NCT03215043

Brief Summary

First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be evaluated. It is expected that 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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 2, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

July 11, 2017

Last Update Submit

August 29, 2023

Conditions

Pre Diabetes

Keywords

EriocitrinIntermediate hyperglycemiaCitrus bioflavonoids

Outcome Measures

Primary Outcomes (1)

  • Glucose

    mg/dL

    12 Weeks

Secondary Outcomes (13)

  • glycated hemoglobin

    12 Weeks

  • insulin

    12 Weeks

  • Cholesterol

    12 Weeks

  • triglycerides

    12 Weeks

  • HDL-C

    12 Weeks

  • +8 more secondary outcomes

Other Outcomes (4)

  • Body mass

    12 Weeks

  • fat mass

    12 Weeks

  • percentage of total body fat

    12 Weeks

  • +1 more other outcomes

Study Arms (4)

Group A

EXPERIMENTAL

Individuals will receive a dose of 140 mg / d eriocitrin for 12 weeks

Dietary Supplement: Eriocitrin

Group B

EXPERIMENTAL

Individuals will receive a dose of 280 mg / d eriocitrin for 12 weeks

Dietary Supplement: Eriocitrin

Group C

EXPERIMENTAL

Individuals will receive a dose of 560 mg / d eriocitrin for 12 weeks

Dietary Supplement: Eriocitrin

Group D

PLACEBO COMPARATOR

Individuals will receive the placebo with corn starch excipient for 12 weeks

Other: Placebo

Interventions

EriocitrinDIETARY_SUPPLEMENT

The selected individuals will be randomly distributed in 4 groups through random number generator program. Group A (n = 20) will receive a dose of 140 mg / d eriocitrin; Group B (n = 20) eriocitrin 280 mg / d; The C group (n = 20) 560 mg / d eriocitrin; And group D (n = 20) will receive the placebo with corn starch excipient. All doses will be packaged in Manipulation Pharmacy, and should be of the same type, color and size. Individuals will be instructed to regularly ingest a pre-dinner capsule for 12 weeks.

Group AGroup BGroup C
PlaceboOTHER

The selected individuals will be randomly distributed in 4 groups through random number generator program. Group A (n = 20) will receive a dose of 140 mg / d eriocitrin; Group B (n = 20) eriocitrin 280 mg / d; The C group (n = 20) 560 mg / d eriocitrin; And group D (n = 20) will receive the placebo with corn starch excipient. All doses will be packaged in Manipulation Pharmacy, and should be of the same type, color and size. Individuals will be instructed to regularly ingest a pre-dinner capsule for 12 weeks.

Group D

Eligibility Criteria

Age30 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Glycemia of 6.1 to 7.0 mmol / L
  • Glycated hemoglobin with values between 5.7 and 6.4%

You may not qualify if:

  • use of drugs, vitamins and dietary supplements, alcohol consumption (\> 20 g alcohol/d), and intense physical activity (\> 5 hours/week).
  • History of cardiovascular disease, diabetes mellitus, liver or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Araraquara, São Paulo, 14800-903, Brazil

Location

Related Publications (1)

  • Mohammad M, et al. Effects of Hesperidin Supplementation on Glycemic Control, Lipid Profile and Inflammatory Markers in Patients with Type 2 Diabetes: A Randomized Double Blind Placebo Control Clinical Trial. Research Article, Acta Biologica Indica 2015, 4(1):75-83. ISSN 2279-0160

    BACKGROUND

Related Links

MeSH Terms

Conditions

Glucose Intolerance

Interventions

eriocitrin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose 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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 12, 2017

Study Start

July 2, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

BR(1)