KurCoSmart Effects on People With Type 2 DM

Sponsor

Universitas Sebelas Maret (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05407467

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Insulin Resistance Inflammation Body Weight	Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)	Phase 1/Phase 2

Detailed Description

The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group There is no additional intervention other than subject's standard diabetes treatment
Experimental: Interventional Group This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment	Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart) we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result

Arm

Intervention/Treatment

No Intervention: Control Group

There is no additional intervention other than subject's standard diabetes treatment

Experimental: Interventional Group

This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment

Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)

we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result

Outcome Measures

Primary Outcome Measures

Blood glucose [Change of Blood glucose at 1 months]
Subject's fasting and prandial blood glucose
Inflammation degree [Change of hs-CRP at 1 Months]
Subject's high sensitivity C-reactive protein level
insulin resistance [Change of HOMA IR at 1 Months]
Subject's HOMA IR
HbA1c [Change of HbA1C at 1 Months]
Subject's glycated haemoglobin level

Secondary Outcome Measures

Body Mass Index [Change of BMI at 1 Months]
Subject's height and body weight
Blood Pressure [Change fof blood prssure at 1 Months]
Subject's blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed Type 2 DM
Signing consent form

Exclusion Criteria:

Pregnant or breastfeeding
Multiple organ failure
History of hypersensitivity reaction to curcumin and virgin coconut oil
Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease