KurCoSmart Effects on People With Type 2 DM

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Diabetes Mellitus, Type 2; Body Weight; Insulin Resistance
• Intervention / Treatment: Dietary supplement: Curcumin and virgin coconut oil extract (KurCo Smart)

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Sukoharjo, Central Java, Indonesia, 57161
      • UNS Hospital
      • Contact: Desy Puspa Putri, Master; Phone Number: +6281283284827; Email: desypuspa@staff.uns.ac.id
      • Principal Investigator: Nurhasan Agung Prabowo, Master
      • Principal Investigator: Yulia Sari, Doctor
      • Sub-Investigator: Desy Puspa Putri, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Subject's height and body weight	Change of BMI at 1 Months
Blood Pressure	Subject's blood pressure	Change fof blood prssure at 1 Months

Collaborators and Investigators

• Sponsor: Universitas Sebelas Maret

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: diabetes mellitus; curcumin; coconut oil
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation; Insulin Resistance; Body Weight; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: KurCoSmart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be restricted for this study purpose only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No