Effects of an elimination diet and a healthy diet in children with Attention-Deficit/Hyperactivity Disorder: 1-Year prospective follow-up of a two-arm randomized, controlled study (TRACE study).
Study Goal
The researchers aimed to compare the long-term maintenance effects and feasibility of an Elimination Diet (ED) versus a Healthy Diet (HD) in reducing ADHD symptoms in children.
Results Summary
The study found that after 1 year, the HD (+CAU) trajectory showed better improvement (64%) compared to the ED (+CAU) trajectory (47%) and had comparable outcomes to non-randomized CAU. HD also reduced psychostimulant use without negatively impacting long-term outcomes.
Population
Children aged 5-12 years with ADHD.
Effective Dosage
Not specified
Duration
5 weeks of initial treatment, followed by 1-year follow-up.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Elimination Diet (ED) | decrease | symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) | children (5-12 years) with ADHD | - | may be effective in reducing | #1 |
Healthy Diet (HD) | decrease | symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) | children (5-12 years) with ADHD | - | may be effective in reducing | #2 |
Elimination Diet (ED) (+CAU) trajectory | decrease | improvement based on both parent and teacher ratings on ADHD and dysregulation problems | children (5-12 years) with ADHD | 47% | fewer participants showed (partial) improvement | #3 |
Healthy Diet (HD) (+CAU) trajectory | increase | improvement based on both parent and teacher ratings on ADHD and dysregulation problems | children (5-12 years) with ADHD | 64% | showed (partial) improvement | #4 |
Healthy Diet (HD) (+CAU) trajectory | no change | 1-year outcomes | children (5-12 years) with ADHD | - | had comparable 1-year outcomes | #5 |
Elimination Diet (ED) (+CAU) trajectory | no change | 1-year outcomes | children (5-12 years) with ADHD | - | did not have comparable 1-year outcomes | #6 |
Elimination Diet (ED) (+CAU) trajectory | no change | secondary outcomes (e.g. health, parental stress) | children (5-12 years) with ADHD | - | did not differ | #7 |
Healthy Diet (HD) (+CAU) trajectory | no change | secondary outcomes (e.g. health, parental stress) | children (5-12 years) with ADHD | - | did not differ | #8 |
Elimination Diet (ED) (+CAU) trajectory | decrease | psychostimulant use | children (5-12 years) with ADHD | 38% | prevalence was lower | #9 |
Healthy Diet (HD) (+CAU) trajectory | decrease | psychostimulant use | children (5-12 years) with ADHD | 45% | prevalence was lower | #10 |
Care as Usual (CAU) trajectory | neutral | psychostimulant use | children (5-12 years) with ADHD | 78% | prevalence was | #11 |
Initial 5-week treatment with HD and if needed/preferred followed by CAU | decrease | psychostimulant use | children (5-12 years) with ADHD | - | may reduce | #12 |
Initial 5-week treatment with HD and if needed/preferred followed by CAU | no change | 1-year outcomes | children (5-12 years) with ADHD | - | without negatively impacting | #13 |
BACKGROUND: An Elimination Diet (ED) or Healthy Diet (HD) may be effective in reducing symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), but long-term maintenance effects and feasibility have never been examined. METHODS: One-year prospective follow-up of a sample of 165 children (5-12 years) with ADHD randomized (unblinded; 1:1) to 5 weeks treatment with either ED (N = 84) or HD (N = 81) and a non-randomized comparator arm including 58 children being treated with Care as Usual (CAU). Dietary participants were allowed to add or switch to CAU treatment after 5 weeks. The primary outcome was a 5-point ordinal measure of improvement based on both parent and teacher ratings on ADHD and dysregulation problems, determined after 1 year prospective follow-up. Ordinal regression analyses and linear mixed models analyses were conducted on an intention to treat basis. In addition, as-treated analyses were performed. The trial is closed and registered in the Dutch trial registry, number NL5324. RESULTS: At 1 year follow-up, 24% of the participants still complied with the ED and 37% still complied with the HD. In the ED (+CAU) trajectory, fewer participants showed (partial) improvement after 1-year prospective follow-up compared to the HD (+CAU) trajectory (47% vs. 64%, χ2 (4, N = 152) = 11.97, p = 0.018). The HD (+CAU) - but not ED (+CAU) - trajectory had comparable 1-year outcomes compared to the non-randomized CAU-trajectory. Results for secondary outcomes (e.g. health, parental stress) did not differ between the ED (+CAU) and HD (+CAU) trajectories. The prevalence of psychostimulant use was lower in the ED (+CAU) and HD (+CAU) trajectories compared to the non-randomized CAU-trajectory (38%, 45%, 78%, respectively). Predictors for long-term benefit from dietary treatments included high initial severity of ADHD problems, low severity of emotional problems and sufficient parental mental resources. CONCLUSIONS: In line with the short-term effects, prospective 1-year follow-up outcomes are in favor of treatment with HD and not ED. Initial 5-week treatment with HD and if needed/preferred followed by CAU may reduce psychostimulant use without negatively impacting 1-year outcomes.