CLINICAL TRIALS

As part of the Eat2BeNICE Project, we are conducting studies that will determine the effect of four nutritional interventions on reducing impulsivity, compulsivity, and antisocial behaviour/aggression in the short and long term in four comprehensive clinical trials.

The interventions cover much of the lifespan; we are testing separate age groups. For each age group, we fit the interventions so that they are the most relevant and more appropriate for the characteristics of the age group. For example, in adolescents, we are testing the effects of vitamin-mineral supplements as this fits this age-group much better than intensive diets. All trials are aimed to recruit an equal amount of men and women. Furthermore, our measurements take place prior, during, directly after treatment and at the follow-up to test for short and long-term effects. Blood biomarkers and microbiome/(epi-) genetic assessments are screened at two-time points (pre-treatment and directly after treatment) and 7-days nutritional intake and physical activity are monitored.

Four clinical trials are being conducted with the following aims:

  1. To determine the short- and long-term effects of a personalized elimination diet (ED) versus a standardized diet according to the World Health Organization (WHO) health guidelines.
  2. To determine the double-blind placebo-controlled and open-label effects of broad-spectrum supplementation.
  3. To determine the double-blind placebo-controlled and open-label effects of probiotics.
  4. To determine the short- and long-term effects of an energy-restricted Mediterranean diet combined with physical activity and behavioural treatment versus an unrestricted caloric Mediterranean diet on overweight adults.
  5. To integrate the data collected in all 4 clinical trials to identify demographic (gender, age, socio-economic status) and clinical predictors and mediators of response to the different nutritional interventions.