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MMP-9/NGAL Modulation by Piper Crocatum in Early Diabetic Nephropathy

NCT06676124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2024-11-06

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether functional foods made with Piper crocatum (red betel leaf) can reduce kidney damage markers in people with diabetes who have early kidney dysfunction. Researchers aim to find out if these foods can help decrease inflammation and oxidative stress, which are known to worsen kidney problems in diabetes.

Participants are divided into two groups: one group will consume cookies containing Piper crocatum extract, while the other group will consume similar cookies without the extract (placebo). They will eat these cookies twice a day for 12 weeks.

This study will measure changes in two main kidney damage markers-MMP-9 and NGAL-before and after the intervention to see if Piper crocatum helps lower these markers and supports kidney health.

Conditions

  • Early Renal Dysfunction in Diabetes
  • Diabetic Nephropathy
  • Inflammation and Oxidative Stress in Diabetic Patients

Interventions

DIETARY_SUPPLEMENT

Piper crocatum Extract Cookie

Participants in the intervention group will receive cookies containing a standardized 10% ethyl acetate extract of Piper crocatum, known for its antioxidant and anti-inflammatory properties. These cookies will be consumed twice daily for 12 weeks. The intervention aims to assess the effects of Piper crocatum on renal biomarkers, such as MMP-9 and NGAL, in diabetic patients with early renal dysfunction

DIETARY_SUPPLEMENT

Placebo Comparator

Participants in the placebo group will receive cookies that are identical in appearance, taste, and texture to the active Piper crocatum cookies but do not contain the Piper crocatum extract. These cookies will be consumed twice daily for 12 weeks, serving as a control to assess the effects of the active intervention on renal biomarkers associated with diabetic nephropathy.

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2024-09-05
Completion
2024-09-16

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676124 on ClinicalTrials.gov