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临床试验/NCT04299763
NCT04299763已完成2 期

Oat β-glucans as a Supplement in Chilean Subjects With Type 2 Diabetes for Metabolic Control

Centro de Estudios en Alimentación y Nutrición, Chile2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
HbA1c

研究概览

简要总结

Objective: To evaluate the effect of oat β-glucans on the satiety perception, metabolic control and intestinal microbiota of type 2 diabetics from Talca, Chile. Methodology: Clinical trial, controlled, randomized, double blind and parallel design. The recruited (40 subjects) were randomized into two groups, placebo (PL) and ß-glucan (BG). 5 gr of oat ß-glucan or placebo were delivered for 12 weeks to be added in breakfast. Blood and stool samples were requested at the beginning and at the end of the intervention. The investigators quantify: HbA1c in whole blood, fasting blood glucose, basal insulin, C-peptide, tumor necrosis factor alpha (TNF-a), interleukin (IL) 6, IL-8, IL-10, IL1β, cortisol, ghrelin, glucagon-like peptide type 1 (GLP -1), YY peptide (PYY), Resistin, Leptin and serum Lipid Profile. The subjective perception of hunger / satiety were established through an analogous visual survey. Calorie intake was determined by 24-hour recall survey. Were analyzed the phylum: Firmicutes, Bacteroidetes and Verrucomicrobia, and the populations of Bifidobacteria spp, Lactobacillus spp, butyrate producing bacteria, Akkermansia Muciniphila and total bacteria of fecal microbiota, using quantitative polymerase chain reaction (qPCR) with specific primers. All participants were instructed not to make changes in their usual eating habits, physical activity and pharmacological treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects with type 2 diabetes mellitus
  • Use of oral hypoglycemic agents (Metformin)
  • 30 to 45 years
  • More than one year and less than 10 diabetes
  • no major chronic complications
  • Hb A1c between 7 to 9%
  • BMI between 30-35 Kg / mt2.

排除标准

  • Pregnant women
  • Acute and / or chronic intestinal pathologies (malabsorption syndrome, celiac disease, chronic inflammatory bowel diseases, among others.),
  • Drugs that interfere with the microbiota (antibiotics, anti-inflammatories, laxatives, prokinetics),
  • Organic insufficiencies (cardiac, hepatic, renal, respiratory), or with immunodeficiencies (HIV, chemotherapy, radiotherapy, transplanted).
  • Presence of smoking habit.
  • Regular probiotic or prebiotic intake (more than 2 months)
  • Dipeptidyl peptidase 4 inhibitors (DPP4) and α-amylase inhibitor drugs.

结局指标

主要结局

HbA1c

时间窗: 12 weeks

Concentration of Glycated Hemoglobin A

次要结局

未报告次要终点

研究者

发起方
Centro de Estudios en Alimentación y Nutrición, Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Luis Pino Villalón

Nutritionist

University of Chile

研究点 (2)

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