NCT03928249

Brief Summary

Supplementation with citrus bioflavonoids (hesperidin, naringin, diosmin and eriocitrin, among others) has been associated with an improvement in the glycidic and lipid profile, reduction of insulin resistance and systemic inflammation, and reduction of endothelial damage. This study aims to evaluate the effects of eriocitrin supplementation on the metabolic parameters of pre-diabetic individuals. Participants will be adults with pre-diabetes who will receive 200 mg / d of eriocitrin. Before, during and after treatment, anthropometric measures (weight, body composition and circumferences), biochemical (lipid and glucose profile, inflammatory parameters, endothelial markers, liver function, renal function) will be evaluated. Metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

April 17, 2019

Last Update Submit

October 22, 2020

Conditions

Pre Diabetes

Keywords

EriocitrinCitrus bioflavonoidsFlavanonePre-diabetesBlood glucose

Outcome Measures

Primary Outcomes (1)

  • Fasting glycemia

    Changes in serum glycemia concentration before and after administration of the intervention/placebo

    0-12-18-26 week

Secondary Outcomes (7)

  • Rate of change in plasma glucose concentration

    0-12-18-26 week

  • Rate of change in plasma HbA1c

    0-12-18-26 week

  • Rate of change in plasma insulin concentration

    0-12-18-26 week

  • Rate of change in plasma lipid concentration

    0-12-18-26 week

  • Rate of change in plasma hepatic enzymes

    0-12-18-26 week

  • +2 more secondary outcomes

Study Arms (2)

Grupo A

ACTIVE COMPARATOR

Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks

Dietary Supplement: Eriocitrin

GRUPO B

PLACEBO COMPARATOR

group B (n = 20) will receive 200 mg / d placebo for 12 weeks with washout for 2 weeks and then receive 200 mg / d placebo for 12 weeks

Dietary Supplement: Eriocitrin

Interventions

EriocitrinDIETARY_SUPPLEMENT

A crossover, double-blind, randomized, placebo-controlled clinical study with a duration of 26 weeks will be performed. All individuals and the principal investigator will remain blind to treatment until all analyzes are completed. Participants will be invited to attend 12-hour fasting to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview (Appendix B) to confirm eligibility according to the inclusion and exclusion criteria . The collection of blood and the glycemic curves will be performed at the beginning of the first, 12th, 14th and 26th week in the Laboratory of Clinical Analyzes ( Araraquara) At the beginning of the first, 12th, 14th and 26th week the following anthropometric parameters will be evaluated: body weight (kg), muscle mass (kg), fat mass (kg), body fat (%) (InBody 720, Biospace, Tokyo, Japan ) and waist-hip ratio.

GRUPO BGrupo A

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Increased fasting blood glucose from 6.1 to 7.0 mmol / L or,
  • Decreased glucose tolerance of 7 , 8 to 11.1 mmol / L or,
  • Glycated hemoglobin with values between 5.7 and 6.4%

You may not qualify if:

  • Use hypoglycemic, hypolipidemic drugs,
  • Use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds),
  • Exercise intensely (more than 10 hours per week)
  • History of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sao Paulo State University "Julio de Mesquita Filho"

Araraquara, São Paulo, 14800-903, Brazil

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

eriocitrin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thais B Cesar, Phd

    Sao Paulo State University "Julio de Mesquita Filho"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 26, 2019

Study Start

December 1, 2019

Primary Completion

June 15, 2020

Study Completion

October 22, 2020

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)