Effects of Zinc Supplementation on Patients With Elevated Glycemic Status: A Randomized Double-blind Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 主要终点
- Concentration of fasting blood glucose (FBG)
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.
详细描述
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.
About 124 patients aged 18 years or older, had resided locally for at least one year, with elevated glycemic status will be enrolled in the study. Patients with elevated glycemic status are defined as meeting any of the following criteria:
- Fasting blood glucose ≥ 6.1 mmol/L;
- Glycated hemoglobin (HbA1c) ≥ 5.7%;
- Oral glucose tolerance test (OGTT) 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;
- Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
Eligible participants will be assigned by chance to one of two groups: (1) daily zinc supplementation: zinc-enriched yeast capsules (4 mg); (2) daily edible yeast placebo capsules (not zinc-enriched) (4mg). Randomization will be conducted.
At enrollment, baseline questionnaires are designed to collect data on sociodemographic factors, lifestyle habits, health status, and medical conditions. Participants in both groups will take one capsule that contained either Zinc-enriched yeast or edible yeast placebo each day until the end of the intervention period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting blood glucose ≥ 6.1 mmol /L;
- •HBA1c ≥ 5.7%;
- •OGTT 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;
- •Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
排除标准
- •Age < 18 years, or currently pregnant;
- •Individuals with severe obesity, thyroid disease, cardiovascular or cerebrovascular diseases, or other serious health conditions;
- •Individuals with a previous diagnosis of type 2 diabetes currently receiving insulin therapy;
- •Individuals who have taken zinc-related supplements within three months prior to baseline inclusion;
- •Individuals using other nutritional supplements or with poor lifestyle habits;
- •Individuals with unstable body weight in the past three months (fluctuations > 5 kg);
- •Individuals with a history of major surgery within the past three months or planned major surgery within the next month;
- •Individuals allergic to the intervention materials;
- •Individuals who did not adhere to the prescribed consumption of the study product, affecting efficacy or safety assessment;
- •Individuals with positive urinary protein or serum creatinine greater than 1.2 times the upper limit of normal (men: serum creatinine > 133.2 μmol/L, women: serum creatinine > 97.2 μmol/L) at screening;
- •Individuals with elevated alanine aminotransferase (ALT) levels at screening (men: ALT > 50 U/L, women: ALT > 35 U/L).
研究组 & 干预措施
Zinc supplementation
zinc-enriched yeast capsule, 15mg/d
干预措施: Zinc-enriched yeast capsule (Dietary Supplement)
Edible yeast placebo
Edible yeast placebo capsule, 15mg/d
干预措施: Edible yeast placebo capsule (Dietary Supplement)
结局指标
主要结局
Concentration of fasting blood glucose (FBG)
时间窗: 0 week, 12th week, and 24th week in the intervention period
Concentration of FBG, measured in mmol/L
Glycated hemoglobin (HbA1c)
时间窗: 0 week, 12th week, and 24th week in the intervention period
Concentration of HbA1c, measured in the percentage of hemoglobin
次要结局
- Activity of Cu-Zn superoxide dismutase (SOD)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of homocysteine (HCY)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of plasma albumin (ALB)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of fasting plasma insulin (FPI)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of plasma c-peptide(0 week, 12th week, and 24th week in the intervention period)
- Homeostatic model assessment of insulin resistance (HOMA-IR)(0 week, 12th week, and 24th week in the intervention period)
- Homeostatic model assessment of β-cell function (HOMA-β)(0 week, 12th week, and 24th week in the intervention period)
- Homeostatic model assessment of insulin sensitivity (HOMA-S)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of blood lipids(0 week, 12th week, and 24th week in the intervention period)
- Concentration of C-reactive protein (CRP)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of interleukin-6 (IL-6)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of malondialdehyde (MDA)(0 week, 12th week, and 24th week in the intervention period)
- Concentration of plasma creatinine(0 week, 12th week, and 24th week in the intervention period)
- Concentration of plasma zinc(0 week, 12th week, and 24th week in the intervention period)
研究者
Zhilei Shan
Professor
Huazhong University of Science and Technology