NCT03301675

Brief Summary

This study aimed to verify if combination of a healthy diet and orange juice consumption can minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

September 25, 2017

Last Update Submit

March 30, 2023

Conditions

Metabolic Syndrome

Keywords

Orange juiceHealthy dietMetabolic syndromeCardiometabolic risk factorsBody composition

Outcome Measures

Primary Outcomes (1)

  • LDL-C

    mg/dL

    12 weeks

Secondary Outcomes (20)

  • HDL-C

    12 weeks

  • Glucose

    12 weeks

  • Triglycerides

    12 weeks

  • Waist circunference

    12 weeks

  • Blood pressure systolic and diastolic

    12 weeks

  • +15 more secondary outcomes

Study Arms (2)

Orange juice

EXPERIMENTAL

Orange Juice: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) plus 100% orange juice (500 mL/d) during 12 weeks.

Other: Orange Juice (500 mL/d)

Control

NO INTERVENTION

Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks.

Interventions

Orange Juice (500 mL/d)OTHER

Nutritionists prescribed the same balanced diet for both groups keeping suffice energy to maintain the current weight, estimated from total energy expenditure (TEE) for each individual and based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ/ banana or other fruits and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were colected every two weeks; blood samples and dietary questionnaires, monthly.

Orange juice

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Three or more of the risk factors of MS: (1) waist circumference man ≥ 102 cm and woman ≥ 88 cm; (2) triglycerides ≥ 150 mg / dL; (3) HDL-C man ≤ 40 mg / dL and woman ≤ 50 mg / dL; (4) blood pressure ≥ 130 / ≥ 85 mm Hg and (5) fasting glucose ≥ 100 mg / dL (common diabetes, high blood pressure);
  • ≥ BMI ≤ 39.9 kg / m - overweight to grade II obesity;
  • Like to consume orange juice;

You may not qualify if:

  • Pregnant / nursing;
  • Use of vitamins or vitamin-food supplements in the last three months;
  • Individuals with diseases that require specific diet recommendations such as diabetes mellitus with insulin therapy and carbohydrate counts, cancer, chronic liver and kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Silveira JQ, Dourado GK, Cesar TB. Red-fleshed sweet orange juice improves the risk factors for metabolic syndrome. Int J Food Sci Nutr. 2015;66(7):830-6. doi: 10.3109/09637486.2015.1093610.

    PMID: 26471075BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thais B Cesar, Ph.D.

    Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 4, 2017

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 2, 2018

Last Updated

April 3, 2023

Record last verified: 2023-03