The brain health of millions of malnourished children stands to benefit following changes to global guidelines for the formulation of ready-to-eat therapeutic food – the standard treatment for severe malnutrition in developing countries.
Results of a major clinical trial in Africa led by Mark Manary, MD, professor of pediatrics at Washington University School of Medicine in St. Louis, prompted the change. The trial, in Malawi in sub-Saharan Africa, showed that altering the fatty acid composition of nutrient-dense therapeutic food can improve cognition and boost IQ scores of severely malnourished children, while also enhancing language proficiency and motor skills.
Specifically, Manary and his WashU colleagues showed that adding an omega-3 fatty acid called docosahexaenoic acid (DHA) to the therapeutic food and reducing the amount of linoleic acid – a polyunsaturated omega-6 fatty acid – provided the most benefit to malnourished children. DHA is a nutritional supplement that has become popular in the U.S. and is touted as an addition to some types of yogurt, milk and infant formula.
Based on these findings, a global commission that sets food-safety standards adopted new guidelines calling for ready-to-eat therapeutic food (RUTF) to be reformulated to include DHA and to lessen the amount of linoleic acid.
“Imagine the effects of improving the brain development of millions of kids,” said Manary, the Helene B. Roberson Professor of Pediatrics. “Our ultimate mission was to change global policy, and that’s what we did. The children deserved nothing less.”
The new guidelines went into effect in January and, while voluntary, are expected to be followed by makers of ready-to-eat-therapeutic food. They were approved in late 2022 at a meeting of international public health heavyweights on the Codex Alimentarius Commission, a group formed by the World Health Organization (WHO) and the U.N.’s Food and Agriculture Organization. The commission sets food-safety standards followed by most of the world’s nations, making it essentially the global equivalent of the U.S. Food and Drug Administration.
However, Manary’s scientifically backed pleas to reformulate RUTF almost went unheeded. The researchers had to fight for it.
“The brain is the most important organ in the body,” Manary said. “We could not take no as an answer when an opportunity existed to build a stronger brain and improve children’s lives.”
Millions of malnourished kids
Globally, more than 16 million children under age 5 suffer from severe acute malnutrition, and each year about 1 million children die from it. The condition is a form of starvation that causes excessive thinness or swelling of the body while also compromising organ systems, including the brain. More than two decades ago, Manary launched an effort in Africa to fight childhood malnutrition using a peanut butter-based therapeutic food fortified with micronutrients. The food requires no cooking or refrigeration, making it ideal for malnourished children, who often live in extreme poverty.
The food is distributed in foil packets to children suffering from severe malnutrition but who aren’t sick enough to be hospitalized. Research by Manary and others has shown that the therapeutic food has saved the lives of millions of malnourished children, who have recovered at rates of 85% to 90%. But severe malnutrition often causes cognitive problems that have not been shown to markedly improve with the therapeutic food. So, Manary and colleagues have continued their research in hopes of finding ways to also prevent or lessen cognitive problems associated with severe malnutrition.
The trial in Malawi involved malnourished children ages 6 months to 5 years, and results were so dramatic that experts in childhood malnutrition, led by Manary, decided to petition Codex Alimentarius to develop international guidelines that call for a reformulation of RUTF.
Sleepless weekend changes global policy
Manary, online from St. Louis, presented the case for changing RUTF to the Codex Alimentarius Commission in November 2021.
“Reformulating and standardizing ready-to-use therapeutic foods enriched with DHA and reduced omega-6 will help severely malnourished kids reach their neurocognitive potential,” Manary told the commission. Also in virtual attendance was Kevin Stephenson, MD, a Washington University instructor in medicine who has been essential to the research since 2009; and key collaborator J. Thomas Brenna, PhD, a nutritional chemist and professor of pediatrics at the University of Texas at Austin.
Despite the clear evidence, benefits and minimal costs, the commission’s reaction to the researchers’ findings was “lukewarm,” Manary said.
“No one overtly objected to our recommendation, but our appeal seemed like a smaller detail in the larger process of examining data and ingredients in therapeutic foods,” he said.
A gavel slammed on a desk.
The issue was tabled.
It was over.
Or not. Minutes later, the researchers initiated an emergency Zoom meeting.
Manary and Stephenson rallied their colleagues, emphasizing that the Codex Alimentarius meeting would continue for a few more days. “Technically, the issue isn’t done,” Stephenson told his peers. “But if we don’t act quickly, it will be done.”
Added Manary: “We’re going to do everything we can. Helping restore children’s brain development is too important to dismiss.”
During the Zoom meeting, Stephenson suggested the team create a petition they would email to global leaders in pediatrics, nutrition, global health, neuroscience and fatty acid biochemistry. The researchers went on to cold-call dozens of nations’ representatives on the commission, physicians, scientists, as well as leaders of child advocacy and health groups, including the United Nations Children’s Fund, also known as UNICEF, a U.N. agency assigned with distributing humanitarian and developmental aid to children.
The researchers were determined to share details of the clinical trial so that anyone with sway would understand the need to make the changes in RUTF regarding DHA and omega-6.
The findings convinced the FDA and other nations’ food-safety agencies to call for Codex Alimentarius to make a change in RUTF guidelines. A petition labeled “urgent” was signed by 75 experts within days of its drafting. A UNICEF representative further bolstered the cause by reaching out to key Codex leaders.
All of this occurred over one sleepless weekend. It had to. The commission was scheduled to reconvene on the following Monday.
The advocacy work proved successful. Codex Alimentarius resurrected the issue.
At the reconvened meeting, Manary offered an impassioned plea: “All of us have a choice today to either help malnourished children or let a potentially lifesaving opportunity pass.”
Forty-five minutes later, a committee of Codex Alimentarius recommended reformulating RUTF to include DHA, and to lessen the fatty acid levels of omega-6. The new guidelines went into effect Jan. 1.
Additionally, the WHO formally adopted new guidelines for countries to enrich RUTF with DHA and to reduce the amount of linoleic acid.
“There was no question we had to persist to change policy,” Manary said. “Kids’ lives are at stake.”
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