Status:
NOT_YET_RECRUITING
Golden Rice Cookies With Piper Crocatum for Blood Glucose Control and Quality of Life in People Living With HIV With Hyperglycemia
Lead Sponsor:
Hasanuddin University
Conditions:
HIV Infections
Nutritional Intervention
Eligibility:
All Genders
35-59 years
Phase:
NA
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-HI...
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 wors...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT07187648
Start Date
December 1 2025
End Date
February 28 2026
Last Update
November 25 2025
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