Clinical trial on iCofeee product in healthy subjects

A randomized, multi-centre, double blind, placebo-controlled, three arm study to evaluate the safety and efficacy of iCoffee in maintaining or managing post-prandial blood glucose levels in healthy volunteers

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027806

Enrollment

Registered

2020-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Group Ãâ? Ã¢â?¬â?? iCoffee: Dose: 1 sachet twice a day 100-120 ml hot water Dosage : blend-based product Route of administration: Orally Duration:90 days Intervention2: Group II- Salc

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult males and non-pregnant females aged 18 to 55 years 2. Subjects who agree to stop from using supplements during the study period 3. Willing to give inform consent form 4. Subjects willing to follow the suggested diet plan. 5. Having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) and meeting one of the following criteria i. Fasting Plasma Glucose 100 to 125 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR ii. 2-h Post load Glucose 140 to 199 mg/dL during an OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.OR iii. Glycosylated hemoglobin (A1C) 5.7 to 6.4%. The test should be performed in a laboratory using a method that is NABL certified. 6. Subject with BMI Ã¢â?°Â¥ 25 kg/m2

Exclusion criteria

Exclusion criteria: 1. History of Type I or Type II Diabetes Mellitus 2. A know history or present condition of allergic response to any pharmaceutical products and supplements 3. Any history suggestive of micro vascular or macro vascular disease 4. Administration of any form of pharmacotherapy for the management of pre-diabetes in last 3 months. 5. Impaired renal function; eGFR 6. Known history of any chronic illness taking regular pharmacological agents. 7. Women in child bearing age unable to practice any form of contraception 8. Subjects who are pregnant or lactating 9. Subjects on herbal supplements/any other wellness product 10. History of alcohol, tobacco, substance or drug abuse 11. Subject who has participated in a clinical study within the last 30 days prior to entering this study. 12. Subject with hypersensitivity to any of the ingredients of the study products. 13. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

Design outcomes

Primary

Measure	Time frame
Laboratory Parameters Hematology, Biochemistry, liver profile, Kidney profile, Lipid Profile, Urine analysis, FBS, Body Weight & ECG at Screening (- 7-0 day) and end of the Study (90 day). Biomarkers: hsCRP and IL-6 levels at Baseline (0 day) and end of the Study (90 day). Timepoint: Day 0 and Day 90	—

Secondary

Measure	Time frame
1.Blood glucose levels (FBS &PPBS) 2.Glycosylated Haemoglobin (HbA1C) 3.2h-OGTT 4.Insulin Sensitivity Index 5.Serum Insulin 6.Mental Alertness measure with ZOGIM-A or other standardized questionnaire Timepoint: Day 0 Day 45 and Day 90	—

Countries

India

Contacts

Public ContactDr Balukolar

Radiant research services pvt. Ltd.

ashok@radiantresearch.in9880999297

Outcome results