared with other existing products.
Recently, NG Solutions entered into a licensing agreement with GlaxoSmithKline Consumer Healthcare Pte Ltd (GSK) for producing and marketing the nutritional formula in India and additional territories, where it is called Horlicks Growth+.
Prof. Moshe Phillip, Director of the Institute of Endocrinology and Diabetes at Schneider Children’s Medical Center and CEO of NG Solutions, said, “We are pleased that the second phase of the clinical trial showed a continued improvement in height and weight in short and lean children, without an increase in BMI. This indicates that our nutritional formula, a result of extensive scientific research, is able to drive growth and children. Underweight and short children are prevalent not only in low-income countries, but also in developed countries and in middle income populations. Our product can help optimize children nutrition throughout the globe, and help solve one of the major factors influencing children health and their ability to thrive. It is an exclusive, safe solution for healthy short and lean children who don’t meet requirements for growth hormone treatment or don’t wish to use it.”