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临床试验/NCT07298304
NCT07298304已完成不适用

The Effect of Substituting White Rice With Sorghum Rice on Pancreatic Beta-Cell Function and Insulin Resistance in Prediabetes

Dr. Soetomo General Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Change in Serum Leptin

研究概览

简要总结

Prediabetes is a condition where blood sugar levels are higher than normal but not yet high enough to be diagnosed as diabetes. Without lifestyle changes, people with prediabetes often develop type 2 diabetes, a serious disease affecting millions worldwide. Diet plays a crucial role in preventing this progression, and replacing refined grains like white rice with whole grains may help improve metabolic health.

This study investigated whether eating sorghum rice-a nutritious whole grain rich in fiber and natural antioxidants-could affect leptin levels in people with prediabetes. Leptin is a hormone produced by fat cells that helps regulate appetite and energy use. In people with obesity and prediabetes, leptin levels are often abnormally high, which can contribute to insulin resistance and weight gain.

The investigators studied 26 police officers with prediabetes in Indonesia, randomly dividing them into two groups. One group ate sorghum rice instead of white rice for seven consecutive days, while the other group continued eating white rice. Both groups received standard education about healthy eating and exercise. The investigators measured their leptin levels before and after the week-long intervention.

Our hypothesis was that replacing white rice with sorghum rice would significantly lower leptin levels.

详细描述

This open-label randomized pre-post experimental study was designed to evaluate the metabolic effects of short-term sorghum rice consumption on serum leptin levels in prediabetic individuals. The study was conducted over a two-month period (March to April 2022) at the Bojonegoro Police Polyclinic and Bojonegoro Bhayangkara Hospital in East Java, Indonesia.

Rationale and Background The study addresses a critical gap in understanding dietary interventions for prediabetes management in Indonesia, where white rice consumption is a dominant dietary pattern associated with increased type 2 diabetes risk. Sorghum (Sorghum bicolor L.) represents a promising functional whole grain alternative, containing high levels of dietary fiber, resistant starch, and phenolic compounds with antioxidant properties. These bioactive components may influence adipokine profiles, particularly leptin, an adipocyte-derived hormone that plays a central role in energy homeostasis and is frequently dysregulated in prediabetic states. The study specifically targeted police officers, a population with unique physical activity patterns and occupational stress factors that may influence metabolic responses.

Twenty-six prediabetic participants were recruited through simple random sampling and randomly assigned in a 1:1 ratio to either the intervention (sorghum rice) group or the control (white rice) group, with 13 participants in each arm. The sample size was calculated using a standard formula for comparing numerical data between two independent groups, accounting for expected differences in leptin levels based on preliminary data and published literature. Randomization was performed to minimize selection bias and ensure comparable baseline characteristics between groups.

Participants in the intervention group completely substituted their regular white rice intake with sorghum rice for seven consecutive days. The sorghum rice was prepared according to standardized cooking procedures supervised by a registered dietitian to ensure consistency in preparation methods and palatability. The daily amount of sorghum or white rice consumed was individually calculated based on each participant's total daily energy requirements, determined using standard anthropometric measurements and physical activity assessments. This personalized approach ensured that participants maintained their usual caloric intake while only varying the grain type consumed.

The control group continued their habitual white rice consumption throughout the study period. Both groups received identical standardized lifestyle education sessions focusing on balanced nutrition principles and the importance of regular physical activity in prediabetes management, ensuring that any observed differences could be attributed to the grain substitution rather than differential educational interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 58 years
  • Diagnosed with prediabetes which met one of the criteria per PERKENI 2021 as follow:
  • Fasting plasma glucose 100-125 mg/dL
  • 2-hour postprandial glucose 140-199 mg/dL
  • HbA1c 5.7-6.4%
  • Willing to comply with dietary monitoring and lifestyle instructions
  • Active duty police officers

排除标准

  • Pregnancy
  • History of malignancy
  • Diagnosed diabetes mellitus
  • Acute infection
  • Severe hepatic or renal impairment
  • Current use of medication such as: glucose-lowering, corticosteroid, or anti-obesity medications

结局指标

主要结局

Change in Serum Leptin

时间窗: From Baseline to day 7

Change in serum leptin concentration from baseline to day 7, measured using enzyme-linked immunosorbent assay (ELISA). Delta leptin (Δ leptin) calculated as the difference between post-intervention and pre-intervention leptin levels. Time Frame: Baseline (Day 0) and Day 7 (after 7-day intervention)Unit of Measure: Nanograms per milliliter (ng/mL)

次要结局

  • Serum Leptin Levels at Baseline(day 0, before intervention)

研究者

发起方
Dr. Soetomo General Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Sony Wibisono M dr., SpPD., KEMD

Principal Investigator Sony Wibisono M dr., Sp.PD., KEMD, PhD

Dr. Soetomo General Hospital

研究点 (2)

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