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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-2000707-013 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Dietary Intervention: High meat and high acid load diet followed by low meat and low acid load diet |
|
| B | Experimental | Dietary Intervention: Low meat and low acid load diet followed by high meat and high acid load diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Meat - High Potential Renal Acid Load (PRAL) diet | Other | Menu high in meat protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Cao, PhD | USDA Grand Forks Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center | Grand Forks | North Dakota | 58202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12672913 | Background | 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. | |
| 21248199 | Derived | Cao 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. |
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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.
Participants were recruited from the Grand Forks, North Dakota community in November and December, 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period: First Intervention |
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| |||||||||||||||||||||
| Period: Washout Period of 1 Week |
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| Period: Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis included only the 16 volunteers that completed both dietary interventions. | Posted | Mean | Standard Error | percentage of Calcium-47 absorbed | 18 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda Ling | United States Department of Agriculture Grand Forks Human Nutrition Research Center | 701-795-8300 | brenda.ling@ars.usda.gov |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Low Protein - Low Potential Renal Acid Load (PRAL) diet | Other | Menu low in meat protein |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 19 | 0 | 19 |
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