Golden Rice Cookies With Piper Crocatum for Blood Glucose Control and Quality of Life in People Living With HIV With Hyperglycemia (GRC-HIV)

April 10, 2026 updated by: Deni Wardani, Hasanuddin University

The Effect of Golden Rice Cookies With Piper Crocatum on Fasting Blood Sugar and Quality of Life in People Living With HIV With Hyperglycemia

The goal of this clinical trial is to learn if Golden Rice Cookies with Piper crocatum can help improve fasting blood sugar and quality of life in people living with HIV who have hyperglycemia (GRC-HIV). It will also learn about the safety and acceptability of this dietary intervention.

The main questions it aims to answer are:

Does Golden Rice Cookies with Piper crocatum lower fasting blood sugar levels in PLHIV with hyperglycemia? Does Golden Rice Cookies with Piper crocatum improve quality of life in PLHIV with hyperglycemia? Researchers will compare Golden Rice Cookies with Piper crocatum to control cookies (iso-caloric cookies without Golden Rice and Piper crocatum) to see if Golden Rice Cookies are effective.

Participants will:

Consume either Golden Rice Cookies with Piper crocatum or control cookies every day for 28 days Visit the clinic at baseline and follow-up for checkups, laboratory tests, and questionnaires Record their daily cookie consumption and any symptoms or side effects in a diary

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

People living with HIV (PLHIV) are at higher risk of developing hyperglycemia due to long-term antiretroviral therapy (ART), metabolic complications, and lifestyle factors. Hyperglycemia not only worsens the prognosis of HIV but also negatively affects quality of life. Dietary interventions using functional foods may provide a safe and acceptable strategy to address this issue.

Golden Rice is biofortified with β-carotene, which has been associated with improved insulin sensitivity and reduced glycemic response. Piper crocatum (red betel leaf) contains polyphenols, flavonoids, and tannins with antidiabetic, antioxidant, and anti-inflammatory properties. Combining Golden Rice and Piper crocatum in a practical cookie form offers a potentially effective and acceptable intervention for PLHIV with hyperglycemia.

This trial is designed to evaluate whether daily consumption of Golden Rice Cookies enriched with Piper crocatum can improve fasting plasma glucose and health-related quality of life in PLHIV with hyperglycemia compared to iso-caloric control cookies. The findings may contribute to evidence-based dietary strategies to improve metabolic outcomes and well-being in PLHIV.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 92173
        • Puskesmas Ujung Pandang Baru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HIV positive diagnosis based on medically documented serological test results (ELISA/Western Blot/rapid test).
  • Age 35-59 years.
  • Suffering from hyperglycemia, defined by a Fasting Blood Sugar (FBS) value of ≥ 100 mg/dl (prediabetes or diabetes), according to ADA (American Diabetes Association) standards and a physician's report.
  • Taking antiretroviral therapy (ART) for at least the past 2 years to ensure stable clinical status.
  • CD4 count ≥ 200 cells/mm³, to exclude participants with severely compromised immunity that could impact metabolism and quality of life.
  • Not currently undergoing strict diet therapy or other nutritional interventions to avoid nutritional bias.
  • Willing to sign informed consent and participate in all stages of the study

Exclusion Criteria:

  • Having acute complications of HIV/AIDS, such as severe opportunistic infections, that may interfere with interventions or quality of life measurements.
  • Having a history of other chronic diseases that affect glucose metabolism, such as advanced chronic kidney disease, active cancer, hyperthyroidism, or severe liver disease.
  • Using medications that can affect blood sugar levels (e.g., steroids, thiazide diuretics, or other hyperglycemic drugs) in the past month.
  • Allergies to ingredients in Golden Rice Cookies (Red Rice) or Piper crocatum.
  • Being pregnant or breastfeeding.
  • Participating in other nutrition intervention programs, intensive physical training.
  • Inability to read or understand instructions (e.g., due to severe cognitive impairment) that may interfere with completing the quality of life questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Golden Rice Cookies With Piper crocatum
Participants in this group will consume Golden Rice cookies enriched with Piper crocatum. Each participant will receive 20 g twice daily (40 g/day total) for 28 days. The cookies are designed to be iso-caloric with the control cookies and packaged identically to maintain participant blinding.
Dietary supplement: Golden Rice Cookies With Piper crocatum
Golden Rice cookies enriched with Piper crocatum were formulated as a functional food containing β-carotene and bioactive compounds (polyphenols, flavonoids, tannins). Participants in the experimental arm consume 20 g twice daily (40 g/day total) for 28 days. The cookies are iso-caloric with control cookies but differ by inclusion of Golden Rice and Piper crocatum.
Placebo Comparator: so-Caloric Cookies Without Golden Rice and Piper crocatum
Participants in this group will consume placebo cookies made from standard flour without Golden Rice and without Piper crocatum. Each participant will receive 20 g twice daily (40 g/day total) for 28 days. The cookies are calorie-matched and designed to resemble the intervention cookies in appearance but do not contain the active ingredients.
Other: Iso-Caloric Control Cookies (Placebo)
Iso-caloric cookies made from standard flour without Golden Rice and without Piper crocatum. Participants in the control arm consume 20 g twice daily (40 g/day total) for 28 days. The cookies are designed to match the intervention cookies in calories and appearance but do not contain the active ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose
Time Frame: Baseline and 28 days

Change in fasting plasma glucose level from baseline to Day 28, measured using enzymatic method after 8-10 hours of fasting. Measurement scale:

  1. <100 mg/dL = Normal
  2. 100-125 mg/dL = Prediabetes
  3. ≥126 mg/dL = Diabetes Mellitus
Baseline and 28 days
Change in Health-Related Quality of Life
Time Frame: Baseline and 28 days

Change in quality of life score assessed using WHOQOL-HIV BREF questionnaire from baseline to Day 28.

Measurement results:

  1. Low Quality of Life: <41
  2. Moderate Quality of Life: 41-60
  3. High Quality of Life ≥60
Baseline and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

September 7, 2025

First Submitted That Met QC Criteria

September 22, 2025

First Posted (Actual)

September 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UH2506067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because of confidentiality and privacy considerations for people living with HIV, as well as institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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