Evaluating the effect of an energy-restricted anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response in younger adults with obesity: Study protocol for a randomized controlled trial

Introduction: Low-grade chronic inflammation is associated with obesity and related cardiometabolic disorders, such as cardiovascular diseases, type 2 diabetes, and some types of cancer. A growing body of evidence suggests that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. We are aiming to evaluate the effect of an energy-restricted anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors, and immune system response among younger adults with obesity. Methods: A two-arm, parallel design randomized controlled trial will be conducted in Croatia among 220 adults with obesity aged 18–50 years. Following baseline assessments, participants will be randomized into the intervention or control group in a 1:1 ratio. A nutritional intervention based on an energy-restricted anti-inflammatory diet (low-glycemic, low in omega-6, rich in omega-3 fatty acids, spices, herbs) will be compared with an isocaloric standard diet (55–60 % carbohydrates, 25–30 % fat, 15–20 % protein). The inflammatory potential of the diet will be assessed with the Dietary Inflammatory Index®. The change in body weight from baseline to the week 24 will be the main outcome measure. Secondary outcomes will include changes in body composition, cardiometabolic parameters, and the impact of the anti-inflammatory diet on immune system response and thyroid function. Conclusion: If the energy-restricted anti-inflammatory diet is found to be effective in the management of obesity, it has the potential to be implemented into management for reducing obesity and related chronic non-communicable disease in younger adults