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

NCT06676124 | Completed DMC

• 2 other identifiers: PROT-2024-UH1220/UN4.14.1/TP.01.02/2024
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early Renal Dysfunction; Diabetes Complications; Piper crocatum; Antioxidants; Anti-inflammatory; Renal Biomarkers; Functional Foods

Outcome Measures

Primary Outcomes (1)

• Change in MMP-9 and NGAL Levels in Diabetic Patients with Early Renal Dysfunction

  This measure evaluates the change in serum levels of matrix metalloproteinase-9 (MMP-9) and neutrophil gelatinase-associated lipocalin (NGAL) in diabetic patients with early renal dysfunction after 12 weeks of intervention. MMP-9 is associated with renal inflammation and extracellular matrix remodeling, while NGAL is a marker of tubular injury and oxidative stress. Blood samples will be collected at baseline and at the end of the 12-week period, and serum levels of MMP-9 and NGAL will be quantified using validated ELISA kits. This assessment aims to determine the potential effects of the Piper crocatum intervention on renal health by observing significant changes in these biomarkers

  Baseline and 12 weeks

Study Arms (2)

Piper crocatum Cookie Group

EXPERIMENTAL

Participants in this group will receive bioactive-rich cookies containing Piper crocatum extract, known for its antioxidant and anti-inflammatory properties. They will consume two cookies daily for 12 weeks, each formulated with a standardized 10% concentration of the ethyl acetate fraction of Piper crocatum extract. The intervention aims to modulate renal biomarkers associated with diabetic nephropathy

Dietary Supplement: Piper crocatum Extract Cookie

Placebo Cookie Group

PLACEBO COMPARATOR

Participants in this group will receive placebo cookies that are identical in appearance, taste, and texture to the Piper crocatum cookies but do not contain the active Piper crocatum extract. They will consume two cookies daily for 12 weeks. This group serves as a comparison to evaluate the effects of the Piper crocatum extract in the intervention group

Dietary Supplement: Placebo Comparator

Interventions

Piper crocatum Extract Cookie DIETARY_SUPPLEMENT

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

Piper crocatum Cookie Group

Placebo Comparator DIETARY_SUPPLEMENT

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.

Placebo Cookie Group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged over 20 years.
• Diagnosed with Diabetes Mellitus (DM).
• Serum urea levels above 43 mg/dL or serum creatinine levels above 0.90 mg/dL.

You may not qualify if:

• Pregnant or breastfeeding individuals.
• Patients with other medical conditions that require intensive care.
• Patients currently undergoing therapy for hypoalbuminemia.
• Known allergies to any ingredients in the study cookies.
• Other chronic conditions that might interfere with the study protocol (e.g., severe cardiovascular disease).

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Public Health Center in Makassar, Indonesia

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (15)

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Related Links

• This study examines the effect of Piper crocatum-enriched Golden Rice cookies on diabetic foot ulcer prevention by modulating MMP-9 levels. The cookies are designed to reduce inflammation and support diabetic foot health through dietary intervention

MeSH Terms

Conditions

Diabetic Nephropathies; Inflammation; Renal Insufficiency; Diabetes Complications

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blinded. Participants, care providers, investigators, and outcomes assessors are all masked to group assignments. Cookies for both the intervention and placebo groups are identical in appearance, taste, and packaging to prevent any indication of group allocation. The randomization and coding were handled by an independent party, and group assignments were concealed using sealed, opaque envelopes. All study personnel involved in data collection, analysis, and monitoring were also blinded to maintain the integrity of the results and minimize bias throughout the trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Surgical Nursing

Model Details: Two parallel groups: one group receives Piper crocatum cookies, and the other group receives placebo cookies for 12 weeks

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: June 15, 2024
• Primary Completion: September 5, 2024
• Study Completion: September 16, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)