Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

Abstract

Background: Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.Approach: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants,(3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples.Conclusions: By sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both trials were registered in the Clinical Trials Register

Nutrition, Behavior, and the Criminal Justice System: What Took so Long? An Interview with Dr. Stephen J. Schoenthaler

“…Zaalberg essentially replicated Gesch, and found significant reductions in reported rule-breaking incidents in the supplement group vs. placebo [138]. Gast's trials looked at nutritional supplementation and aggression in two different populations-long-stay psychiatric inpatients and people with intellectual disabilities [139]. Gesch used what was essentially a basic multivitamin-mineral with modest levels of omega-3 fatty acids and some gamma-linolenic acid, while Gast used slightly more omega-3 fatty acids along with a similar multivitamin.…”

Nutritional Criminology: Why the Emerging Research on Ultra-Processed Food Matters to Health and Justice

“…In two randomized controlled trials involving the administration of a vitamin-mineral supplement to inmates in correctional facilities, Schoenthaler reported significant reductions in rule violations among subjects consuming the supplement [101,102]. These studies, since replicated internationally in diverse populations in confinement, indicate that basic multi-vitamin/mineral and modest omega-3 fatty acid supplementation might play a helpful role in reducing the frequency of disciplinary offenses [103], rule-breaking incidents [104], and aggression [105]. An ongoing study in Australia is evaluating the potential of omega-3 fatty acid supplementation to lower aggression among inmates within correctional facilities [106].…”

Neurolaw: Revisiting Huberty v. McDonald’s through the Lens of Nutritional Criminology and Food Crime

“…Consumption of these foods (use of the word 'food' in reference to ultra-processed products is debated (Schoenthaler and Beginning in the 1980s, researchers began reporting on quasi-experimental dietary intervention trials in correctional settings-removing ultra-processed foods and replacing them with less-processed foods lower in sugar and higher in polyphenols and fiberconcluding that the changes were producing positive outcomes, including decreased antisocial behavior (Schoenthaler 1984;Schoenthaler and Bier 1985;Logan and Schoenthaler 2023). These were followed up with better-designed, but more reductionist, nutritional supplement intervention trials (vs. placebo), again demonstrating that nutrients can improve antisocial behavior, rule violations, aggression, and/or violence, in correctional or institutional settings (Gesch et al 2002;Zaalberg et al 2010;de Bles et al 2022;S. Schoenthaler et al 2023).…”