The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients: a Randomized Double-blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs)
研究概览
简要总结
There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. This is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. Firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.
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, Outcomes Assessor)
盲法说明
The all details of groups assignment are arranged and controlled by the research designers. The color, shape, and external packaging of the yeast beta-glucan and placebo are consistent. Each bottle of capsules will be marked with the name (or identify number) of the participants by research designers. Thus, the grouping of participants is blind to the rest of the researchers (like outcomes assessors).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-65 years
- •Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999
排除标准
- •Allergic to test substances
- •Known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases
- •Known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently
- •Usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks
- •Unable to cooperate with researchers or maintain ordinary dietary habit
研究组 & 干预措施
Intervention group
Ingredients: yeast beta-glucan, and capsule shell Capsule, per capsule with 500mg insoluble beta-glucan, twice a day, 1 capsule each time.
The intervention period is about 3 months.
干预措施: Yeast Beta-glucan (Dietary Supplement)
Placebo group
Ingredients: starch, and capsule shell Capsule, per capsule with 500mg starch, twice a day, 1 capsule each time. The intervention period is about 3 months.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs)
时间窗: At 0 week, 6th week, 12th week in the intervention period.
Extract and isolate PBMCs from participants. Using flow cytometry to detect the differentiation rates of some PBMCs（Peripheral Blood Mononuclear Cells）inculding T, B, NK, CD4+, CD8+, CD19+, CD138+, CD3+ and CD45+ cells
Changes in inflammatory factors
时间窗: At 0 week, 6th week, 12th week in the intervention period.
Using ELISA to detect the expression level of TNF-α, IL-6, IL-1β, IL-12, IL-10, TGF-β
Changes in blood glucose level
时间窗: At 0 week, 12th week in the intervention period.
FPG(fasten plasma glucose), OGTT（oral glucose tolerance test）
Changes in gut microbiota
时间窗: At 0 week, 6th week, 12th week in the intervention period.
High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform.
Changes in RTI(respiratory tract infection)
时间窗: Every week across the intervention peroid，an average of 3 months.
Observe the clinical symptoms of respiratory infections in two groups of patients
Changes in islet function
时间窗: At 0 week, 12th week in the intervention period.
C-peptide level
次要结局
- Changes in SCFA (short chain fatty acids)(At 0 week, 6th week, 12th week in the intervention period.)
- Changes in blood lipids profile(At 0 week, 12th week in the intervention period.)
- Changes in hepatorenal function(At 0 week, 12th week in the intervention period.)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology