Supplementation of juçara fruit pulp in the alterations in intestinal flora and inflammation in obese individuals

Phase 1

• Conditions: obesity, diabetes, dyslipidemia; C19.246.099; C18.452.584.500; C18.654.726.500

• Registration Number: RBR-5rxr2b
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Volunteers with obesity grade I and II (BMI between 30.0 and 39.9 kg / m2); Both genders; Age between 30 and 59 years

Exclusion Criteria

Eutrophic, low weight or with degree II obesity volunteers; Diagnoses of infectious diseases and / or severe chronic diseases; In use of anti-inflammatory and antibiotic drug; History of alcohol and drug abuse; pregnancy.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in the number of beneficial bacteria in feces and reduction of serum LPS in individuals supplemented with juçara, evaluated by the RT-PCR method and colorimetric test, based on the observation of a variation of at least 5% in the pre and post intervention measurements.

Secondary Outcome Measures

Name	Time	Method
Reduction of serum proinflammatory cytokines in subjects supplemented with juçara, evaluated by the ELISA method, based on the observation of a variation of at least 5% in the pre and post intervention measurements.<br>Reduction of body fat or fat free mass in individuals supplemented with juçara, evaluated by bioimpedance, from the observation of a variation of at least 5% in the pre and post intervention measurements.