In 2014, Nutritional Growth (NG) Solutions, an Israeli developer of nutritional supplements, entered into a licensing agreement with GlaxoSmithKline Consumer Healthcare to produce its Pro-Up children’s growth formula in India and other territories. However, it wasn’t until September, five months after GSK launched the formula, that the agreement was made public.
In India, GSK is marketing the formula, which has clinical data showing its benefit to growth in short and lean pre-pubescent children, under the Horlicks Growth+ brand.
Now following a 12-month clinical trial testing the formula in children in an “affluent society”, NG Solutions has an eye on establishing agreements in other countries.
“We are looking for European partners to help market Pro-Up in Europe,” Liron Fendell, head of business development at NG Solutions, told NutraIngredients. It has been on-market in Israel since May 2015.
She confirmed that the company was looking to market Pro-Up via the retail channel, rather than through public healthcare services, but with the backing of healthcare professionals. She said this stemmed from Pro-Up’s status as a food/food supplement.
Pro-Up is formulated to help short and lean children to increase height and weight without an increase in BMI (body mass index).
In India, the need for such a supplement is clear: the prevalence of stunting is estimated at 48%, according to the 2014 Global Nutrition Report.
A first world problem?
But what about in Europe where obesity is the primary public health issue?
Fendell pointed out that 10% of all children in the developed world are below the 10th percentile for height, which means that at least 90% of their peers are taller than them. She said that at the Institute for Endocrinology and Diabetes at the Schneider Children’s Medical Center in Israel, about half of the 17,000 patients that pass through its doors each year complain about their height.
“Growth problems and short stature are very common reasons for doctors’ referrals, and still there is no medical solution, except growth hormone treatment in extreme cases,” she said.
She acknowledged that obesity was the bigger issue in the developed world, but explained that Pro-Up increases height “responsibly”, without a detrimental effect on weight.
“Although Pro-Up contains a large amount of energy, in studies, the children using it gained height and weight without an increase in BMI, thus indicating height gain with no obsegenic effect,” she said, adding, "We are still evaluating which claims could be made in Europe."
High protein, low fat formula
Pro-Up nutritional formula contains whey protein (28%), amino acids, carbohydrates (47%), vitamin A, vitamin C, vitamin D, iron and zinc.
While this doesn’t - on the face of it - appear to be a ground-breaking combination, Fendell explained that its ability to increase height without increasing BMI stems from the combination of ingredients and the dosage of each ingredient.
“Pro-Up contains a large amount of protein and small amounts of fats compared to other existing products. This formula was informed by years of scientific research around the stimulation of the growth plate in the long bone, responsible for driving height gain, and acknowledges the well established association between adequate nutrition, linear growth and weight gain - which demands balanced nutrition and sufficient calories as prerequisites for linear growth,” she explained.
No tall story
Pro-Up’s efficacy as a solution for supporting growth in children was recently confirmed in a one-year, two-phase trial led by professor Moshe Phillip, director of the Schneider Children’s Medical Center and CEO of NG Solutions. Whilst previous studies had focused on malnourished children in developing countries, this study focused on children in an affluent society.
200 healthy children aged 3-9 years with height and weight in the 10th percentile or less took part in the first phase - a double-blind placebo-controlled trial. The second phase was an open-label extension, in which all participants were invited to continue the study using the nutritional formula only.
129 of the first phase participants completed the open-labeled extension phase. Results showed that ‘good’ consumers of the formula (ie those who took 50% of more of the recommended dose) throughout both phases of the study significantly improved their height and weight without increasing their BMI. A dose-response was found between the amount of formula consumed/kg and improvement in height and weight.
“One year of a nutritional supplement was effective in promoting the linear growth of short and lean pre-pubertal children, with no change in body mass index status,” concluded the researchers, writing in the Journal of Pediatrics.
The Journal of Pediatrics
30 September 2016 (doi: 10.1016/j.jpeds.2016.08.100)
“Effect of Nutritional Supplementation on Growth in Short and Lean Prepubertal Children after 1 Year of Intervention”
Authors: Michal Yackobovitch-Gavan, PhD, Yael Lebenthal, MD, Liora Lazar, MD, Shlomit Shalitin, MD, Sharon Demol, MD, Ariel Tenenbaum, MD, Raanan Shamir, MD, and Moshe Phillip, MD