A clinical study of nutritional and phytoconstituents supplementation in prediabetic subjects

Not Applicable

Not yet recruiting

• Conditions: Health Condition 1: R739- Hyperglycemia, unspecified

• Registration Number: CTRI/2022/12/047809
• Lead Sponsor: Meyer Organics Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female subjects of 30 to 60 years of age (both inclusive)

2. BMI >=28.00-<=35 kg/m2 at screening. (Overweight to obese)

3. Hemoglobin A1c (HbA1c) >=5.7 % and <=6.4%.

4. Fasting Plasma Glucose (FPG) between 100-125 mg/Dl both inclusive.

Exclusion Criteria

1. Subjects with type 1 or type 2 diabetes mellitus (T2DM), gestational diabetes (GDM), or secondary diabetes;

2. Treatment with glucose lowering agent (s) within 90 days before screening.

3. Subjects with elevated liver enzymes AST and/or ALT >3 times of the upper normal limit

4. Subjects with abnormal renal function as measured by eGFR <45ml/min/1.73m2

5. Subjects with BMI more than 35Kg/m2

6. Subjects who had a bariatric surgery.

7. Pregnant or lactating women.

8. Smokers/Alcoholics and/or drug abusers.

9. Subjects with known history or ongoing malignancy.

10. Treatment with immunosuppressive medications in past three months.

11. Subjects suffering from major systemic illness necessitating medical care.

12. Any other reason which can affect the participation of the subject in the study as per investigatorâ??s discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. HbA1c, fasting and post meal plasma glucose levels from screening to end of the study. <br/ ><br>2. HOMA-IR score (calculated insulin resistance based on formula with fasting plasma glucose and fasting serum insulin levels) at screening and end of the study.Timepoint: Screening to end of the study

Secondary Outcome Measures

Name	Time	Method
1. Anthropometric parameters like body weight, BMI and % body fat by impendence test at screening and end of the study. <br/ ><br>2. Changes in lipid profile at screening and end of the study. <br/ ><br>3. Changes in perceived stress score at screening and end of the study. <br/ ><br>4. Changes in HRQOL-15D questionnaire score to assess quality of life at screening and end of the study.Timepoint: Screening to end of the study