Does Cheerios Lower Cholesterol?

Cheerios upped the ante this summer by advancing their "lowers cholesterol 4% in 6 weeks" claim to "lowers cholesterol 10% in one month."

The abstract for the study upon which this new claim is being made is:
Ready-to-eat Oat Cereal, as Part of a Reduced Energy Diet, Reduces Low-density Lipoprotein Cholesterol and Waist Circumference in Overweight and Obese Adults, FASEB.

The study is still unpublished. Results were presented in April of this year at the Experimental Biology Meeting in New Orleans.

Of note:

• The abstract shows 8.7% reduction, not 10% reduction.
  
• The 8.7% reduction was for LDL cholesterol.
  
• The 8.7% reduction was achieved not only by eating 3 cups of Cheerios a day, but by reducing calories (by ~500 calories/day) and by reducing fat intake.
  
• The control group (which did not eat Cheerios but ate the reduced calorie, low-fat diet) also experienced lower LDL cholesterol (4.3%) and lower total cholesterol (2.9%).
  
• The 8.7% reduction is, in fact, a 4.4% reduction when compared to control group.
  
• There was no difference between groups in weight loss, HDL cholesterol, or triglycerides.

The following point makes me question the researchers' motives:

• The control group didn't just not eat the Cheerios, but it consumed "low-fiber control foods." It would be interesting to see the fiber types and intakes of both groups, before and during the intervention. How much was the control group's fiber intake suppressed? (For the sake of a positive result?)

The reduction in cholesterol did not occur outside of the context of a reduced-calorie, reduced-fat diet. The FDA sent General Mills a warning letter in May, less than 3 weeks after the results of the above study were presented, addressing this point:

"[Your claim] leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low. Therefore, your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet."
- FDA Warning Letter to General Mills, Inc. 5/5/09

"[Cheerios] is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States."
- FDA Warning Letter to General Mills, Inc. 5/5/09

One conclusion you might draw from this study is that relative to a low-fiber diet (we don't know how low), Cheerios may reduce LDL cholesterol by ~4%. That's like saying you're going to study thirst; you withhold fluid from the control group, feed Coke to the intervention group, and find that Coke prevents thirst.

Not only was this study funded by General Mills, it was designed by their researchers - who knew exactly what they were doing when they set the parameters.
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