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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-200307-010 |
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| Name | Class |
|---|---|
| National Cattlemen's Beef Association, a contractor to the Beef Checkoff | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Calcium Diet | Experimental |
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| Low Calcium Diet | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Protein Diet | Behavioral | High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Insulin-like Growth Factor 1 (IGF-1) | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet R Hunt, 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 |
Subjects were assigned to either the High or Low Calcium diets. The subjects then consumed the high and low protein diets in random order, i.e. half of the subjects consumed high protein, then low protein while the other half consumed low protein, then the high protein diet. Drop-outs were replaced.
Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks
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| ID | Title | Description |
|---|---|---|
| FG000 | High Calcium Diet | Women consumed diets containing 1500 milligrams of calcium daily |
| FG001 | Low Calcium Diet | Women consumed diets containing 600 milligrams of calcium daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Calcium Diet | Women consumed diets containing 1500 milligrams of calcium daily |
| BG001 | Low Calcium Diet | Women consumed diets containing 600 milligrams of calcium daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Serum Insulin-like Growth Factor 1 (IGF-1) | Posted | Geometric Mean | Standard Error | nanomoles per liter (nmols/L) | 7 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 Calcium Diet | Women consumed diets containing 1500 milligrams of calcium daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Hunt, PhD | United States Department of Agriculture (USDA) Grand Forks Human Nutrition Reserch Center | 701-795-8353 | janetrhunt@gmail.com |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low Protein Diet | Behavioral | High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm |
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| Loose Stools |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | 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 | Only participants which completed both protein diet periods were included in the statistical analysis | Posted | Mean | Standard Deviation | percentage of Calcium absorbed | 17 weeks |
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| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Low Calcium Diet | Women consumed diets containing 600 milligrams of calcium daily | 0 | 17 | 0 | 17 |
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |