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临床试验/NCT02377076
NCT02377076已完成不适用

Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics

Federal University of Vicosa2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
HbA1c

研究概览

简要总结

Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of dietary calcium supplementation in permeability and intestinal microbiota in overweight type 2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study. Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL) or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed containing 800 mg of calcium from dietary sources / day. During intervention period, a beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of calcium as milk powder) will be ingested in the laboratory. Food intake, body composition (total body fat and fat free mass) and anthropometric measures (waist circumference, waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers) will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or non-parametric tests will be applied, according to the distribution of variables (level of statistical significance of 5%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes mellitus using oral hypoglycemic medication
  • Overweight (body mass index between 25 and 34.9 kg / m2)
  • Usual intake of calcium less than 600 mg / day
  • Level of physical activity light to moderate
  • HbA1c above 7% or fasting glucose above 130 mg / dl

排除标准

  • Use of calcium, vitamin D, magnesium, zinc, chromium, copper supplements or medication affecting the metabolism of these micronutrients,
  • Use of drugs, herbs or diets that reduce appetite and body weight
  • Estrogen replacement
  • Gain or loss of at least 5 kg in the last 3 months
  • Recent change in the level of physical activity
  • Aversion or intolerance to food provided in the study
  • Alcohol consumption of more than 2 doses / day (more than 50g ethanol / day)
  • Eating disorders
  • Endocrine disease, renal disease, hepatic disease or malabsorption syndrome that alters calcium metabolism
  • History of recurrent nephrolithiasis
  • Caffeine consumption of> 300 mg / day
  • Pregnancy, lactation or postmenopausal
  • Cardiovascular, infectious, inflammatory, thyroid, liver, kidney or intestinal disease
  • Use of anti-inflammatory, antacids, antibiotics and laxatives drugs
  • Major gastrointestinal surgery.

研究组 & 干预措施

DAIRY

Experimental

Dietary calcium supplementation

干预措施: Dietary calcium supplementation (Dietary Supplement)

CONTROL

Placebo Comparator

Control

干预措施: Control (Dietary Supplement)

结局指标

主要结局

HbA1c

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Federal University of Vicosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Junia Maria Geraldo Gomes

Dr

Federal University of Vicosa

研究点 (2)

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