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Effect of Dried Fruit Intake on Acid-base Balance

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Tufts University

Status

Terminated

Conditions

Acid-Base Balance Disorder

Treatments

Other: food - dried fruit

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

109 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

109 participants in 2 patient groups

dried fruit
Experimental group
Description:
100 g per day of dried fruit
Treatment:
Other: food - dried fruit
no dried fruit
No Intervention group
Description:
no intervention to be given

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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