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Trial Outcomes & Findings for Calcium Retention as Influenced by Dietary Components That Induce an Acid Load (NCT NCT00620763)

NCT ID: NCT00620763

Last Updated: 2018-07-02

Results Overview

After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

18 weeks

Results posted on

2018-07-02

Participant Flow

Participants were recruited from the Grand Forks, North Dakota community in November and December, 2007.

Of the 128 women who applied for the study, 56 did not meet the criteria, 46 declined, 4 were alternates, and 22 joined the study.

Participant milestones

Participant milestones
Measure
High Meat & High Potential Renal Acid Load - First
High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
Low Meat & Low Potential Renal Acid Load - First
Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
Period: First Intervention
STARTED
10
12
Period: First Intervention
COMPLETED
10
7
Period: First Intervention
NOT COMPLETED
0
5
Period: Washout Period of 1 Week
STARTED
10
7
Period: Washout Period of 1 Week
COMPLETED
10
7
Period: Washout Period of 1 Week
NOT COMPLETED
0
0
Period: Second Intervention
STARTED
10
7
Period: Second Intervention
COMPLETED
9
7
Period: Second Intervention
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
High Meat & High Potential Renal Acid Load - First
High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
Low Meat & Low Potential Renal Acid Load - First
Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
Period: First Intervention
Withdrawal by Subject
0
2
Period: First Intervention
Protocol Violation
0
3
Period: Second Intervention
Withdrawal by Subject
1
0

Baseline Characteristics

Calcium Retention as Influenced by Dietary Components That Induce an Acid Load

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=22 Participants
Dietary Intervention: Crossover design, High meat and high potential renal acid load (high PRAL) diet and low meat and low potential renal acid load (low PRAL) diet, consumed in random order.
Age, Continuous
56.9 years
STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks

Population: Analysis included only the 16 volunteers that completed both dietary interventions.

After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.

Outcome measures

Outcome measures
Measure
High Meat - High Potential Renal Acid Load
n=16 Participants
High meat and high potential renal acid load (high PRAL) diet in either the first or second intervention period
Low Meat - Low Potential Renal Acid Load
n=16 Participants
Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period
Calcium Absorption
30.4 percentage of Calcium-47 absorbed
Standard Error 2.4
25.4 percentage of Calcium-47 absorbed
Standard Error 2.4

Adverse Events

High Meat & High Potential Renal Acid Load - First

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Low Meat & Low Potential Renal Acid Load - First

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brenda Ling

United States Department of Agriculture Grand Forks Human Nutrition Research Center

Phone: 701-795-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place