Urine pH and Diet Net Acid Load | NCT02116595

Studies
Urine pH and Diet Net Acid Load

NCT02116595

Sponsor

University of California, San Francisco

Status

Withdrawn

Last Update Posted

Jul 27, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

high or low acid diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not funded

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2017

Last Update Posted Date

Jul 27, 2017Actual

Name	Class
optimal wellness labs	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
feeding a high acid diet x 24 hrs	Experimental	2 diets, one low and one high net acid loads	Other: high or low acid diet
low acid diet	Active Comparator		Other: high or low acid diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high or low acid diet	Other	high or low acid diets	feeding a high acid diet x 24 hrs low acid diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
high acid diet	correlation between first morning urine pH and 24 hour net acid excretion	6 months
low acid diet	correlation between first morning urine pH and 24 hour net acid excretion	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no medical or psychological problems
able to come to UCSF for study

Exclusion Criteria:

pregnant or trying to become pregnant
Hg < 10
abnormal screening labs
anyone unable to follow study directions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
lynda frassetto, md	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF		San Francisco	California	94143	United States