Clinical trial NCT04151758: Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.
Official title: Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn. The DAMOCLE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Childhood Obesity
Keywords: Childhood obesity
Gut microbiota
Nutrition
PUFA supplementation
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Changes in gut microbiota composition.
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in short-chain fatty acid production by gut microbiota
timeFrame: t0: 0 t1: +4 months t2: +8 months
Secondary outcomes:
measure: Changes in total cholesterol levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in LDL cholesterol levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in HDL cholesterol levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in triglycerides levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in fasting glucose levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in fasting insulin levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in HOMA index (Homeostasis Model Assessment)
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in QUICKI (Quantitative Insulin-Sensitivity Check Index)
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in alanine aminotransferase (ALT) levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in aspartate aminotransferase (ALT) levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in gamma glutamyl transferase (GGT) levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in body mass index
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in waist circumference
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in triceps skinfold
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in systemic arterial blood pressure
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Complete cell blood count
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in C-reactive protein (CRP) levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in erythrocyte sedimentation rate (ESR)
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in fecal calprotectin levels
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Changes in body mass composition
timeFrame: t0: 0 t1: +4 months t2: +8 months
measure: Oral glucose tolerance test (OGTT) result
timeFrame: t0
measure: Degree of fatty liver disease evaluated by echosonography of the liver
timeFrame: t0: 0 t1: +4 months t2: +8 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Paolo
Study officials:
affiliation: Hospital San Paolo
name: Elvira Verduci
role: STUDY_CHAIR
References: