Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults
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
- 是
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
Bess Dawson-Hughes
Director of Bone Metabolism Laboratory
Tufts University
