Effect of blood orange juice intake on inflammatory response in overweight women.

Chronic effect of blood orange juice intake on microRNA expression profile and inflammatory response in overweight women.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-3p4ddh5

Enrollment

Unknown

Registered

2021-03-04

Start date

2017-08-18

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Interventions

Experimental group: 20 overweight women received 500 mL of blood orange juice per day for 4 weeks. There was no control group. The intervention started after the first data collection (anthropometric,

G07.203.650.283

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: women between 18 and 40 years old; BMI between twenty-five and twenty-nine and nine kg/m² and be willing to adhere to the study protocol and to sign the informed consent form.

Exclusion criteria

Exclusion criteria: men; under 18 years old or over 40 years old; BMI less than twenty-five kg/m² or greater than twenty-nine and nine kg/m²; be an athlete; diagnosis of diabetes mellitus; use medication to control inflammation, plasma lipid profile (statins, fibrates (fenofibrate), Omacor, etc.) or systemic blood pressure (ACE inhibitors, angiotensin 2 receptor blockers, calcium channel blockers, ?-inhibitors and diuretics); make use of vitamin supplements, probiotics, prebiotics, symbiotics, antibiotics or any other medicine that may interfere with the intestinal microbiota; have a habit of frequently consuming grape juice; having had alcohol in the 7 days prior to the study; be a smoker; have any chronic gastrointestinal disease (eg inflammatory bowel disease, celiac disease, cancer); being pregnant and / or participating in another study.

Design outcomes

Primary

Measure	Time frame
Primary endpoint 1: Check modulation of microRNA expression related with inflammation by real-time PCR, being expected 95% of problaby confiance probability test.;Primary endpoint 2: Check modulation of the concentration of inflammation-related biomarkers by ELISA method, being expected 95% of problaby confiance probability test.;Primary endpoint 3: Check modulation of intestinal microbiota and metabolism.	—

Measure

Time frame

Primary endpoint 1: Check modulation of microRNA expression related with inflammation by real-time PCR, being expected 95% of problaby confiance probability test.;Primary endpoint 2: Check modulation of the concentration of inflammation-related biomarkers by ELISA method, being expected 95% of problaby confiance probability test.;Primary endpoint 3: Check modulation of intestinal microbiota and metabolism.

—

Secondary

Measure	Time frame
Secondary endpoint 1: Check a improvement of lipid profile by colorimetric analysis, being expected 95% of problaby confiance probability test.;Secondary endpoint 2: Check a improvement of blood glucose by colorimetric test, being expected 95% of problaby confiance probability test.	—

Countries

Brazil

Contacts

Public ContactMarcelo Rogero

Faculdade de Saúde Pública da Universidade de São Paulo

mmrogero@usp.br+55-11-30617850

Outcome results

None listed

Source: REBEC (via WHO ICTRP)