Collaborative clinical studies are the bedrock of our commitment to safe and healthy nutrition for all – generating knowledge about how we can support special needs.
Mapping the nutritional potential of dairy ingredients
The human need for nutrition changes through life, from infancy to old age and during periods of ill health. At Arla Foods Ingredients, we play a part in addressing those needs by mapping the nutritional potential of milk and whey and applying that knowledge to our ingredient solutions.
Partnerships with independent research institutes are essential through all these efforts. Working together, we identify new areas where our ingredients could make a difference in foods for special needs and secure documentation through collaborative clinical studies.
During 2022, our clinical studies had infant and elderly nutrition, type 2 diabetes and kidney diets in focus.
Infant growth and metabolism study
A clinical study to evaluate the effect of various infant formulas on growth and metabolism has followed a total of 320 infants from the age of four to eight weeks and up to three years.
The study has compared a protein-reduced infant formula enriched with alphalactalbumin with another protein-reduced formula, a standard formula and breast feeding. The purpose was to determine whether the growth and metabolism of infants who received the alpha-lactalbumin-enriched formula was more similar to that of breast-fed infants.
Previous research suggests that infant formula with a protein content and amino acid composition closer to that of breast milk may reduce the risk of childhood overweight. There may also be potential to reduce overweight, obesity and related health challenges in later life.
Arla Foods Ingredients has sponsored the study, with Skåne University Hospital, University of California Davis and Umeå University as research collaborators. The initial findings are expected to be published in the coming months.
Infant formula is an important source of nutrition for infants without access to breast milk. Where breast milk is available, Arla Foods Ingredients follows the World Health Organization recommendation for exclusive breastfeeding during the first six months of an infant’s life and partial breast-feeding up to the age of two in combination with appropriate complementary foods.
Safety study of partial hydrolysates
The European Food Safety Authority enforced a new regulation in 2022 that requires clinical safety documentation of all hydrolysed proteins used in infant formulas. Against this background, we have partnered with Umeå University and Lund University in Sweden to conduct a clinical study of two partial hydrolysates.
Recruitment of an estimated 312 healthy infants aged from four to eight weeks is currently in progress. For minimum three months, the infants will receive a standard infant formula or one of two infant formulas based on the partial hydrolysates. Only infants without access to breast milk will be included in the formula-fed groups. A reference group will comprise breast-fed infants.
The objective is to measure the infants’ weight at five months of age along with length and head circumference as other indicators of normal growth. Markers of gastrointestinal comfort, allergy and inflammatory response will also be evaluated.
The study is scheduled for completion in mid-2026.
Vaccine response in the elderly
Preliminary research suggests that osteopontin (OPN) plays a part in the development of infant immune func- tions. But no clinical study has yet investigated whether the whey protein can support the immune response of another vulnerable consumer group – the elderly.
In 2022, we initiated a clinical study with Dutch clinical research organisation NIZO to document the potential effect of OPN on the immune response of elderly subjects to a vaccine – an endpoint recommended by the Europe- an Food Safety Authority for the scientific substantiation of claims related to immune defence against pathogens.
Over the course of 14 weeks, the 140 participants – all healthy adults over the age of 65 – will receive a daily dietary supplement with or without OPN. Following vaccination against hepatitis B towards the end of the study, the immune response will be measured by analysing the level of antibodies in blood samples.
To our knowledge, the OPN study is the first in adults. If a positive effect on immune response is shown, then there could be basis for further studies of OPN’s potential role in slowing the decline of the immune system during ageing.
Study of blood glucose response
Previous studies of people with type 2 diabetes have shown that whey protein can reduce blood glucose fluctuations after a meal. A recently completed PhD study conducted at Newcastle University in the UK has now investigated the effect of consuming a ready-to-drink shot with just 15g whey protein in adults between the age of 40 and 60, all with type 2 diabetes.
The 18 participants tested the protein-enriched shot for seven days and a control drink for seven days, consuming them three times daily prior to each main meal. All were fitted with a continuous blood glucose monitoring sensor throughout the study.
The results showed that, when participants received the protein-enriched shot, their glucose levels were closer to the recommended guidelines – despite the very low protein dose. In fact, they spent two more hours a day in a healthy glucose range than when they consumed the control. This positive outcome suggests that a convenient whey protein premeal shot could benefit type 2 diabetes management.
Arla Foods Ingredients has provided funding for the study.
Muscle maintenance in CKD patients
More than 800 million people globally are estimated to have chronic kidney disease (CKD), according to the American Society of Nephrology. Depending on the severity of the disease, CKD patients may be advised to minimise their intake of phosphorousrich foods such as meat and dairy products to avoid health risks related to mineral build-up in the kidneys. Because these foods are primary sources of dietary protein, people on a renal diet are at higher risk of protein malnutrition and subsequent loss of muscle mass.
A clinical study at Maastricht University in the Nether- lands is investigating whether beta-lactoglobulin (BLG) – a novel and patent-protected whey protein ingredient rich in essential amino acids but very low in phosphorous – can help maintain muscle mass in CKD patients.
Planned to run for six months, the study will recruit 20 patients with advanced CKD but not yet in need of dialysis. Participants will receive a BLG-supplemented drink on alternating weeks, while their muscle synthesis will be measured throughout.
We are providing BLG and funding for the study.
Milk matters in malnutrition
Arla Foods Ingredients supports the research of Project Peanut Butter and Washington University in St. Louis to identify the most impactful ingredients in ready-to-use supplementary foods (RUSF) for malnourished children. In October, Professor Mark Manary and Dr Kevin Stephensen visited Denmark, where they presented the results of their Milk Matters clinical study.
Previous research had established that RUSF made with dairy ingredients improves child recovery from moderate acute malnutrition (MAM). The purpose of this study was to investigate why milk makes a difference by comparing the effect of various RUSF recipes made with milk and/or plant-based sources of protein and carbohydrate.
Over two years, the study recruited around 1,000 children aged six months to five years for the individually randomised, doubled blinded trial at ten feeding clinics in Sierra Leone. Recovery from MAM and potential changes in gut permeability, the intestinal microbiome and metabolome were followed during this time.
The results disprove ideas that the effect of milk ingredients could rest with their high digestibility and beneficial impact on gut bacteria. All the RUSF recipes were found to have a similar effect on gut health and the microbiome.
However, a difference was seen in the metabolome of children treated with the RUSF containing milk protein and carbohydrate. This suggests that the dairy ingredients activate different metabolic pathways – a possible clue to why milk matters in malnutrition treatment.
Arla Foods Ingredients provided the whey protein and permeate used for the study, which was also sponsored by the Danish Dairy Research Foundation.
* Smith et al. Thrice daily consumption of a novel, premeal shot containing a low dose of whey protein increases time in euglycemia during 7 days of free-living in individuals with type 2 diabetes. BMJ Open Diabetes Res Care. 2022 May;10(3):e002820.
