Clinical Trial to investigate the Safety and Efficacy of the BugSpeaks based personalized diet on the patients with Hyperglycemia and Hyperlipidemia.
- Conditions
- Health Condition 1: Z724- Inappropriate diet and eating habits
- Registration Number
- CTRI/2022/05/042791
- Lead Sponsor
- eucine Rich Bio Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Men and women from 45 to 65 years.
2. Body Mass Index (BMI) >= 19 and < 40 kg/m2
3. Signed informed consent.
4. Free of infections at baseline
5. HbA1c more than or equal to 7% - 10% or LDL cholesterol more than or equal to 120 mg/dL.
6. Patient who agrees to follow personalized diet for 3 months.
7. Subject on stable dose of oral Hypoglycemic medication except Metformin for the past 3 months or lifestyle intervention.
8. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on stable dose for at least three months prior to screening visit. These medications will not be changed during intervention unless it is mandatory.
Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1. Individuals with severe diseases (hepatic, kidney, cancerâ?¦).
2. Individuals with Chronic Intestinal Pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohns Disease).
3. Individuals with dementia, mental disease or low cognitive function.
4. Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or
immunosuppressants.
5. Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months.
6. Individuals treated with oral antibiotics during two weeks prior to the beginning of the study.
7. Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study.
8. Women that consume oral contraceptive.
9. Pregnant women or breastfeeding.
10. Individuals with intensive physical activity ( > 2 hours, more than 3 times per week).
11. Individuals that consume antioxidant supplement, drugs, Ï?-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study.
12. Individuals with regular consumption ( > 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheeseâ?¦) and/or use of other prebiotics and not to accept suppress their consumption during the study.
13. Individuals with increased alcohol consumption >30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey, brandy, anise, etc.)
14. Individuals with regular use of laxatives ( > 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.
15. Patients who have received tumor immunotherapy (such as PD-1/L1, CTLA4, etc.) in the past 1 month, and inflammatory factor modulators such as Ulinastatin.
16. Patients who have received organ transplantation or surgery planning in the past 6 months.
17. Patients who cannot take food or drugs due to coma or intestinal obstruction.
18. Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
19. Women subjects that are pregnant or lactating, or subjects (including male subjects) having a
pregnancy plan (including plans for sperm donation or egg donation) during the study period.
20. Patients who have participated in any other clinical study within 2 weeks prior to randomization.
21. The investigators conclude that the patient is not suitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients showing clinical improvement in HbA1c levels. <br/ ><br>2. Proportion of patients showing clinical improvement In Lipid Profile. <br/ ><br>3. Improvement in Overall Gut Microbiota. <br/ ><br>4.Proportion of Patients showing improvement in CRP. <br/ ><br>5. Change from baseline interleukin 10 (IL10)Timepoint: Time Frame for all: 0 and 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) <br/ ><br>2.Change from baseline natural killer cells cytotoxicity potential.Timepoint: 1. Time Frame: <br/ ><br>Throughout the study <br/ ><br>2. Time Frame: 0 and 12 weeks