Gluten Does Not Induce Gastrointestinal Symptoms in Healthy Volunteers: A Double-Blind Randomized Placebo Trial

Abstract:

Although the gluten-free diet (GFD) is the best treatment for clinical gluten sensitivity (GS) (eg, celiac disease [CD], non-celiac gluten sensitivity [NCGS]), scientific opinion supports that gluten is safe for the general population. However, celebrity/athletic endorsement of the GFD has cultivated an image of gluten as "unhealthy."

“Lifestylers,” “free from,” or “people who avoid gluten” are individuals who avoid gluten as a lifestyle choice. American market research found that 44% of people buy gluten-free food for reasons other than GS, and that 65% believe that a GFD is generally healthier. This trend has driven the worldwide gluten-free industry from values of $1.7 billion in 2011 to $3.5 billion in 2016, and it is forecast to reach $4.7 billion in 2020.

The surge in gluten-free popularity has also encouraged an opposing belief that it is a “fad” diet. This is unfortunate for people with CD/NCGS, who express that they are not taken seriously in restaurants, and even face dismissive attitudes from nonspecialist clinicians. 

The drawing of a clear line between those who do and do not benefit from a GFD is needed to ground public and clinical perspective on these issues. For this reason, we undertook the first double-blind randomized controlled trial (DRCT) of gluten (via gluten-containing flour) in healthy controls, hypothesizing it would not cause any symptoms.