Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics
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
- 否
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
Dietary calcium supplementation
干预措施: Dietary calcium supplementation (Dietary Supplement)
CONTROL
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
Dr Junia Maria Geraldo Gomes
Dr
Federal University of Vicosa
