Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.
- Conditions
- Childhood Obesity
- Interventions
- Drug: Docosahexaenoic Acid SupplementationOther: Promotion of physical activityOther: Promotion of healthy food habits
- Registration Number
- NCT04151758
- Lead Sponsor
- University of Milan
- Brief Summary
Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production.
- Detailed Description
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:
* Food intakes will be recorded by prospective 3-d weighed food records obtained with food scales. Parents will be advised on how to record all food and beverages consumed during 2 weekdays and 1 weekend day. Quantification and analysis of the energy intake and nutrient composition will be performed with an ad hoc PC software (MètaDieta®, Me.Te.Da S.r.l., San Benedetto del Tronto, Italy).
* Mediterranean Diet Quality Index (KIDMED) questionnaire for Mediterranean Diet assessment. The KIDMED index ranges from 0 to 12, and is based on a 16-question test that can be self-administered. The sums of the values from the administered test will be classified into three levels:
8 or more: optimal Mediterranean diet; 4-7: improvement needed to adjust intake to Mediterranean patterns. 3 or less: very low diet quality.
Hematological and biochemical status including:
Complete cell blood count;
Metabolic and nutritional parameters according to local routines for childhood obesity (fasting glucose, fasting insulin, LDL, HDL, total cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B levels, transaminases and amma-glutamyl transferase). Oral Glucose Tolerance Test (OGTT) will be performed. The insulin sensitivity and insulin resistance was assessed by calculating HOMA index (Homeostasis Model Assessment) and QUICKI (Quantitative Insulin-Sensitivity Check Index), using the following formulas:
HOMA: fasting plasma insulin in mU/l x FPG in mmol/l/22.5 QUICKI: 1/(log10 fasting plasma insulin in mU/l + log10 glucose in mg/dl)
Inflammatory index (VES, high-sensitive CRP, including fecal calprotectin)
Liver ultrasonography for detection of fatty liver disease
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docosahexaenoic Acid Supplementation, lifestyle intervention Docosahexaenoic Acid Supplementation Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged. Docosahexaenoic Acid Supplementation, lifestyle intervention Promotion of physical activity Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged. Docosahexaenoic Acid Supplementation, lifestyle intervention Promotion of healthy food habits Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged.
- Primary Outcome Measures
Name Time Method Changes in gut microbiota composition. 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 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
- Secondary Outcome Measures
Name Time Method Changes in fasting insulin levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in body mass index t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in waist circumference t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in triceps skinfold t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in total cholesterol levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in LDL cholesterol levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in HOMA index (Homeostasis Model Assessment) t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in fecal calprotectin levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in body mass composition t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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). body mass composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA)
Degree of fatty liver disease evaluated by echosonography of the liver t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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). body mass composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA)
Changes in HDL cholesterol levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in triglycerides levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in fasting glucose levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in QUICKI (Quantitative Insulin-Sensitivity Check Index) t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in alanine aminotransferase (ALT) levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in aspartate aminotransferase (ALT) levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in gamma glutamyl transferase (GGT) levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in systemic arterial blood pressure t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Complete cell blood count t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in C-reactive protein (CRP) levels t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Changes in erythrocyte sedimentation rate (ESR) t0: 0 t1: +4 months t2: +8 months Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile 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).
Oral glucose tolerance test (OGTT) result t0 Fasting glucose and glucose levels after 2 hours from ingestion of a glucose-containing solution.
Trial Locations
- Locations (1)
Ospedale San Paolo
🇮🇹Milan, Italy