The aim of the experiment is to test the hypothesis that a daily dose of Symphadiol enhances weight loss in clinically obese individuals, compared with just using a calorie-controlled diet. It was decided to select men between the ages of 30 and 40 for the study. It was also decided to look at the impact of exercise in conjunction with Symphadiol.
The intended population of this study are all healthy (other than their obesity) obese male individuals who are sufficiently motivated to lose weight to join a diet network. The individuals must not be taking any medication, except that required for minor ailments.
In total 60 males were recruited between the ages of 30 and 40. Each participant was given a health check prior to the start of the study, their heights were recorded, and they received educational material and diet plans giving details of a calorie-restricted diet (2000 kcal), which they declared they would follow.
All the men attended weekly diet networks where they received support and encouragement from their fellow dieters and the clinical trial specialist nurse. Those individuals following an exercise regime also attended a gym and completed the equivalent of 30 minutes cycling (16 km) three times per week.
The 60 participants were distributed randomly to four experimental groups:
group 1: calorie-controlled diet and placebo.
group 2: calorie-controlled diet and Symphadiol.
group 3: exercise regime, calorie-controlled diet and placebo.
group 4: exercise regime, calorie-controlled diet and 35mg Symphadiol.
In this example, objective was to test the hypothesis that a daily dose of Symphadiol enhances weight loss in clinically obese individuals, compared with just using a calorie-controlled diet. In the experiment described above the independent variable is the treatment group (either Symphadiol treated or control) the patients are assigned to, while the dependent variable is the weight loss. Weight loss is the variable that will be measured.
In the Symphadiol trial, select appropriate group of participants and write two null hypotheses.