Pre DiabetesNCT03925909
Supplementation of Eriocitrin in Intestinal Microbiota
A study testing Eriocitrin in people with Pre Diabetes, run by São Paulo State University at 1 site in Brazil.
Trial summary
Pre-diabetes is characterized by high plasma concentration of glucose and glycated hemoglobin and is the main risk factor for the development of type 2 diabetes. Several studies show that the intestinal microbiota is intimately linked to cardio-metabolic factors (type 2 diabetes, insulin resistance) when in situations… Read more about this study
- Who is it for?
- Ages 30 to 60 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?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2019to 23 Mar 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30-60 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: Effect of Chronic Eriocitrin Supplementation on the Intestinal Microbiota of Pre-diabetic and Insulin Resistant Individuals
Pre-diabetes is characterized by high plasma concentration of glucose and glycated hemoglobin and is the main risk factor for the development of type 2 diabetes. Several studies show that the intestinal microbiota is intimately linked to cardio-metabolic factors (type 2 diabetes, insulin resistance) when in situations of dysbiosis. Food is a key element for a healthy microbiota, focusing on the consumption of polyphenols that modulate the intestinal environment through its alteration and production of short chain fatty acids, and can thus be a way of reversing situations such as pre- diabetes and insulin resistance. The objective of the study will be to investigate whether chronic supplementation of eriocitrin alters the intestinal microbiota of pre-diabetic and insulin resistant individuals, reversing these situations. This will be done by supplementation of eriocitrin-containing capsules with different dosages in pre-diabetic and insulin resistant individuals. There will be 12 weeks of intervention, with faecal collections, anthropometric and dietary evaluation, and then will be made microbiological analysis to identify the intestinal microbiota and biochemical analysis before and after the intervention. For statistical analysis, normality and homogeneity test (Kolmogorov-Smirnov and Levine test respectively), T-test to compare baseline time between groups and repeated-measures ANOVA (two-way) were used to compare changes within and between groups.
Read the detailed description
Individuals of both sexes between 30 and 60 years of age who present fasting glycemia between 100 mg / dL (5,6 mmol / L) and 125 mg / dL (6,9 mmol / L) 50, or concentration of glycated hemoglobin between 5.7% (39 mmol / mole) and 6.4% (47 mmol / mole) 50, or glycemic concentrations in the oral glucose tolerance test between 140mg / dL (7.8 mmol / L) to 199mg / dL (11.0 mmol / L) 50. The study will also include insulin-resistant individuals: insulin above 25 uU / mL, or who present HOMA-IR score above 2.7.
Individuals using supplements (vitamins, bioflavonoids), pregnant women and those who practice intense physical exercise (> 10h / week) will be excluded from the study.
The primary endpoint will be alteration of the microbiota with possible improvement of the glycemic profile, leading to the reversal of pre-diabetes and insulin resistance.
- Conditions
- Pre Diabetes
- Being tested
- Eriocitrin
- Keywords
- Eriocitrin, Citrus bioflavonoids, Flavanone, Pre-diabetes, Blood glucose, Microbiome
- 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 responsible nutritionists will do 1) Anthropometric Assessment, in which weight data will be collected (kg); height (m); waist circumference (cm), waist circumference (cm) and hip circumference (cm), muscle mass (kg /%) and percentage of fat by means of bioimpedance equipment; 2) Dietary assessment, which will be performed through a 24-hour Food Recall, a 3-day Food Record and a Food Consumption Frequency Questionnaire; 3) Evaluation of the microbiota, for which stool will be collected from the last 24 hours on the day before the beginning of the experiment and at the end of the study (week 12); 3) Biochemical evaluation, which includes the collection of 30 mL of blood to be performed by trained and qualified technicians.
| Study group | Role | What they receive |
|---|---|---|
| Eriomin 200 mg | Experimental | The volunteers will receive one capsule containing 200 mg eriocitrin Receives: Dietary Supplement: Eriocitrin |
| Eriomin 400 mg | Experimental | The volunteers will receive one capsule containing 400 mg eriocitrin Receives: Dietary Supplement: Eriocitrin |
| Eriomin 800 mg | Experimental | The volunteers will receive one capsule containing 800 mg eriocitrin Receives: Dietary Supplement: Eriocitrin |
| Placebo | No intervention | The volunteers will receive a capsule containing corn starch (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in microbiome
Changes in microbiome before and after administration of the intervention / placebo
Measured: 0-12 week
Secondary outcomes (1)
Rate of change in plasma glucose concentration
Changes in serum 2 hours after oral glucose tolerance test, HbA1c, insulin, HOMA-IR before and after administration of the intervention / placebo
Measured: 0-12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 May 2019
- Primary completion1 Aug 2019
- Study completion23 Mar 2020
Why it stopped: Because there was no funding
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
- Parallel groups
- 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, ao Paulo State University "Julio de Mesquita Filho"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925909
- Sponsor's protocol ID
- SaoPSU 13
- Status last verified
- Mar 2020
- First submitted
- 17 Apr 2019
- Last updated
- 25 Mar 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 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Eriocitrin Supplementation on the Intestinal Microbiota of Pre-diabetic and Insulin Resistant Individuals
- ClinicalTrials.gov ID
- NCT03925909
- Acronym / sponsor ID
- SaoPSU 13
- Conditions
- Pre Diabetes
- Keywords
- Eriocitrin, Citrus bioflavonoids, Flavanone, Pre-diabetes, Blood glucose, Microbiome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because there was no funding
- Enrolment
- 40 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 24 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.
Pre-diabetes is characterized by high plasma concentration of glucose and glycated hemoglobin and is the main risk factor for the development of type 2 diabetes. Several studies show that the intestinal microbiota is intimately linked to cardio-metabolic factors (type 2 diabetes, insulin resistance) when in situations of dysbiosis. Food is a key element for a healthy microbiota, focusing on the consumption of polyphenols that modulate the intestinal environment through its alteration and production of short chain fatty acids, and can thus be a way of reversing situations such as pre- diabetes and insulin resistance. The objective of the study will be to investigate whether chronic supplementation of eriocitrin alters the intestinal microbiota of pre-diabetic and insulin resistant individuals, reversing these situations. This will be done by supplementation of eriocitrin-containing capsules with different dosages in pre-diabetic and insulin resistant individuals. There will be 12 weeks of intervention, with faecal collections, anthropometric and dietary evaluation, and then will be made microbiological analysis to identify the intestinal microbiota and biochemical analysis before and after the intervention. For statistical analysis, normality and homogeneity test (Kolmogorov-Smirnov and Levine test respectively), T-test to compare baseline time between groups and repeated-measures ANOVA (two-way) were used to compare changes within and between groups.
Detailed description
Individuals of both sexes between 30 and 60 years of age who present fasting glycemia between 100 mg / dL (5,6 mmol / L) and 125 mg / dL (6,9 mmol / L) 50, or concentration of glycated hemoglobin between 5.7% (39 mmol / mole) and 6.4% (47 mmol / mole) 50, or glycemic concentrations in the oral glucose tolerance test between 140mg / dL (7.8 mmol / L) to 199mg / dL (11.0 mmol / L) 50. The study will also include insulin-resistant individuals: insulin above 25 uU / mL, or who present HOMA-IR score above 2.7.
Individuals using supplements (vitamins, bioflavonoids), pregnant women and those who practice intense physical exercise (> 10h / week) will be excluded from the study.
The primary endpoint will be alteration of the microbiota with possible improvement of the glycemic profile, leading to the reversal of pre-diabetes and insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eriomin 200 mg | Experimental | Dietary Supplement: EriocitrinThe volunteers will receive one capsule containing 200 mg eriocitrin |
| Eriomin 400 mg | Experimental | Dietary Supplement: EriocitrinThe volunteers will receive one capsule containing 400 mg eriocitrin |
| Eriomin 800 mg | Experimental | Dietary Supplement: EriocitrinThe volunteers will receive one capsule containing 800 mg eriocitrin |
| Placebo | No intervention | –The volunteers will receive a capsule containing corn starch (placebo) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 30-60 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 |
|---|---|---|
| EriocitrinThe responsible nutritionists will do 1) Anthropometric Assessment, in which weight data will be collected (kg); height (m); waist circumference (cm), waist circumference (cm) and hip circumference (cm), muscle mass (kg /%) and percentage of fat by means of bioimpedance equipment; 2) Dietary assessment, which will be performed through a 24-hour Food Recall, a 3-day Food Record and a Food Consumption Frequency Questionnaire; 3) Evaluation of the microbiota, for which stool will be collected from the last 24 hours on the day before the beginning of the experiment and at the end of the study (week 12); 3) Biochemical evaluation, which includes the collection of 30 mL of blood to be performed by trained and qualified technicians. | Dietary supplement | Eriomin 200 mg, Eriomin 400 mg, Eriomin 800 mg |
Primary outcome
Rate of change in microbiome
Time frame: 0-12 week
Changes in microbiome before and after administration of the intervention / placebo
1 secondary outcome
Rate of change in plasma glucose concentration
Time frame: 0-12 week
Results and safety
The study was stopped early (reason given: Because there was no funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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
ao 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: stopped early, as of the sponsor's last update on 25 Mar 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. 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 was stopped early (reason given: Because there was no funding). Results are not available in the source record.
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?
Rate of change in microbiome (time frame: 0-12 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 25 Mar 2020.