The following is a summary of results obtained from a double-blinded, placebo-controlled human subject study on the Alcat test. Professor and researcher Judith Lukaszuk, RDN, LDN is a licensed dietitian in the state of Illinois. She holds a Master’s degree in nutrition and a Ph.D. in exercise physiology. Judith currently works at Northern Illinois University in DeKalb Illinois.

Effect of Alcat-Based Food Elimination on Inflammatory Markers, Body Composition, and Medical Symptoms

Research was conducted by Lukaszuk J, Shokrani M, Hoppensteadt J, and Umoren J in the spring of 2015 at Northern Illinois University on the Alcat test (Cell Science Systems- CSS).

The study is one of the first known to investigate the question of whether foods actually have an effect on total body inflammation. In the pre/post test double-blind study researchers did not know what protocol subjects would be on. Only CSS was aware of who was in the placebo and who was in the treatment group. Cell Science Systems provided lists of foods for subjects to avoid along and researchers provided guidance for what do during the study period.

The treatment group (n=87) got the correct list of foods to avoid, meaning what was in the red, orange, yellow, or blue columns. The placebo group (n=46) received a false list of foods to avoid. Neither the researchers nor the subjects knew what group they were in. The study was unblinded at the end and all subjects were provided with the correct list of their reactive foods.

Subjects followed a four-week elimination diet based on the Alcat results. Blood samples, body composition, and medical symptoms questionnaire (MSQ) were completed day 1 and day 30. A Disease Symptom Inventory (DSI) was completed to see who would qualify for the study; the entire DSI consists of 20 questions. Subjects had to have a “3” (a somewhat severe effect) on at least two of the DSI questions.

Researchers set out to recruit individuals with signs of inflammation present, not individuals who were healthy and symptom-free. For example, the initial DSI revealed individuals with gastroesophageal reflux disease (GERD), eczema, anxiety, and other signs that they may be having food intolerance issues.

After 30 days on the elimination protocol, the treatment group experienced a statistically significant decrease in serum amyloid A levels (SAA) from day 1 to day 30. Conversely inflammation and SAA scores increased for the placebo group. The results were statistically significant at the 0.001 level. These remarkable results indicate that there is a significant decrease in inflammation when an individual avoids foods to which they are intolerant. The study utilized the SAA level as it can be considered a more sensitive marker for systemic inflammation than C-reactive protein (CRP).

Weight and BMI also decreased during the study. When restricting any type or number of foods, an individual will be more aware of what they are eating, caloric intake will be reduced, and BMI will be expected to decrease. Although both groups in the current study lost weight, the treatment group had a much more significant BMI decrease then did the placebo group.

After the initial DSI was completed, an MSQ was administered looking at head, ears, eyes, nose, throat, overall wellbeing, energy level, joint pain, and basically how one feels overall. Individuals in the treatment group felt significantly better from day 1 to day 30. The placebo group had the benefit of feeling better but not nearly to the extent that the treatment group reported.

One particular individual with lung nodules of unknown origin ended up in the treatment group. MSQ at the beginning of the study was 160, a very high score that reflects a multitude of symptoms. At the end of the study his MSQ was 11, demonstrating that he felt exceptionally better. The individual took his Alcat results, laminated them, and took them to the grocery store, to restaurants, to any place in which he was going to eat. When he returned to the doctor’s office his physician asked what he was doing because his nodules were receding. He informed his physician that he was following the Alcat elimination diet; the physician instructed him to continue what he was doing as the nodules were diminishing.

The study also looked at myeloperoxidase (MPO), an enzyme used by immune cells (neutrophils, monocytes) during microbiocidal activity. Levels of MPO decreased in both the treatment and placebo groups. Interleukin-6 (IL-6) is an inflammatory cytokine that is supposed to “drive the boat” in the sense that where it goes, everything else follows. Although it did increase in the treatment group, it increased considerably more in the placebo group.

The treatment group had a more significant decline in body fat than the placebo group though both groups lost weight.

Researchers conclude that

• Elimination of inflammatory foods has a positive impact on SAA, BMI, and MSQ scores
• Avoiding reactive foods and adhering to Alcat results may positively influence inflammatory responses, body composition, and well-being.

All study subjects indicated (in a post-study interview) that they would continue to eliminate reactive foods (as designated on the Alcat test) because they felt so much better when avoiding those foods.

Transcript:

Dr. Lukaszuk

Now these are very exciting results from a study that we did for Alcat, Cell Science Corporation, last spring at Northern Illinois University. And it’s the first study that I know of that actually looked to see that foods that we are eating actually could have an effect on our total body inflammation. So just to give credit to my other researchers that helped me with this, Masih Shokrani is a medical lab research professor at NIU, and then we had some assistance from a graduate student, Jodi Hoppensteadt. And Josephine Umoren is also a nutrition professor at NIU. So it was a pre/posttest double blind study. I had no idea what the subjects were on.

Only Cell Science Corporation knew who was in the placebo, who was in the treatment. They sent us lists for the subjects to avoid, and we gave them guidance on what they needed to avoid for the study time. The treatment group got the correct list of foods to avoid, meaning what was in the red column, and their orange column, and their yellow column, as well as their blue. And the placebo group got a false list of foods to avoid. And they knew this up front, but it was unblinded at the very end of the study. That’s the only way you can do a double blind study is if they don’t know who’s in what group, and I don’t know who’s in what group. So they followed a four week elimination diet based on the Alcat results. They had their blood samples, body composition, and medical symptoms completed day one and day 30.

Just to give you an idea of who would qualify for this study, we did something called the disease symptom inventory, and they had to have a three on at least two of these. Now the DSI is about 20 questions, but when I shrunk it down to 20, you couldn’t read anything. So I figured it was good just to abbreviate it to give you an idea of some of the things that we were looking for. We weren’t looking for people that were totally healthy to come into the study. We wanted people with some inflammation present, some kind of GERD, or eczema, anxiety, something to tell us that they were having food intolerance issues. We had no trouble finding people.

So this is the exciting part. You can see that in the blue, the treatment group, from day 1 to day 2…day 2 is day 30. It’s two time points. But this is looking at SAA, which is systemic inflammation in the body. The treatment group decreased from day 1 to day 30 in their total body inflammation. This is huge. And the placebo group, the one that were following the incorrect list of foods, their inflammation actually increased, and this was at the 0.001 level. So very, very significant results to show that there was decreased inflammation when you stay away from foods that you have intolerances to.

Now what we would expect with a study is when you’re restricting any kind of foods, even it’s 5 or 10 foods or more in some cases, your BMI is going to go down. Once you become more aware of what you’re eating, typically your caloric intake drops and your BMI is going to drop. But you can see that the treatment group had a much more significant BMI drop than that of the placebo group.

Medical system questionnaire. This was after the disease symptom inventory form was given. And the MSQ looks at head, ears, eyes, nose, throat, overall well-being, energy level, joint pain, “How are you feeling?” And so what we saw with that is that people in the treatment group felt significantly better from time one to time two. Placebo group had a benefit in feeling better, but not nearly as much as the ones that were in the treatment group. Now just to pull out one person in particular…and there were probably about 10 of these people that I saw in the study.

The one gentleman came in with lung nodules, and they didn’t know what from, what have you, and he ended up in the treatment group in our study. And his MSQ, his medical system questionnaire score at the beginning of the study was like 160. He was not feeling good. It was very, very, very high. And at the end of the study, it was 11, which means that he felt so much better. So he felt so much better, he was so compliant, he laminated his card of foods. He carried it around with him everywhere.

Any time he went out to eat, he used it. Any time he went to the grocery store, he used it. And when he went back to the doctor, he said, “What are you doing? Your nodules are going away.” And so he said, “Well, I’m following this elimination diet from Alcat Testing.” And he said, “Whatever you’re doing, keep doing it.” He said, “Your nodules are going away.” So this guy was just so, so happy about his results, and said that he was going to follow it forever. So it was very, very cute.

So other things that we looked at, and this is really just showing a main effect for time. It was lower at time two than it was time one. This is myeloperoxidase. You see it a lot high in rheumatoid arthritis. It decreased in both groups. Interleukin-6, now that’s the inflammatory cytokine that’s supposed to drive the boat. Where it goes, everything else follows. And even though it did increase in the treatment group, it increased a lot more in the placebo group here. And then mean fat percent, of course, when they’re losing weight, they’re probably going to lose fat percent, or at least you would hope. And they did, in fact, lose fat percent. The treatment group had a more significant decline in fat percent than the placebo group.

So, very exciting. It showed elimination of inflammatory foods has a positive impact on SAA, BMI, and medical system questionnaire scores. And so Alcat results may actually positively influence inflammatory markers, body composition, and just how you feel. And I know that the people that I did interview, we interviewed everyone at the end of the study, said that they were going to continue eliminating those foods because they felt so much better when they stayed off of them.