Clinical trial NCT04030351: Effect of Dried Fruit Intake on Acid-base Balance
Official title: Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acid-Base Balance Disorder
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
First posted: 2019-07-23
Enrollment: 109
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

Conditions

* 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

Primary outcomes:
measure: change in 24-hour urinary NAE
timeFrame: 12 month
Secondary outcomes:
measure: rate of adherence with dried fruit
timeFrame: 12 months
measure: change in 24-hour urinary N-telopeptide
timeFrame: 12 months
measure: change in fat to lean tissue mass ratio
timeFrame: 12 months
measure: change in bone mineral density at the total body
timeFrame: 12 months
measure: change in body weight
timeFrame: 12 months
measure: change in grip strength
timeFrame: 12 months
measure: Mediterranean diet score
timeFrame: 12 months
measure: change in bone mineral density of the spine
timeFrame: 12 months
measure: change in bone mineral density of the hip
timeFrame: 12 months
measure: Health Aging and Body Composition-leg strength
timeFrame: 12 months
measure: Health Aging and Body Composition - standing balance
timeFrame: 12 months
measure: Health Aging and Body Composition- gait speed
timeFrame: 12 months
measure: Health Aging and Body Composition-physical performance battery
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
References: