Effects of 6-Month Probiotics and Calcium Supplementation During Childhood on Growth, Development, and Metabolic Parameters in Adolescents: A 10-Year Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Child's linear growth the age of 11-17 years
研究概览
简要总结
Stunting is still a major problem in developing countries, including Indonesia, and has been associated with impaired development. Stunted children have also a higher risk of metabolic syndrome in adulthood. The gut microbiota, as a part of intestinal integrity, may promote intake of nutrient during childhood. Probiotics supplementation may optimize the balance of gut microbiota and further improve child growth during the window period. Furthermore, calcium could also improve child growth by increasing the resistance to intestinal infection. However, the long-term effects of gut microbiota optimization during childhood using probiotics and calcium on growth, development, and the metabolic condition has not widely studied.
详细描述
This study was a 10-year follow-up study of randomized controlled trials of 6-month probiotics and calcium supplementation of Lactobacillus reuteri DSM 17938 or Lactobacillus casei CRL 431 in children aged 1-6 years (n=494) living in urban low socioeconomic communities of East Jakarta in 2007-2008. We re-enrolled the subjects to assess the long-term effects of probiotics and calcium supplementation on growth, development, and metabolic parameters at the age of 11-17 years.
Healthy children (n = 238) were included in this follow-up study. Each subject previously assigned to one intervention group: low-lactose milk with a low calcium content (LC = 53), a regular calcium content (RC = 70), regular calcium with L. reuteri DSM 17938 (n = 55), and regular calcium with L. casei CRL 431 (n = 60).
Anthropometric measurements were performed by measuring the weight and height of the subjects, and further combining the results to report BMI-for-age z-score. Height was also plotted to the chart of the World Health Organization (WHO) Child Growth Standards. Gut integrity was assessed with the lactulose-mannitol ratio using high-performance liquid chromatography (HPLC) method. Cognitive function, symptoms related to depression, behaviour, and serum brain-derived neurotrophic factors (BDNF) of the adolescents were evaluated used to investigate the effects of supplementation on development. We quantified lipid profile and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) as metabolic parameters using the vein blood sample. The metabolic parameters were measured in at least three groups of intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Child's linear growth the age of 11-17 years
时间窗: January - March 2019
Height-for-age z-score based on the WHO Child Growth Standards.
Child's height at the age of 11-17 years
时间窗: January - March 2019
Height in meters.
Child's weight at the age of 11-17 years
时间窗: January - March 2019
Weight in kilograms.
Child's nutritional status at the age of 11-17 years
时间窗: January - March 2019
BMI-for-age z-score based on the WHO Child Growth Standards. BMI was calculated from height and weight measurement.
次要结局
- Serum BDNF at the age of 11-17 years(January - March 2019)
- Gut integrity at the age of 11-17 years(January - March 2019)
- Cognitive function assessed using Raven's Progressive Matrices at the age of 11-17 years(January - March 2019)
- Symptoms related to depression assessed using Children Depression Inventory at the age of 11-17 years(January - March 2019)
- Behaviour assessed using Strength and Difficulties Questionnaire at the age of 11-17 years(January - March 2019)
- Triglyceride level at the age of 11-17 years(January - March 2019)
- Low-density lipoprotein level at the age of 11-17 years(January - March 2019)
- Fasting glucose level at the age of 11-17 years(January - March 2019)
- HOMA-IR at the age of 11-17 years(January - March 2019)
- High-density lipoprotein level at the age of 11-17 years(January - March 2019)
- Fasting insulin level at the age of 11-17 years(January - March 2019)
研究者
Rina Agustina
Principal Investigator
Indonesia University