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

Hasanuddin University

Status: Not yet enrolling

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

Treatments: Other: Iso-Caloric Control Cookies (Placebo); Dietary Supplement: Golden Rice Cookies With Piper crocatum

Study type: Interventional

Funder types: Other

Identifiers

NCT07187648

UH2506067

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 35 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups, including a placebo group

Golden Rice Cookies With Piper crocatum

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Golden Rice Cookies With Piper crocatum

so-Caloric Cookies Without Golden Rice and Piper crocatum

Placebo Comparator group

Description:

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.

Treatment:

Other: Iso-Caloric Control Cookies (Placebo)