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出境医 / 临床实验 / Effect of Dried Fruit Intake on Acid-base Balance

Effect of Dried Fruit Intake on Acid-base Balance

Study Description
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).
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE August 27, 2018
Actual Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019) 		change in 24-hour urinary NAE [ Time Frame: 12 month ]
NAE reflects net acid-base balance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • 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
  • change in 24-hour urinary N-telopeptide [ Time Frame: 12 months ]
    a measure of bone resorption
  • 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:)
  • change in bone mineral density at the total body [ Time Frame: 12 months ]
    measured by DXA
  • change in body weight [ Time Frame: 12 months ]
    measured on a standard scale
  • change in grip strength [ Time Frame: 12 months ]
    hand grip strength in kilograms assessed by a hand held dynamometer
  • 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
  • change in bone mineral density of the spine [ Time Frame: 12 months ]
    measured by DXA
  • change in bone mineral density of the hip [ Time Frame: 12 months ]
    measured by DXA
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dried Fruit Intake on Acid-base Balance
Official Title  ICMJE Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acid-Base Balance Disorder
Intervention  ICMJE Other: food - dried fruit
raisins, apricots, figs, and pineapple
Study Arms  ICMJE
  • Experimental: dried fruit
    100 g per day of dried fruit
    Intervention: Other: food - dried fruit
  • No Intervention: no dried fruit
    no intervention to be given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 27, 2020) 		109
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2019) 		90
Actual Study Completion Date  ICMJE March 17, 2020
Actual Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04030351
Other Study ID Numbers  ICMJE 2980
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bess Dawson-Hughes, Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE Tufts Medical Center
Investigators  ICMJE Not Provided
PRS Account Tufts University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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