KurCoSmart Effects on People With Type 2 DM

NCT05407467 | Unknown Phase 1 DMC

• 1 other identifier: KurCoSmart
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation; Body Weight

Keywords

curcumin; coconut oil; diabetes mellitus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Body Mass Index

  Change of BMI at 1 Months

• Blood Pressure

  Change fof blood prssure at 1 Months

Study Arms (2)

Control Group

NO INTERVENTION

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

Interventional Group

EXPERIMENTAL

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)

Interventions

Curcumin and virgin coconut oil extract (KurCo Smart) DIETARY_SUPPLEMENT

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

Interventional Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Type 2 DM
• Signing consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

UNS Hospital

Sukoharjo, Central Java, 57161, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation; Body Weight; Diabetes Mellitus

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Central Study Contacts

Nurhasan Agung Prabowo, MD

CONTACT

6282328010430; dr.Nurhasan21@staff.uns.ac.id

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)