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This study is determine the effects of dietary calcium and phytate on zinc absorption.
Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope, followed by retention monitoring in a whole body scintillation counter for 4 weeks. All four 4 experimental diets are tested with each subject, in randomized order, for a total of 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Study | Experimental | Participants consumed 4 experimental diets for 4 weeks each in randomized order |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Calcium, Low phytate Diet | Dietary Supplement | Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Zinc Absorption | Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet R Hunt | USDA Grand Forks Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Department of Agriculture Grand Forks Human Nutrition Research Center | Grand Forks | North Dakota | 58202 | United States |
205 participants applied, 157 were eligible, 27 accepted invitation to attend an information meeting, 10 started study, 7 of the alternates joined study as original participants withdrew or were discharged.
Women were recruited by the United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center to participate in an out-patient feeding study in Grand Forks, North Dakota
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium and Phytate Interactions | Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ca/Phytate Test Meal 1 (Randomized) |
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| Ca/Phytate Test Meal 2 (Randomized) |
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| Ca/Phytate Test Meal 3 (Randomized) |
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| Ca/Phytate Test Meal 4 (Randomized) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment |
| Units | Counts |
|---|---|
| Participants |
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| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Zinc Absorption | Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time | Analysis restricted to women who completed all 4 treatment periods | Posted | Mean | Standard Error | Percentage of Zinc-65 absorbed | 16 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 | Overall Study | Participants consumed 4 dietary treatments in randomized order |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda Ling | United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center | 701-795-8300 | brenda.ling@ars.usda.gov |
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| Moderate Calcium, High Phytate Diet | Dietary Supplement | Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks |
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| High Calcium, Low Phytate Diet | Dietary Supplement | Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks |
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| High Calcium, High Phytate Diet | Dietary Supplement | Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG002 | High Calcium, Low Phytate Diet | Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day |
| OG003 | High Calcium, High Phytate Diet | Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day |
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| 0 |
| 17 |
| 0 |
| 17 |
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