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Pre DiabetesNCT03215043

Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

A study testing Eriocitrin in people with Pre Diabetes, run by Thais Cesar at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 59 years
Conditions the study is for
Pre Diabetes
What is being tested?
Eriocitrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteBrazil
Study dates
2 Jul 2017to 28 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    Araraquara, São Paulo, 14800-903

Other trials in Brazil

About this study

Official title: Evaluation of Metabolic Parameters in Subjects With Intermediate Hyperglycemia Supplemented With Eriocitrin: A Parallel, Double-blind, Randomized, Placebo-controlled Clinical Trial

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

Read the detailed description

Volunteers will be invited to appear in a 12-hour fast to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview to confirm eligibility according to the inclusion and exclusion criteria. The collection of blood and the glycemic curves will be carried out next to a Laboratory of Clinical Analyzes, commercial, based in the city of Araraquara.

The sample number took into account variances on glycated hemoglobin with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Mohammad, 2015). The minimum sample size considering an approximately 20% dropout rate, should have 20 individuals per group.

In order to ensure adequate nutrition for the nutritional and energetic needs of volunteers, an individual food plan shall be prescribed, calculated according to the DRI equations. The volunteer will be asked to complete the Food Record for three days at the 3rd, 5th, 7th, 9th and 11th week. Data analysis of energy intake, macronutrients and micronutrients will be performed through the DietBox® . The anthropometric measurements will be performed before the intervention and in the 3rd, 5th, 7th, 9th and 11th week by Nutritionist. Four samples of 30mL of fasting blood each will be obtained before the intervention, in the 4th, 8th and 12th week in the Laboratory of Clinical Analyzes. The blood will be centrifuged to obtain the serum, which will be frozen at -80 ° C until subsequent biochemical analyzes.

Normality and homogeneity will be evaluated by Shapiro-Wilk test and Levine tests, respectively. The T test will be used to compare baseline time between groups. The two-way repeated-measures ANOVA will be used to compare changes within and between the eriocitrin and control groups over the 12-week period. P significant at ≤ 0.05.

Conditions
Pre Diabetes
Being tested
Eriocitrin, Placebo
Keywords
Eriocitrin, Intermediate hyperglycemia, Citrus bioflavonoids
Medical subject headings
Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT03215043
Study groupRoleWhat they receive
Group AExperimentalIndividuals will receive a dose of 140 mg / d eriocitrin for 12 weeks
Receives: Dietary Supplement: Eriocitrin
Group BExperimentalIndividuals will receive a dose of 280 mg / d eriocitrin for 12 weeks
Receives: Dietary Supplement: Eriocitrin
Group CExperimentalIndividuals will receive a dose of 560 mg / d eriocitrin for 12 weeks
Receives: Dietary Supplement: Eriocitrin
Group DPlacebo comparatorIndividuals will receive the placebo with corn starch excipient for 12 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose

    mg/dL

    Measured: 12 Weeks

Secondary outcomes (13)

  1. glycated hemoglobin

    percentage

    Measured: 12 Weeks

  2. insulin

    µU/mL

    Measured: 12 Weeks

  3. Cholesterol

    mg/dL

    Measured: 12 Weeks

  4. triglycerides

    mg/dL

    Measured: 12 Weeks

  5. HDL-C

    mg/dL

    Measured: 12 Weeks

  6. LDL-C

    mg/dL

    Measured: 12 Weeks

  7. TNF-alpha

    pg.mL

    Measured: 12 Weeks

  8. Interleucina 6

    pg.mL

    Measured: 12 Weeks

  9. c-reactive protein

    mg/dL

    Measured: 12 Weeks

  10. aspartate aminotransferase

    U/L

    Measured: 12 Weeks

  11. alkaline phosphatase

    U/L

    Measured: 12 Weeks

  12. Gamma-Glutamyl Transferase

    U/L

    Measured: 12 Weeks

  13. alanine aminotransferase

    U/L

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study start2 Jul 2017
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03215043
Sponsor's protocol ID
SaoPSU7
Status last verified
Aug 2023
First submitted
11 Jul 2017
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Eriocitrin in people with Pre Diabetes, run by Thais Cesar at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215043, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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