Nutritional formulation to enhance growth in children

By Kevin Robinson 8-Jun-2017

Dr Kevin Robinson recently met with Liron Fendell, Head of Business Development at NG Solutions, to learn more about the company’s clinically proven nutrition products

Exploring the interaction between nutrition and growth in premature infants, infants, toddlers, children and adolescents, NG Solutions, established in 2014, is dedicated to developing leading-edge innovations in the field of paediatric nutrition that address current unmet needs of patients worldwide.

The need

Children’s height is a major concern for parents around the world. This is especially true, but not exclusively, when children are under the 10th percentile for height. Documentary evidence suggests that short people consistently report worse health and more frequent illness; short stature is associated with inferior perceived personal characteristics; and short teens are less likely to participate in social activities such as athletics, school clubs and dating.

Less scientifically, it is also suggested that short men earn less money than tall men and that being short is associated with lower levels of attractiveness in romantic relations.

Currently, the only existing solution to the condition is human growth hormone (HGH) therapy, which is only applicable in radical cases, involves daily injections and has possible side-effects. NG Solution’s formula, developed with the Schneider Children’s Medical Center of Israel, may provide a nutritional alternative.

NGS founders Prof Moshe Phillip and Prof. Raanan Shamir have long focused on nutrition-induced catch-up growth in children and have published extensively on the topic. In 2010, they elucidated the effects of specific amino acids — such as arginine — and macro and micronutrients that were required for growth.

Clinical study

Formulated into a powder-based dosage form (Figure 1), the company has conducted a prospective, randomised, double-blind, placebo-controlled clinical trial to examine the effects of Pro-Up in 200 children. Results of the trial, published in the Journal of Pediatrics in 2014 and 2016, show a clear increase in height and weight in children who consumed the nutritional formula, without increase in body mass index (BMI), suggesting linear growth without an obesogenic affect.

The formula

The formula

The first phase of the trial was a double-blind placebo-controlled trial, comprising 200 healthy children aged 3–9 years with heights and weights below the 10th percentile. The second 6–12-month phase was an open-label extension, using the nutritional formula only, and included 150 of the first-phase participants, 129 of which completed the 6-month extension.

The clinical study focused on children in an affluent society with low — but within the normal range of — weight and height, whereas most other existing studies have focused on malnourished children populations in developing countries, and did not include a placebo-control blinded arm.

Results of the study showed that “good” consumers of the formula (intake >50% of recommended dose) throughout both phases of the study significantly improved their height and weight without a concomitant increase in their BMI. A dose-response was found between the amount of formula consumed/kg and improvement in height and weight (Figure 2). No serious adverse events were reported.

Significant change in height

Significant change in height

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. 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 to optimise children’s nutrition around the world 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,” he added.

Market opportunities

NG Solutions believes its product has a unique selling proposition: it’s proven to promote growth in prepubescent children; it’s low in fat and high in protein, compared with existing products; and has no effect on BMI. From an intellectual property (IP) perspective, the company’s IP is protected by pending patent applications that cover the compound’s composition and its uses.

Regulated as a dietary supplement and sold as a direct-to-consumer product, Pro-Up is currently available in Israel and has delivered good market penetration in the first 2 years. In addition, NG Solutions has recently entered into a licensing agreement with GlaxoSmithKline Consumer Healthcare Pte Ltd (GSK) to produce and market the nutritional formula in India and additional territories, where it is called Horlicks Growth+.

Now working on a gender-specific teenage formulation and investigating line extensions such as sports nutrition versions, the company stresses that its aim is to maximise the growth potential of children — by complementing their genetic metabolism or making up for nutritional deficiencies — and not to induce “extra” height.

Adequate nutrition is required to optimise children’s growth, and our nutritional supplement is an innovative formula offering a feasible, effective and safe approach to promote the growth and weight gain of healthy short and lean children worldwide.

Reference

1. M. Yackobovitch-Gavan, et al. “Effect of Nutritional Supplementation on Growth in Short and Lean Prepubertal Children after 1 Year of Intervention,” J. Pediatrics 179, 154–159 (2016).

Companies