Participants
sepsis, eating disorders, prediabetes, thyroid dysfunction, overweight, hypo-, acromegaly, type 2 diabetes, hypersensitivity
SEPSIS, OBESE, DISEASE, TYPE 1 DIABETES, CHRONIC DISEASES, DISORDERS, PREDIABETES, THYROID DYSFUNCTION, HYPERTHYROIDISM, HYPERCORTISOLISM, INSULIN RESISTANCE, ASYMPTOMATIC HYPOGLYCAEMIA, HYPERSENSITIVITY, ACROMEGALY, TYPE 2 DIABETES, DISEASES
Subjects were recruited through written advertisements contained in brochures produced for the study. The clinical trial was also promoted through direct communication and via opportunistic population screening in overweight and obese subjects.Participants were included if they were aged 20–60 years, had a BMI ≥ 25.0 kg/mParticipants with any of the most significant systemic, inflammatory or chronic diseases were excluded that were likely to affect study endpoints, as well as a history of or current condition of neurological or psychological disease, including eating disorders or substance use disorders. Participants who took oral or injectable contraceptives and women who were pregnant or breastfeeding were also excluded. Likewise, those who were shown to have thyroid dysfunction (hypo- or hyperthyroidism), type 1 diabetes, type 2 diabetes or prediabetes treated with oral hypoglycaemic agents, as well as those with any of the following characteristics: diseases manifesting insulin resistance (IR) (e.g. acromegaly and endogenous hypercortisolism), sepsis, use of medications that affect weight in the last 3 months, inability to follow instructions, symptomatic hypoglycaemia in the last month, known hypersensitivity to any of the formulation components, use of immunosuppressive drugs in the previous 5 years or having abused alcohol/drugs, were also excluded from the study. Individuals who used steroids, anti-inflammatory medications, multivitamins and/or antioxidants were not allowed.Patients who did not complete the minimum treatment time (three months) were also excluded. In the case of subjects who completed treatment for at least three months but subsequently discontinued treatment, only the three-month period in which the clinical trial groups were compared was taken into account for analysis.