Prevention of inflammation in patients with diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This study investigates 4 weeks of daily supplementation with Astrobiome (3g stick) or a placebo (dextrin 3g stick) to take in the morning before breakfast by oral administration. Block randomization
Sponsors
INNOVATION LABO Sciences Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-smoker female and male subjects between 25 to 60 years (inclusive) of age with Type 2 diabetes (FPG ( = 126.0 mg/dl or 7.0mmol/L) for more than 6 months 2. Subjects with a BMI range of 25-35 kg/m2 (both inclusive) 3. Subjects using any medicines for diabetes must be stable on those medicines for a minimum of 3 months 4. Subject agreeing not to start any new anti-diabetic medicines or supplements during the course of the study 5. Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 6. Willing to give written informed consent and willing to comply with the trial protocol 7. Ability to understand the risks/benefits of the protocol 8. Subject should be available for the duration of the study period (1 month)
Exclusion criteria
Exclusion criteria: 1. Subjects suffering from gastrointestinal, CVD, renal, thyroid, liver or pancreatic diseases. 2. Subjects taking vitamins, prebiotics or probiotics. 3. Subjects having liver diseases. 4. Subjects on prolonged (Greater than 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, antipsychotic drugs, etc. or any other drugs that may have an influence on the outcome of the study. 5. Subjects with a history of alcohol or drug abuse 6. Pregnant/lactating woman 7. Subjects using other modulators like diet control, yoga, herbal supplements, etc and wish to continue after enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed at baseline and 4 weeks: 1. Fasting plasma insulin measured by radioimmunoassay 2. HbA1C measured using a latex agglutination immunoassay Homeostatic model assessment (HOMA) is calculated as Insulinemia *Glycemia/22.5= Insulin Resistance index | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline and 4 weeks: 1. IL-6 measured using enzyme-linked immunosorbent assay 2. TNF-a measured using enzyme-linked immunosorbent assay 3. Serum endotoxin level measured by immunoassay 4. Serum and Fecal Short Chain fatty acids measured using Gas Chromatography-Mass spectrometry (GC-MS) 5. Spontaneously reported and observed adverse events after the first dose until the end of the treatment visit | — |
Countries
Japan
Outcome results
None listed