Acid-Base Balance DisorderNCT04030351
Effect of Dried Fruit Intake on Acid-base Balance
A study testing food - dried fruit in people with Acid-Base Balance Disorder, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acid-Base Balance Disorder
- What is being tested?
- food - dried fruit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Conditions
- diabetes or fasting plasma glucose on screening >125 mg/dl
- untreated thyroid disease
- untreated parathyroid disease
- cirrhosis
- unstable heart disease
Show all 29Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: 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.
Read the 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).
- Conditions
- Acid-Base Balance Disorder
- Being tested
- food - dried fruit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food - dried fruitOther
raisins, apricots, figs, and pineapple
| Study group | Role | What they receive |
|---|---|---|
| dried fruit | Experimental | 100 g per day of dried fruit Receives: Other: food - dried fruit |
| no dried fruit | No intervention | no intervention to be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 24-hour urinary NAE
NAE reflects net acid-base balance
Measured: 12 month
Secondary outcomes (13)
rate of adherence with dried fruit
weight of dispensed fruit consumed, calculated as weight of fruit dispensed minus the weight of fruit returned
Measured: 12 months
change in 24-hour urinary N-telopeptide
a measure of bone resorption
Measured: 12 months
change in fat to lean tissue mass ratio
a measure of change in body composition by dual-energy x-ray absorptiometry (DXA:)
Measured: 12 months
change in bone mineral density at the total body
measured by DXA
Measured: 12 months
change in body weight
measured on a standard scale
Measured: 12 months
change in grip strength
hand grip strength in kilograms assessed by a hand held dynamometer
Measured: 12 months
Mediterranean diet score
a 14-item scale of adherence to a healthy Mediterranean style diet; a higher score represents a better diet
Measured: 12 months
change in bone mineral density of the spine
measured by DXA
Measured: 12 months
change in bone mineral density of the hip
measured by DXA
Measured: 12 months
Health Aging and Body Composition-leg strength
defined as ability to do 5 repeated chair stands; assessed on a 4-point scale; a higher score represents a better performance
Measured: 12 months
Health Aging and Body Composition - standing balance
defined as ability to stand in tandem position measured on a 4-point scale; a higher score represents a better performance
Measured: 12 months
Health Aging and Body Composition- gait speed
defined as usual gait speed of performing a 6-meter walk; assessed on a 4-point scale; a higher score represents a better performance
Measured: 12 months
Health Aging and Body Composition-physical performance battery
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start27 Aug 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: Institution shut down due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid-Base Balance DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Principal investigator, Bess Dawson-Hughes, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030351
- Sponsor's protocol ID
- 2980
- Status last verified
- Oct 2020
- First submitted
- 18 Jul 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dried Fruit Intake on Acid-base Balance in Community Dwelling Adults
- ClinicalTrials.gov ID
- NCT04030351
- Acronym / sponsor ID
- 2980
- Conditions
- Acid-Base Balance Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Institution shut down due to COVID-19
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dried fruit | Experimental | Other: food - dried fruit100 g per day of dried fruit |
| no dried fruit | No intervention | –no intervention to be given |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (29 listed)
- Conditions
- diabetes or fasting plasma glucose on screening >125 mg/dl
- untreated thyroid disease
- untreated parathyroid disease
- cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food - dried fruitraisins, apricots, figs, and pineapple | Other | dried fruit |
Primary outcome
change in 24-hour urinary NAE
Time frame: 12 month
NAE reflects net acid-base balance
13 secondary outcomes
rate of adherence with dried fruit
Time frame: 12 months
change in 24-hour urinary N-telopeptide
Time frame: 12 months
change in fat to lean tissue mass ratio
Time frame: 12 months
change in bone mineral density at the total body
Time frame: 12 months
change in body weight
Time frame: 12 months
change in grip strength
Time frame: 12 months
Mediterranean diet score
Time frame: 12 months
change in bone mineral density of the spine
Time frame: 12 months
change in bone mineral density of the hip
Time frame: 12 months
Health Aging and Body Composition-leg strength
Time frame: 12 months
Health Aging and Body Composition - standing balance
Time frame: 12 months
Health Aging and Body Composition- gait speed
Time frame: 12 months
Health Aging and Body Composition-physical performance battery
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Institution shut down due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food - dried fruit in people with Acid-Base Balance Disorder, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Institution shut down due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 24-hour urinary NAE (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.