The Effect of Golden Rice Cookies With Piper Crocatum on Fasting Blood Sugar and Quality of Life in People Living With HIV With Hyperglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Fasting Plasma Glucose
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Golden Rice Cookies With Piper crocatum (Dietary Supplement)
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.
干预措施: Iso-Caloric Control Cookies (Placebo) (Other)
结局指标
主要结局
Change in Fasting Plasma Glucose
时间窗: Baseline and 28 days
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
Change in Health-Related Quality of Life
时间窗: Baseline and 28 days
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
次要结局
未报告次要终点
研究者
Deni Wardani
Principal Investigator
Hasanuddin University