Dietary ProteinsNCT00700804
Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
A study testing High Protein Diet and Low Protein Diet in people with Dietary Proteins, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Proteins
- What is being tested?
- High Protein Diet and Low Protein Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jan 2005
- 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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 3 years since last menses
- bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
- body mass index equal to or less than 35 kilograms/meter squared
Who cannot join
- taking prescription medication other than hormone replacement therapy
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
The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.
Read the detailed description
This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.
- Conditions
- Dietary Proteins
- Being tested
- High Protein Diet, Low Protein Diet
- Keywords
- Calcium retention, dietary protein, dietary calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein DietBehavioural
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
Low Protein DietBehavioural
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
| Study group | Role | What they receive |
|---|---|---|
| High Calcium Diet | Experimental | Not described Receives: Behavioral: High Protein Diet |
| Low Calcium Diet | Experimental | Not described Receives: Behavioral: Low Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Absorption
Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time
Measured: 17 weeks
Secondary outcomes (1)
Serum Insulin-like Growth Factor 1 (IGF-1)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2003
- Primary completionJul 2004
- Study completionJan 2005
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.
- Other trials for Dietary ProteinsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
- Investigators
- Janet R Hunt, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700804
- Sponsor's protocol ID
- GFHNRC064
- Other IDs
- IRB-200307-010
- Status last verified
- May 2018
- First submitted
- 18 Jun 2008
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
- ClinicalTrials.gov ID
- NCT00700804
- Acronym / sponsor ID
- GFHNRC064
- Conditions
- Dietary Proteins
- Keywords
- Calcium retention, dietary protein, dietary calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- Jun 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 2 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.
Detailed description
This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Calcium Diet | Experimental | Behavioral: High Protein Diet |
| Low Calcium Diet | Experimental | Behavioral: Low Protein Diet |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 3 years since last menses
- bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
- body mass index equal to or less than 35 kilograms/meter squared
Key exclusion criteria (1 listed)
- taking prescription medication other than hormone replacement therapy
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 Protein DietHigh and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm | Behavioural | High Calcium Diet |
| Low Protein DietHigh and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm | Behavioural | Low Calcium Diet |
Primary outcome
Calcium Absorption
Time frame: 17 weeks
Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time
1 secondary outcome
Serum Insulin-like Growth Factor 1 (IGF-1)
Time frame: 7 weeks
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.
Related trials for Dietary Proteins
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Not yet recruiting
Dietary Supplementation and Hydration
Hydration
Recruiting
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
Obesity & Overweight, Muscle Mass and Strength
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
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.
Janet R Hunt, 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 Protein Diet and Low Protein Diet in people with Dietary Proteins, 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 1 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 2 Jun 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: 17 weeks). 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 2 Jul 2018.