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Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.

NCT04151758 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-03

No results posted yet for this study

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

Interventions

DRUG

Docosahexaenoic Acid Supplementation

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.

OTHER

Promotion of physical activity

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.

OTHER

Promotion of healthy food habits

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.

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Elvira Verduci · Hospital San Paolo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151758 on ClinicalTrials.gov