Investigating the effect of Plantago psyllium fiber supplementation on levels of cholesterol and inflammation in adolescents with obesity

INTERVENTION: This study was a randomized placebo‐controlled trial with a double‐blinded (to the participant and the investigator who gave the treatment) design. Randomization and allocation to trial group were done using computer random number generation. All participants were randomized into a 7 week intervention with either 10 g/day of psyllium (equating to 10 g of dietary fiber) Plantago psyllium powder (Kirkland signature ®, Lot 0294B12), or 10 g/day of rice flour placebo (Healthy Flours ® batch AB140119). In both groups, the dose was diluted in 250 ml of water, ingested immediately after dilution with intake of 250 ml of additional water, in the morning, before ingesting food. The dose of 10 g/day was adopted based on a review of the existing literature, as well as on the volume of fiber and placebo each dose would equate to, so as not to affect compliance with the study protocol. Both the psyllium and rice flour were packed in opaque bags without labeling the name only as A or B. Each dose was given daily by the blinded investigator. Adherence to dosing was monitored directly through a checklist and during the weekend through a photograph sent by the participant through What’sApp. Participants were advised to continue their normal eating and exercise patterns during the study period. Three dietary records were collected at baseline and at clinical assessment following the 7 week intervention. Each dietary report encompassed an itemized nutritional intake recorded during two school days and one weekend day. Nutritional intake was recorded using standard household measures, as well as the information from food labels where appropriate. At each visit during the dietary treatment CONDITION: Cardiovascular disease in adolescents with obesity ; Circulatory System ; Cardiovascular disease, atherosclerosis PRIMARY OUTCOME: ; 1. Anthropometric and biochemical markers measured using the following at baseline and 7 weeks:; 1.1. The height and weight of the child measured using a SECA stadiometer (to the nearest 0.1 cm) and a SECA scales (to the nearest 0.1 kg), and body mass index (BMI) was calculated as kilogram per square meter (kg/m2); 1.2. Waist circumference (WC) measured using Lufkin ® metallic tape (to the nearest 1mm); 1.3. LDL and HDL subclasses measured using a venous blood sample obtained after 12 h of fasting processed using the Lipoprint system (Quantimetrix); 1.4. IL‐6 measured using an ELISA assay of a venous blood sample was obtained after 12 h of fasting; INCLUSION CRITERIA: 1. Aged 15 to 19 years 2. =1 of the following cardiovascular risk factors: 2.1. Obesity, defined as a body mass index (BMI) for age more than 2 standard deviations above the median established in the World Health Organization (WHO) Child Growth Standards 2.2. Altered lipid profile, defined as: total cholesterol >70 mg/dl; LDL cholesterol >110 mg/dl; HDL cholesterol <40 mg/dl; fasting glucose >100 mg/dl; elevated triglycerides >90 mg/dl; or insulin resistance with Homeostatic Model Assessment of Insulin Resistance (HOMA IR) >3 3. Non‐smokers SECONDARY OUTCOME: ; Somatometric variables measured using the following at baseline and 7 weeks:; 1.1. Blood pressure measured using an Omron® digital baumanometer; 1.2. Glucose measured using a venous blood sample obtained after 12 h of fasting processed using enzymatic methods in an autoanalyzer (Spinreact‐Spinlab, Model 6002390‐412‐02); 1.3. Homeostatic Model Assessment of Insulin Resistance (HOMA IR) measured using an ELISA assay of a venous blood sample was obtained after 12 h of fasting; 1.4. Lipid profile measured using a venous blood sample obtained after 12 h of fasting processed using enzymatic methods in an autoanalyzer (Spinreact‐Spinlab, Model 6002390‐412‐02); 1.5. The atherogenic index (AI) calculated as total cholesterol/HDL‐C using measurements from a venous blood sample obtained after 12 h of fasting processed using enzymatic methods in an autoanalyzer (Spinreact‐Spinlab, Model 6002390‐412‐02) and the Lipoprint system (Quantimetrix);