HealthyNCT00620763
Calcium Retention as Influenced by Dietary Components That Induce an Acid Load
A study testing High Meat - High Potential Renal Acid Load (PRAL) diet and Low Protein - Low Potential Renal Acid Load (PRAL) diet in people with Healthy, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High Meat - High Potential Renal Acid Load (PRAL) diet and Low Protein - Low Potential Renal Acid Load (PRAL) diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Average body mass index
- Normal blood work
- Normal bone density
Who cannot join
- Chronic disorder
- Non-traumatic bone fractures
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202
About this study
Official title: Calcium Retention in Postmenopausal Women as Influenced by Beef and Other Dietary Components That Induce an Acid Load
The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy postmenopausal women recruited from the community will consume two diets differing in meat protein and acid load for 7 weeks. Calcium retention from diets will be determined using a highly sensitive measurement of whole body retention of a calcium isotope added to the diet.
- Conditions
- Healthy
- Being tested
- High Meat - High Potential Renal Acid Load (PRAL) diet, Low Protein - Low Potential Renal Acid Load (PRAL) diet
- Keywords
- Meat protein, acid load, calcium retention, postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Meat - High Potential Renal Acid Load (PRAL) dietOther
Menu high in meat protein
Low Protein - Low Potential Renal Acid Load (PRAL) dietOther
Menu low in meat protein
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dietary Intervention: High meat and high acid load diet followed by low meat and low acid load diet Receives: Other: High Meat - High Potential Renal Acid Load (PRAL) diet; Other: Low Protein - Low Potential Renal Acid Load (PRAL) diet |
| B | Experimental | Dietary Intervention: Low meat and low acid load diet followed by high meat and high acid load diet Receives: Other: High Meat - High Potential Renal Acid Load (PRAL) diet; Other: Low Protein - Low Potential Renal Acid Load (PRAL) diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Absorption
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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jay Cao, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620763
- Sponsor's protocol ID
- GFHNRC087
- Other IDs
- IRB-2000707-013
- Status last verified
- May 2018
- First submitted
- 18 Jan 2008
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Roughead ZK, Johnson LK, Lykken GI, Hunt JR. Controlled high meat diets do not affect calcium retention or indices of bone status in healthy postmenopausal women. J Nutr. 2003 Apr;133(4):1020-6. doi: 10.1093/jn/133.4.1020.
PubMed 12672913Cao JJ, Johnson LK, Hunt JR. A diet high in meat protein and potential renal acid load increases fractional calcium absorption and urinary calcium excretion without affecting markers of bone resorption or formation in postmenopausal women. J Nutr. 2011 Mar;141(3):391-7. doi: 10.3945/jn.110.129361. Epub 2011 Jan 19.
PubMed 21248199
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Retention in Postmenopausal Women as Influenced by Beef and Other Dietary Components That Induce an Acid Load
- ClinicalTrials.gov ID
- NCT00620763
- Acronym / sponsor ID
- GFHNRC087
- Conditions
- Healthy
- Keywords
- Meat protein, acid load, calcium retention, postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy postmenopausal women recruited from the community will consume two diets differing in meat protein and acid load for 7 weeks. Calcium retention from diets will be determined using a highly sensitive measurement of whole body retention of a calcium isotope added to the diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: High Meat - High Potential Renal Acid Load (PRAL) diet, Other: Low Protein - Low Potential Renal Acid Load (PRAL) dietDietary Intervention: High meat and high acid load diet followed by low meat and low acid load diet |
| B | Experimental | Other: High Meat - High Potential Renal Acid Load (PRAL) diet, Other: Low Protein - Low Potential Renal Acid Load (PRAL) dietDietary Intervention: Low meat and low acid load diet followed by high meat and high acid load diet |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Average body mass index
- Normal blood work
- Normal bone density
Key exclusion criteria (2 listed)
- Chronic disorder
- Non-traumatic bone fractures
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 Meat - High Potential Renal Acid Load (PRAL) dietMenu high in meat protein | Other | A, B |
| Low Protein - Low Potential Renal Acid Load (PRAL) dietMenu low in meat protein | Other | A, B |
Primary outcome
Calcium Absorption
Time frame: 18 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12672913Roughead ZK, Johnson LK, Lykken GI, Hunt JR. Controlled high meat diets do not affect calcium retention or indices of bone status in healthy postmenopausal women. J Nutr. 2003 Apr;133(4):1020-6. doi: 10.1093/jn/133.4.1020.
- Derived from this study: PubMed 21248199Cao JJ, Johnson LK, Hunt JR. A diet high in meat protein and potential renal acid load increases fractional calcium absorption and urinary calcium excretion without affecting markers of bone resorption or formation in postmenopausal women. J Nutr. 2011 Mar;141(3):391-7. doi: 10.3945/jn.110.129361. Epub 2011 Jan 19.
- Related InfoLink provided by the sponsor.
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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.
Jay Cao, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
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 Meat - High Potential Renal Acid Load (PRAL) diet and Low Protein - Low Potential Renal Acid Load (PRAL) diet in people with Healthy, run by USDA Grand Forks Human Nutrition Research Center 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calcium Absorption (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00620763, which also lists 2 linked publications.
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 2 Jul 2018.