Golden Rice Cookies With Piper Crocatum for Blood Glucose Control and Quality of Life in People Living With HIV With Hyperglycemia
NCT ID: NCT07187648
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2025-12-01
2026-02-28
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
35 Years
59 Years
ALL
No
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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Deni Wardani
Principal Investigator
Central Contacts
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References
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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.
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.
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.
Related Links
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Official website of the Faculty of Nursing, Universitas Hasanuddin provides information on academic programs (including Master of Nursing ), research activities, organizational structure, and institutional collaborations.
Other Identifiers
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UH2506067
Identifier Type: -
Identifier Source: org_study_id
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