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A clinical study to evaluate the glycemic index (glucose level in blood in 2 Hour period) and safety of COCOZEN in Human Volunteers.

An open label clinical study to evaluate the safety, tolerability and glycemic index of COCOZEN in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012389
Enrollment
20
Registered
2018-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: COCOZEN: 62.5g of COCOZEN (equivalent to 50g of glucose) one time during the glycemic index testing. Control Intervention1: Glucose: 50 g of Glucose - 3 times during the glycemic index

Sponsors

Akay Flavours and Aromatics Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Males and females in the age 18 â?? 55 years 2) Normal physical condition as determined by the investigator 3) Subject with body mass index 18.5- 27 Kg/m2 (Both inclusive) 4) Must be willing to comply with all study requirement 5) Subject should agree to avoid any kind of herbal formulations during the study period 6) Must be able and willing to provide a written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic and renal problems 2) Subjects who are currently under any kind of long term medication 3) Subjects with a known allergy to herbal products 4) Chronic drinkers 5) Subject with a habit of smoking 6) Subjects with abnormal biochemical or haematological values 7) Subjects with abnormal blood pressure 8) Pregnant or Lactating Women 9) Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.

Design outcomes

Primary

MeasureTime frame
Safety and tolerability assessment of COCOZEN by the measurement of hematological and Biochemical ParametersTimepoint: Day 0, Day 90

Secondary

MeasureTime frame
Glycemic index of COCOZENTimepoint: Day 0, Day 2, Day 4,Day 6

Countries

India

Contacts

Public ContactJestin V Thomas

Akay Flavours and Aromatics Private Limited

Krishnakumar.IM@akay-group.com04842686111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026