Pre DiabetesNCT03928249
Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals
A study testing Eriocitrin in people with Pre Diabetes, run by São Paulo State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Eriocitrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2019to 22 Oct 2020
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 35-60 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%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Paulo State University "Julio de Mesquita Filho"
Araraquara, São Paulo, 14800-903
About this study
Official title: Therapeutic Intervention of Eriocitrin in Reducing Hyperglycemia in Pre-diabetic Subjects: Double-blind, Randomized, Placebo-controlled Crossover Clinical Trial
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.
Read the detailed description
Individuals aged 35-60 years and who present at least one of the following criteria: (1) increased fasting blood glucose from 6.1 to 7.0 mmol / L, (2) decreased glucose tolerance of 7 , 8 to 11.1 mmol / L, and (3) glycated hemoglobin with values between 5.7 and 6.4% 10 will be eligible to participate in this study. The exclusion criteria will be to use hypoglycemic, hypolipidemic drugs, 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.
The selected individuals will be distributed randomly in 2 groups through random number generator program. Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, with washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks; 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.
The primary endpoint will be fasting blood glucose, blood glucose 2 hours after oral glucose tolerance test (GTTO), and HbA1c. The secondary endpoint will be insulin, HOMA-IR, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, ALP, yGT, AST, ALT, TNF-α, IL-6, CRP, body weight, body mass index BMI), muscle mass, fat mass, body fat and waist-hip ratio, and macronutrient intake.
- Conditions
- Pre Diabetes
- Being tested
- Eriocitrin
- Keywords
- Eriocitrin, Citrus bioflavonoids, Flavanone, Pre-diabetes, Blood glucose
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Eriocitrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glycemia
Changes in serum glycemia concentration before and after administration of the intervention/placebo
Measured: 0-12-18-26 week
Secondary outcomes (7)
Rate of change in plasma glucose concentration
Changes in serum 2 hours after oral glucose tolerance test (mg/dL) before and after administration of the intervention / placebo
Measured: 0-12-18-26 week
Rate of change in plasma HbA1c
Changes in serum HbA1c (%) before and after administration of the intervention / placebo
Measured: 0-12-18-26 week
Rate of change in plasma insulin concentration
Changes in serum insulin (µU/mL) before and after administration of the intervention / placebo
Measured: 0-12-18-26 week
Rate of change in plasma lipid concentration
Changes in serum cholesterol (mg/dL), triglycerides (mg/dL),HDL-C(mg/dL), LDL-C(mg/dL) before and after administration of the intervention/placebo
Measured: 0-12-18-26 week
Rate of change in plasma hepatic enzymes
Changes in ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L) before and after administration of the intervention / placebo
Measured: 0-12-18-26 week
Rate of change in plasma inflammatory parameters
Changes in CRP (mg/dL), TNF-a (mg/dL), IL-6 (mg/dL) before and after administration of the intervention / placebo
Measured: 0-12-18-26 week
Rate of change in anthropometric parameters
Changes in body weight (Kg), muscle mass (Kg), fat mass (Kg) before and after administration of the intervention / placebo
Measured: 0-12-18-26 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Dec 2019
- Primary completion15 Jun 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cesar, São Paulo State University
- Investigators
- Thais B Cesar, Phd, Principal investigator, Sao Paulo State University "Julio de Mesquita Filho"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928249
- Sponsor's protocol ID
- SaoPSU12
- Status last verified
- Oct 2020
- First submitted
- 17 Apr 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Intervention of Eriocitrin in Reducing Hyperglycemia in Pre-diabetic Subjects: Double-blind, Randomized, Placebo-controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT03928249
- Acronym / sponsor ID
- SaoPSU12
- Conditions
- Pre Diabetes
- Keywords
- Eriocitrin, Citrus bioflavonoids, Flavanone, Pre-diabetes, Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals aged 35-60 years and who present at least one of the following criteria: (1) increased fasting blood glucose from 6.1 to 7.0 mmol / L, (2) decreased glucose tolerance of 7 , 8 to 11.1 mmol / L, and (3) glycated hemoglobin with values between 5.7 and 6.4% 10 will be eligible to participate in this study. The exclusion criteria will be to use hypoglycemic, hypolipidemic drugs, 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.
The selected individuals will be distributed randomly in 2 groups through random number generator program. Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, with washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks; 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.
The primary endpoint will be fasting blood glucose, blood glucose 2 hours after oral glucose tolerance test (GTTO), and HbA1c. The secondary endpoint will be insulin, HOMA-IR, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, ALP, yGT, AST, ALT, TNF-α, IL-6, CRP, body weight, body mass index BMI), muscle mass, fat mass, body fat and waist-hip ratio, and macronutrient intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grupo A | Active comparator | Dietary Supplement: EriocitrinGroup 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 |
| GRUPO B | Placebo comparator | Dietary Supplement: Eriocitringroup 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 |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 35-60 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%
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EriocitrinA 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. | Dietary supplement | GRUPO B, Grupo A |
Primary outcome
Fasting glycemia
Time frame: 0-12-18-26 week
Changes in serum glycemia concentration before and after administration of the intervention/placebo
7 secondary outcomes
Rate of change in plasma glucose concentration
Time frame: 0-12-18-26 week
Rate of change in plasma HbA1c
Time frame: 0-12-18-26 week
Rate of change in plasma insulin concentration
Time frame: 0-12-18-26 week
Rate of change in plasma lipid concentration
Time frame: 0-12-18-26 week
Rate of change in plasma hepatic enzymes
Time frame: 0-12-18-26 week
Rate of change in plasma inflammatory parameters
Time frame: 0-12-18-26 week
Rate of change in anthropometric parameters
Time frame: 0-12-18-26 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais B Cesar, Phd principal investigator
Sao Paulo State University "Julio de Mesquita Filho"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eriocitrin in people with Pre Diabetes, run by São Paulo State University 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 4 inclusion and 4 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 23 Oct 2020. 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?
Fasting glycemia (time frame: 0-12-18-26 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2020.