Golden Rice Cookies With Piper Crocatum for Blood Glucose Control and Quality of Life in People Living With HIV With Hyperglycemia
GRC-HIV
The Effect of Golden Rice Cookies With Piper Crocatum on Fasting Blood Sugar and Quality of Life in People Living With HIV With Hyperglycemia
1 other identifier
interventional
102
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Aug 2025
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 7, 2025
CompletedFirst Posted
Study publicly available on registry
September 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedApril 15, 2026
April 1, 2026
4 months
September 7, 2025
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Baseline and 28 days
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
Baseline and 28 days
Study Arms (2)
Golden Rice Cookies With Piper crocatum
EXPERIMENTALParticipants 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.
so-Caloric Cookies Without Golden Rice and Piper crocatum
PLACEBO 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Puskesmas Ujung Pandang Baru
Makassar, South Sulawesi, 92173, Indonesia
Related Publications (3)
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.
PMID: 19369372RESULTSetyawati 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.
PMID: 34867030RESULTZuniga 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.
PMID: 31789685RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Only participants are blinded to group assignment. The intervention and control cookies are made to appear similar in packaging and portion, so participants do not know whether they are receiving Golden Rice Cookies with Piper crocatum or control cookies.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2025
First Posted
September 23, 2025
Study Start
August 1, 2025
Primary Completion
November 30, 2025
Study Completion
November 30, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.