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

NCT07187648

CompletedNA

Sponsor: Hasanuddin University

Conditions: HIV Infections, Nutritional Intervention, Blood Glucose, Quality of Life

Interventions: Golden Rice Cookies With Piper crocatum, Iso-Caloric Control Cookies (Placebo)

Countries: Indonesia

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

Eligibility overview

Sex: ALL

Age: 35 Years to 59 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Makassar, South Sulawesi, Indonesia