- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04030351
Effect of Dried Fruit Intake on Acid-base Balance
October 27, 2020 updated by: Bess Dawson-Hughes, Tufts University
Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02111
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dried fruit
100 g per day of dried fruit
|
raisins, apricots, figs, and pineapple
|
No Intervention: no dried fruit
no intervention to be given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in 24-hour urinary NAE
Time Frame: 12 month
|
NAE reflects net acid-base balance
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
change in 24-hour urinary N-telopeptide
Time Frame: 12 months
|
a measure of bone resorption
|
12 months
|
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:)
|
12 months
|
change in bone mineral density at the total body
Time Frame: 12 months
|
measured by DXA
|
12 months
|
change in body weight
Time Frame: 12 months
|
measured on a standard scale
|
12 months
|
change in grip strength
Time Frame: 12 months
|
hand grip strength in kilograms assessed by a hand held dynamometer
|
12 months
|
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
|
12 months
|
change in bone mineral density of the spine
Time Frame: 12 months
|
measured by DXA
|
12 months
|
change in bone mineral density of the hip
Time Frame: 12 months
|
measured by DXA
|
12 months
|
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
|
12 months
|
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 months
|
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
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2018
Primary Completion (Actual)
March 17, 2020
Study Completion (Actual)
March 17, 2020
Study Registration Dates
First Submitted
July 18, 2019
First Submitted That Met QC Criteria
July 22, 2019
First Posted (Actual)
July 23, 2019
Study Record Updates
Last Update Posted (Actual)
October 29, 2020
Last Update Submitted That Met QC Criteria
October 27, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2980
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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