In this double-blind study of 22 hyperactive children, Levy put them on an elimination diet for four weeks and then challenged them with Yellow 5. She reported that their improvement in the first four weeks on the diet was significant, but there was no significant deterioration from a challenge with Yellow 5 except for a “subgroup” of the children.
- The tests for hyperactivity were done the day AFTER the challenge period.
- The “challenges” were via cookies — and each cookie contained only ONE mg Yellow 5. All five cookies, then, provided only 5 mg Yellow 5, which is just about what you would get in 1-1/2 ounces (44 ml, or a couple of swallows) of Sunny D Tangerine-Strawberry punch (See Stevens 2014, Table 3)
Surprisingly, the mothers of some of the children did report more symptoms during the challenge periods, creating the “subgroup” of very sensitive children.
In a followup study, Levy took 8 children and challenged them with an even smaller amount of the same dye — 4 cookies per day with ONE mg each. One of the children dropped out because his parents claimed he became worse after eating the challenge cookies. This left only 7 children, and although Levy actually documents an average behavioral score of 2.6 points higher for the challenges, it did not quite reach significance with such a small sample.