- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925909
Supplementation of Eriocitrin in Intestinal Microbiota
Effect of Chronic Eriocitrin Supplementation on the Intestinal Microbiota of Pre-diabetic and Insulin Resistant Individuals
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
Araraquara, SP, Brazil, 14800-903
- Sao Paulo State University "Julio de Mesquita Filho"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eriomin 200 mg
The volunteers will receive one capsule containing 200 mg eriocitrin
|
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.
|
Experimental: Eriomin 400 mg
The volunteers will receive one capsule containing 400 mg eriocitrin
|
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.
|
Experimental: Eriomin 800 mg
The volunteers will receive one capsule containing 800 mg eriocitrin
|
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.
|
No Intervention: Placebo
The volunteers will receive a capsule containing corn starch (placebo)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change in microbiome
Time Frame: 0-12 week
|
Changes in microbiome before and after administration of the intervention / placebo
|
0-12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change in plasma glucose concentration
Time Frame: 0-12 week
|
Changes in serum 2 hours after oral glucose tolerance test, HbA1c, insulin, HOMA-IR before and after administration of the intervention / placebo
|
0-12 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thais B Cesar, Phd, ao Paulo State University "Julio de Mesquita Filho"
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SaoPSU 13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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