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HIV InfectionsGRC-HIVNCT07187648

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

A study testing Golden Rice Cookies With Piper crocatum in people with HIV Infections and Nutritional Intervention, run by Hasanuddin University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 59 years
What is being tested?
Golden Rice Cookies With Piper crocatum
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteIndonesia
Study dates
1 Aug 2025to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Puskesmas Ujung Pandang Baru

    Makassar, South Sulawesi, 92173

Other trials in Indonesia

About this study

Official title: 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:

Read more

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

Read the 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.

Being tested
Golden Rice Cookies With Piper crocatum, Iso-Caloric Control Cookies (Placebo)
Keywords
HIV, Golden Rice, Quality of Life, Blood Glucose
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Golden Rice Cookies With Piper crocatumDietary supplement

    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.

  • Iso-Caloric Control Cookies (Placebo)Other

    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.

Study groups in NCT07187648
Study groupRoleWhat they receive
Golden Rice Cookies With Piper crocatumExperimentalParticipants 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.
Receives: Dietary Supplement: Golden Rice Cookies With Piper crocatum
so-Caloric Cookies Without Golden Rice and Piper crocatumPlacebo comparatorParticipants 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.
Receives: Other: Iso-Caloric Control Cookies (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fasting Plasma Glucose

    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

    Measured: Baseline and 28 days

  2. Change in Health-Related Quality of Life

    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

    Measured: Baseline and 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start1 Aug 2025
  3. Primary completion30 Nov 2025
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in parallel to one of two groups: the intervention group receiving Golden Rice Cookies with Piper crocatum or the control group receiving placebo. Both groups will consume their assigned cookies daily for 28 days
Masking
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187648
Sponsor's protocol ID
UH2506067
Acronym
GRC-HIV
Status last verified
Apr 2026
First submitted
7 Sep 2025
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Tang G, Qin J, Dolnikowski GG, Russell RM, Grusak MA. Golden Rice is an effective source of vitamin A. Am J Clin Nutr. 2009 Jun;89(6):1776-83. doi: 10.3945/ajcn.2008.27119. Epub 2009 Apr 15.

    PubMed 19369372

  • Setyawati A, Wahyuningsih MSH, Nugrahaningsih DAA, Effendy C, Fneish F, Fortwengel G. Piper crocatum Ruiz & Pav. ameliorates wound healing through p53, E-cadherin and SOD1 pathways on wounded hyperglycemia fibroblasts. Saudi J Biol Sci. 2021 Dec;28(12):7257-7268. doi: 10.1016/j.sjbs.2021.08.039. Epub 2021 Aug 19.

    PubMed 34867030

  • Zuniga JA, Jang DE, Walker G, Ohueri CW, A Garcia A. Differences in Health-Related Quality of Life Predictors in People Living With HIV With and Without Diabetes. J Assoc Nurses AIDS Care. 2020 Sep-Oct;31(5):544-552. doi: 10.1097/JNC.0000000000000138.

    PubMed 31789685

Questions about this trial

What is this clinical trial studying?

A study testing Golden Rice Cookies With Piper crocatum in people with HIV Infections and Nutritional Intervention, run by Hasanuddin University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fasting Plasma Glucose (time frame: Baseline and 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187648, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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