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临床试验/NCT04030351
NCT04030351终止不适用

Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults

Tufts University2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2018年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
109
试验地点
2
主要终点
change in 24-hour urinary NAE

研究概览

简要总结

Most adults consume acid-producing diets because their high intake of protein and/or cereal grains in relation to their intake of fruits and vegetables. This study is being done to determine whether acid-base balance can be restored by the addition of dried fruits to the diet. In this study adults with low usual fruit intake will be provided with either 100 g per day of a mix of dried fruits or no dried fruit. Participants will be followed for 1 year. Acid-base status will be assessed by measuring the acid content in 24-hour urine collections.

详细描述

Most adults consume acid-producing diets because their intake of protein and/or cereal grains is high in relation to their intake of fruits and vegetables. Supplementation with alkaline salts such as potassium bicarbonate and potassium citrate have been shown to reduce 24-hr urinary net acid excretion (NAE) in healthy adults. This approach requires taking many capsules daily, in split doses after each meal with a full glass of water. An alternative and perhaps more acceptable approach to achieving acid-base balance for most adults may be to modify their diet by increasing intake of alkali-producing foods, such as fruit. Maintaining acid base balance may be important for preserving bone and muscle and renal function and other outcomes but this has not been established. The investigators propose to determine whether adults who are provided with 100 g per day of a selection of dried fruits will actually consume enough of it to correct their acid-producing diets, as evidenced by a lowering of their urinary NAE. The investigators will also determine whether and how participants will alter their overall diets or their body weight when provided with the dried fruit. The comparator group will receive no dried fruit (or other intervention).

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • usual self-reported fruit intake not greater than 2.5 servings per day
  • adequate dentition to chew dried fruit
  • willing to avoid potassium supplements during the study
  • willing to avoid antacids other than Pepto Bismol during the study

排除标准

  • diabetes or fasting plasma glucose on screening >125 mg/dl
  • untreated thyroid disease
  • untreated parathyroid disease
  • cirrhosis
  • unstable heart disease
  • osteoporosis of the spine or hip
  • alcohol use > 2 drinks per day
  • chronic diarrheal syndrome
  • estimated glomerular filtration rate < 50 ml/min
  • serum potassium >5.3 meq/L
  • abnormal serum calcium
  • dysphasia
  • malabsorption
  • inflammatory bowel disease
  • celiac disease
  • chronic constipation
  • gastric bypass surgery
  • non-English speaking Medications
  • potassium sparing diuretics
  • oral glucocorticoids
  • immunosuppressant drugs
  • anabolic steroids in last 6 months
  • estrogen in last 6 months
  • osteoporosis treatment in the last 12 months with teriparatide abaloparatide calcitonin raloxifene denosumab
  • osteoporosis treatment with a bisphosphonate in the last 2 years
  • regular use of antacids > 3 times per week
  • regular use of laxatives > 3 times per week
  • any medication taken to alter appetite

结局指标

主要结局

change in 24-hour urinary NAE

时间窗: 12 month

NAE reflects net acid-base balance

次要结局

  • change in bone mineral density at the total body(12 months)
  • change in body weight(12 months)
  • change in bone mineral density of the spine(12 months)
  • change in bone mineral density of the hip(12 months)
  • Health Aging and Body Composition- gait speed(12 months)
  • Health Aging and Body Composition-physical performance battery(12 months)
  • rate of adherence with dried fruit(12 months)
  • change in 24-hour urinary N-telopeptide(12 months)
  • change in fat to lean tissue mass ratio(12 months)
  • change in grip strength(12 months)
  • Mediterranean diet score(12 months)
  • Health Aging and Body Composition-leg strength(12 months)
  • Health Aging and Body Composition - standing balance(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bess Dawson-Hughes

Director of Bone Metabolism Laboratory

Tufts University

研究点 (2)

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