Study design and dietary supplementation regimen
obese, overweight, Diabetes
OBESE, DIABETES
The present study was a randomised double-blind parallel-group placebo-controlled phase III trial performed at the Institute of Endocrinology, Havana, Cuba, in overweight and obese adults who met the selection criteria.After an initial evaluation, all subjects who met the eligibility criteria and wanted to participate in the study were enrolled consecutively. The study included 160 subjects who were administered Obex® or placebo (4 g sachets) twice daily for 6 months (24 weeks). In addition, non-pharmacological treatment consisting of lifestyle changes (physical activity and hygiene, and dietary measures) was prescribed.All subjects received advice and information regarding diet and nutrition at the Dietetic Department of the Diabetes Care Centre of the Institute of Endocrinology, where their diets were drawn up based on their daily calorie intake requirement per kilogram body weight and their level of physical activity. Individuals were provided with diets with the following proportion of nutrients: 55–60% carbohydrates, 15–20% protein, and 20% fat. Diets ranged from 1200 to 1500 cal [Several interim assessments were performed at 1.5, 3.0, and 4.5 months, including physical examination, anthropometric measurements (weight, height, waist, and hip circumference), physical activity through the IPAQ questionnaire [Randomisation within the study was designed using a computerised random number generator. All personnel involved in the study remained unaware of the correspondence between the codes and the content of the sachets. The treatments used for the study (Obex® and placebo) were provided by Laboratorios Catalysis, labeled with the randomisation code only. Code-to-sachet content associations were kept in a sealed envelope under the custody of the Head of the Research Methodology Department of the Institute of Endocrinology. Seal and envelope integrity was checked every three months. At the end of the study, the envelope was opened.Individual assessment of response was performed after three and six months of treatment. The complete success of weight and waist circumference reduction was considered to be when participants achieved a ≥ 5% reduction in both weight and waist circumference relative to the baseline value; partial success was when subjects achieved a ≥ 5% reduction in either of the two main anthropometric measurements (weight or waist circumference), and failure was considered to be when subjects did not achieve a ≥ 5% reduction in either weight or waist circumference or when an increase in both parameters was observed.At 12 weeks, subjects in both groups who had a reduction ≥ 5% of their body weight and waist circumference were categorised as early responders and continued participating in the study for up to 24 weeks. Once the optimal early response criterion was identified, subjects were classified as early responders (ERs) or early non-responders (ENRs) [The study was monitored by the National Coordinating Centre for Clinical Trials (Centro Nacional Coordinador de Ensayos Clínicos, CENCEC). The clinical trial began in November 2018 (first person in) and lasted until June 2019 (last person completed).