Reduction of small dense LDL and Il-6 after intervention with Plantago psyllium in adolescents with obesity: a parallel, double blind, randomized clinical trial.
- 2021-04-16
- European journal of pediatrics 180(8)
- Alma Patricia González
- Anaisa Flores-Ramírez
- Karla Paola Gutiérrez-Castro
- Claudia Luévano-Contreras
- Armando Gómez-Ojeda
- Gloria Patricia Sosa-Bustamante
- Russell Caccavello
- Juan Carlos Barrera-de León
- Ma Eugenia Garay-Sevilla
- Alejandro Gugliucci
- PubMed: 33861390
- DOI: 10.1007/s00431-021-04064-5
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 113
- Population
- 100 adolescents (50 in each group), 15 to 19 years with a body mass index of 29-34
- Methods
- Parallel, double blind, randomized clinical trial; participants assigned to Plantago psyllium or placebo (10g/day for 7 weeks)
- Blinding
- Double-blind
- Duration
- 7 weeks
- Large Human Trial
Obesity can lead children and adolescents to an increased cardiovascular disease (CVD) risk. A diet supplemented with Plantago psyllium has been shown to be effective in reducing LDL-C and IL-6 in adolescents. However, there are no studies that have explored small-dense LDL (sdLDL) or HDL subclasses. The aim of this study was to evaluate the impact of a fiber dietary intervention on LDL and HDL subclasses in adolescents with obesity. In this parallel, double blind, randomized clinical trial, the participants were assigned to Plantago psyllium or placebo (10g/day for 7 weeks). We randomized 113 participants, and evaluated and analyzed 100 adolescents (50 in each group), 15 to 19 years with a body mass index of 29-34. We measured biochemical markers LDL and HDL subclasses using the Lipoprint system (Quantimetrix) and IL-6 by ELISA. Post-treatment there was a decrease in sdLDL between the groups 2.0 (0-5.0) vs 1 (0-3.0) mg/dl (p = 0.004), IL-6 median 3.32 (1.24-5.96) vs 1.76 (0.54-3.28) pg/ml, p <0.0001. There were no differences in HDL subclasses and no adverse effects were reported in either group.Conclusions: Small dense LDL and IL-6 reduced in adolescents with obesity when consuming Plantago psyllium. This may be an early good strategy for the reduction of cardiovascular disease risk in this vulnerable population.Trial registration: ISRCTN # 14180431. Date assigned 24/08/2020 What is Known: • Supplementing the diet with Plantago psyllium lowers LDL-C levels. What is New: • First evidence that soluble fiber supplementation like Plantago psyllium decreases small dense LDL particles in association with lowered IL-6, reducing the risk of cardiovascular disease in obese adolescents.
Research Insights
There were no differences in HDL subclasses
- Effect
- Neutral
- Effect size
- Small
- Dose
- 10g/day for 7 weeks
IL-6 median 3.32 (1.24-5.96) vs 1.76 (0.54-3.28) pg/ml, p <0.0001
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 10g/day for 7 weeks
Post-treatment there was a decrease in sdLDL between the groups 2.0 (0-5.0) vs 1 (0-3.0) mg/dl (p = 0.004)
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 10g/day for 7 weeks
Adverse Events Reported
no adverse effects were reported in either group
- Finding
- Reported