Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.

NCT04151758 | Unknown Phase 4

• 1 other identifier: 2015/ST/135-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Childhood obesity; Gut microbiota; Nutrition; PUFA supplementation

Outcome Measures

Primary Outcomes (2)

• Changes in gut microbiota composition.

  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

  t0: 0 t1: +4 months t2: +8 months

• Changes in short-chain fatty acid production by gut microbiota

  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

  t0: 0 t1: +4 months t2: +8 months

Secondary Outcomes (22)

• 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 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

Study Arms (1)

Docosahexaenoic Acid Supplementation, lifestyle intervention

EXPERIMENTAL

Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged.

Drug: Docosahexaenoic Acid Supplementation; Other: Promotion of physical activity; Other: Promotion of healthy food habits

Interventions

Docosahexaenoic Acid Supplementation DRUG

Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day (2 ml per day DHA RICH OIL 25% aroma mandorla FoodAR Limbiate, Italy;50% DHA oil obtained from Schyzochitrium sp ; Martek Biosciences Corporation, Columbia, Maryland, USA) to all participants of the study. DHA 2 ml will provide about 16 kcal of energy.

Also known as: Lifestyle intervention, Diet intervention

Docosahexaenoic Acid Supplementation, lifestyle intervention

Promotion of physical activity OTHER

All participants will underwent a visit at t0, t1 and t2 in which physical activity will be promoted according to Italian dietary guidelines for childhood obesity.

Docosahexaenoic Acid Supplementation, lifestyle intervention

Promotion of healthy food habits OTHER

All participants will underwent a visit at t0, t1 and t2 in which healthy food habits will be promoted according to Italian dietary guidelines for childhood obesity.

Docosahexaenoic Acid Supplementation, lifestyle intervention

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<Age \<14 years
• Severe obesity (\>3 DS) according to WHO classification.
• Gestational age: 37-42 weeks.
• Birth-weight: \> 2500 g e \< 4000 g
• Caucasian

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Ospedale San Paolo

Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elvira Verduci

  Hospital San Paolo

  STUDY CHAIR

Central Study Contacts

Elvira Verduci, PhD

CONTACT

+39 3934771218; elvira.verduci@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: January 7, 2019
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)