HealthyNCT02116595
Urine pH and Diet Net Acid Load
A study testing high or low acid diet in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
Presently, the gold standard for testing diet acid intake is a urine collection done for many hours, usually 24 hours, which must be analyzed in a research lab for "net acid excretion". So, getting information about diet acid intake is difficult. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- high or low acid diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no medical or psychological problems
- able to come to UCSF for study
Who cannot join
- pregnant or trying to become pregnant
- Hg < 10
- abnormal screening labs
- anyone unable to follow study directions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alterations in Urine pH With Differing Diet Net Acid Loads
Presently, the gold standard for testing diet acid intake is a urine collection done for many hours, usually 24 hours, which must be analyzed in a research lab for "net acid excretion". So, getting information about diet acid intake is difficult. Many people have suggested doing a much simpler test, which is checking the pH of the urine when you wake up. But, no one has studied if this simpler method is a valid method for estimating the 24 hour net acid excretion. Diet acid load may be important in many diseases associated with aging, such as loss of bone and muscle, and the development of kidney disease.
Read the detailed description
the primary outcome variable is morning urine pH and 24 hour urine net acid excretion
- Conditions
- Healthy
- Being tested
- high or low acid diet
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high or low acid dietOther
high or low acid diets
| Study group | Role | What they receive |
|---|---|---|
| feeding a high acid diet x 24 hrs | Experimental | 2 diets, one low and one high net acid loads Receives: Other: high or low acid diet |
| low acid diet | Active comparator | Not described Receives: Other: high or low acid diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
high acid diet
correlation between first morning urine pH and 24 hour net acid excretion
Measured: 6 months
low acid diet
correlation between first morning urine pH and 24 hour net acid excretion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionMay 2016
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- optimal wellness labs
- Responsible party
- Sponsor
- Investigators
- lynda frassetto, md, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116595
- Sponsor's protocol ID
- UPH&DNAE
- Status last verified
- Jul 2017
- First submitted
- 15 Apr 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Urine pH With Differing Diet Net Acid Loads
- ClinicalTrials.gov ID
- NCT02116595
- Acronym / sponsor ID
- UPH&DNAE
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- optimal wellness labs
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Apr 2014 (estimated)
- 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.
Presently, the gold standard for testing diet acid intake is a urine collection done for many hours, usually 24 hours, which must be analyzed in a research lab for "net acid excretion". So, getting information about diet acid intake is difficult. Many people have suggested doing a much simpler test, which is checking the pH of the urine when you wake up. But, no one has studied if this simpler method is a valid method for estimating the 24 hour net acid excretion. Diet acid load may be important in many diseases associated with aging, such as loss of bone and muscle, and the development of kidney disease.
Detailed description
the primary outcome variable is morning urine pH and 24 hour urine net acid excretion
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| feeding a high acid diet x 24 hrs | Experimental | Other: high or low acid diet2 diets, one low and one high net acid loads |
| low acid diet | Active comparator | Other: high or low acid diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no medical or psychological problems
- able to come to UCSF for study
Key exclusion criteria (4 listed)
- pregnant or trying to become pregnant
- Hg < 10
- abnormal screening labs
- anyone unable to follow study directions
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 |
|---|---|---|
| high or low acid diethigh or low acid diets | Other | feeding a high acid diet x 24 hrs, low acid diet |
Primary outcome
high acid diet
Time frame: 6 months
correlation between first morning urine pH and 24 hour net acid excretion
low acid diet
Time frame: 6 months
correlation between first morning urine pH and 24 hour net acid excretion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
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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.
lynda frassetto, md principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high or low acid diet in people with Healthy, run by University of California, San Francisco 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Jul 2017. 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 withdrawn before enrolling participants, so there are no results.
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?
high acid diet (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Jul 2017.