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临床试验/ACTRN12616001642471
ACTRN12616001642471已完成未知

Regular fat versus reduced fat dairy consumption: a pilot study of effects on cardiometabolic and gut health in young children

Edith Cowan University0 个研究点目标入组 55 人开始时间: 2016年11月28日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
55

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
4 Years 至 6 Years(—)
性别
All

入选标准

  • 1. Boys and girls aged four to six, inclusive, at beginning of study
  • 2. Consume at least one serve of dairy per day (e.g. 40g cheese, 250 ml milk, 200g yoghurt)
  • 3. Have more than 70% (5 of 7 days) of their dairy either consumed at home or prepared at home
  • 4. Willing to complete three x 3-day food records
  • 5. Willing to provide blood (twice) and stool samples (three times)
  • 6. Willing to attend three clinical visits at Joondalup ECU
  • 7. Not participating in any other studies which may influence the outcome variables of this study
  • 8. If probiotics are being taken, stable probiotic use over the duration of study (defined as keeping the same intake amount and type of probiotic over the study period between baseline and final assessments).

排除标准

  • Children will be ineligible to participate if they:
  • 1. Are lactose intolerant
  • 2. Are allergic to cow’s milk protein e.g. dairy products
  • 3. Have taken antibiotics within the last six months (may be reduced to three months depending on ease of recruitment)
  • 4. Have any digestive disorder which may affect nutrient absorption and gastrointestinal motility such as Coeliac disease, Irritable Bowel Disease/Disorder, ulcerative colitis or Crohn’s Disease
  • 5. Have a history of regular intestinal discomfort (e.g. diarrhoea, constipation once a week or more frequently);
  • 6. Have had any surgery involving the gastro-intestinal tract
  • 7. Have diabetes or diagnosed metabolic syndrome
  • 8. Are taking any medication that will significantly alter the measurements of the primary outcome variables, including anti-hypertensives or lipid-lowering medications
  • 9. Have or have had any cardiovascular events or diagnosed cardiovascular disease or metabolic disease
  • 10. Have a body weight lower than 9.5 kg.

研究者

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