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Effect of Dried Fruit Intake on Acid-base Balance

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ClinicalTrials.gov Identifier: NCT04030351
Recruitment Status : Terminated (Institution shut down due to COVID-19)
First Posted : July 23, 2019
Last Update Posted : October 29, 2020
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by (Responsible Party):
Bess Dawson-Hughes, Tufts University

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.

Condition or disease Intervention/treatment Phase
Acid-Base Balance Disorder Other: food - dried fruit Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : March 17, 2020

Arm Intervention/treatment
Experimental: dried fruit
100 g per day of dried fruit
Other: food - dried fruit
raisins, apricots, figs, and pineapple

No Intervention: no dried fruit
no intervention to be given



Primary Outcome Measures :
  1. change in 24-hour urinary NAE [ Time Frame: 12 month ]
    NAE reflects net acid-base balance


Secondary Outcome Measures :
  1. rate of adherence with dried fruit [ Time Frame: 12 months ]
    weight of dispensed fruit consumed, calculated as weight of fruit dispensed minus the weight of fruit returned

  2. change in 24-hour urinary N-telopeptide [ Time Frame: 12 months ]
    a measure of bone resorption

  3. change in fat to lean tissue mass ratio [ Time Frame: 12 months ]
    a measure of change in body composition by dual-energy x-ray absorptiometry (DXA:)

  4. change in bone mineral density at the total body [ Time Frame: 12 months ]
    measured by DXA

  5. change in body weight [ Time Frame: 12 months ]
    measured on a standard scale

  6. change in grip strength [ Time Frame: 12 months ]
    hand grip strength in kilograms assessed by a hand held dynamometer

  7. Mediterranean diet score [ Time Frame: 12 months ]
    a 14-item scale of adherence to a healthy Mediterranean style diet; a higher score represents a better diet

  8. change in bone mineral density of the spine [ Time Frame: 12 months ]
    measured by DXA

  9. change in bone mineral density of the hip [ Time Frame: 12 months ]
    measured by DXA

  10. Health Aging and Body Composition-leg strength [ Time Frame: 12 months ]
    defined as ability to do 5 repeated chair stands; assessed on a 4-point scale; a higher score represents a better performance

  11. Health Aging and Body Composition - standing balance [ Time Frame: 12 months ]
    defined as ability to stand in tandem position measured on a 4-point scale; a higher score represents a better performance

  12. Health Aging and Body Composition- gait speed [ Time Frame: 12 months ]
    defined as usual gait speed of performing a 6-meter walk; assessed on a 4-point scale; a higher score represents a better performance

  13. Health Aging and Body Composition-physical performance battery [ Time Frame: 12 months ]
    The total score is 12 points, representing the sum of the 4-point scores of the 3 domains (strength, balance and gait speed). A higher score represents a better performance.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030351


Locations
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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Tufts Medical Center
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Responsible Party: Bess Dawson-Hughes, Director of Bone Metabolism Laboratory, Tufts University
ClinicalTrials.gov Identifier: NCT04030351    
Other Study ID Numbers: 2980
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No