Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn. The DAMOCLE Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in gut microbiota composition.
研究概览
简要总结
Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production.
详细描述
Differences in gut microbiota composition and function will be evaluated in obese children before starting the DHA supplementation and dietary-lifestyle intervention, at the end of DHA supplementation (4 months) e after 4 months of dietary dietary-lifestyle intervention without DHA supplementation. The investigators will identify the role of DHA on the intestinal microbiota and indicative species related to insulin resistance (IR). The investigators will determine whether DHA supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities.
The following tasks will be also performed at t0, t1 and t2:
Clinical examination including: physical examination, Tanner score evaluation; Bristol Stool Chart Blood pressure will be checked in all children by using oscillometric devices validated in the pediatric age group.
Anthropometry including body circumferences and skinfolds, calculation of BMI z scores and body composition. Body composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA).
Dietary assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 <Age <14 years
- •Severe obesity (>3 DS) according to WHO classification.
- •Gestational age: 37-42 weeks.
- •Birth-weight: > 2500 g e < 4000 g
- •Caucasian
排除标准
- •secondary obesity
- •supplementation with pre/probiotics (in the previous 3 months);
- •antibiotic treatment (in the previous 3 months);
- •chronic or acute intestinal diseases (in the previous 3 months).
研究组 & 干预措施
Docosahexaenoic Acid Supplementation, lifestyle intervention
Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged.
干预措施: Docosahexaenoic Acid Supplementation (Drug)
Docosahexaenoic Acid Supplementation, lifestyle intervention
Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged.
干预措施: Promotion of physical activity (Other)
Docosahexaenoic Acid Supplementation, lifestyle intervention
Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged.
干预措施: Promotion of healthy food habits (Other)
结局指标
主要结局
Changes in gut microbiota composition.
时间窗: t0: 0 t1: +4 months t2: +8 months
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Study of the microbiota biodiversity will be performed by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children
Changes in short-chain fatty acid production by gut microbiota
时间窗: t0: 0 t1: +4 months t2: +8 months
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) will be performed in order to monitor the effect of postbiotics intake modulating microbial metabolite production
次要结局
- Changes in fasting insulin levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in body mass index(t0: 0 t1: +4 months t2: +8 months)
- Changes in waist circumference(t0: 0 t1: +4 months t2: +8 months)
- Changes in total cholesterol levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in LDL cholesterol levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in HOMA index (Homeostasis Model Assessment)(t0: 0 t1: +4 months t2: +8 months)
- Changes in triceps skinfold(t0: 0 t1: +4 months t2: +8 months)
- Changes in fecal calprotectin levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in body mass composition(t0: 0 t1: +4 months t2: +8 months)
- Degree of fatty liver disease evaluated by echosonography of the liver(t0: 0 t1: +4 months t2: +8 months)
- Changes in HDL cholesterol levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in triglycerides levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in fasting glucose levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in QUICKI (Quantitative Insulin-Sensitivity Check Index)(t0: 0 t1: +4 months t2: +8 months)
- Changes in alanine aminotransferase (ALT) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in aspartate aminotransferase (ALT) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in gamma glutamyl transferase (GGT) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in systemic arterial blood pressure(t0: 0 t1: +4 months t2: +8 months)
- Complete cell blood count(t0: 0 t1: +4 months t2: +8 months)
- Changes in C-reactive protein (CRP) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in erythrocyte sedimentation rate (ESR)(t0: 0 t1: +4 months t2: +8 months)
- Oral glucose tolerance test (OGTT) result(t0)