Randomized Controlled Trial of a Natural Whole Food Diet versus Habitual Diet for Crohn's Disease: Is Diet Quality the Key?
Abstract
BACKGROUND & AIMS
Diets can help induce remission in patients with Crohn's disease (CD). However, given inconsistent recommendations across purportedly beneficial anti-inflammatory diets and prior studies highlighting benefits of plant-based diet patterns, we hypothesized that the benefit of diet therapy stems from the overall "healthfulness" of diet patterns.
METHODS
In a pragmatic randomized controlled trial, adults with mild-to-moderate CD were assigned to receive guidance on a natural whole food diet that comprised principles of a healthful diet versus continuation of one's habitual diet. Primary outcomes included clinical remission and change in calprotectin in weeks 4 and 8. Secondary outcomes included nutritional parameters (nutrient and energy intake, body composition, metabolic rate) and adverse events. Healthy Eating Index (HEI) served as a surrogate of diet quality and adherence.
RESULTS
Twenty-eight participants with active CD were randomized. In intention-to-treat analysis, whole food diet led to overall greater clinical remission (odds ratio [OR] 1.41; 95% CI 1.03-1.93; P=0.03) and similar change in calprotectin. In per protocol analysis, adherence to a healthful diet was associated with clinical remission (OR 1.18; 95% CI 1.02-1.38; P=0.03) and change in calprotectin (-234; 95% CI -465 to -3; P=0.047). There was no increased risk of nutritional deficiency or reported adverse events.
CONCLUSION
Following a natural whole food diet based on principles of a…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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