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| ID | Type | Description | Link |
|---|---|---|---|
| 7937 |
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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
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The purpose of this study is to examine whether adding the basic salt potassium bicarbonate to the diet will have a positive effect on how dietary protein affects your bone and muscle.
The balance between the amount of protein in the diet (anabolic component) and the net acid load of the diet (catabolic component) in part determines whether the diet as a whole has a net anabolic or catabolic effect on bone and muscle. This study will investigate whether the addition of an alkaline salt of potassium, potassium bicarbonate, will allow dietary protein to have a more favorable net impact on intermediary indices of bone and muscle conservation than is observed with protein in the usual acidic environment.
Men and postmenopausal women, age 50 and older, will be enrolled in this 42-day study in order to have 20 completers. Subjects may continue in the study for up to an additional two weeks should this be necessary for reasons related to intercurrent illness (unrelated to the research) or scheduling circumstances. Over the first 15 days, subjects will be placed on gradually increasing doses, up to a maximum of 90 mmol/d of potassium bicarbonate or placebo. They will remain on this dose for the rest of the study. Subjects will then have two 10-day metabolic diet cycles each, in random order, as follows:
Group 1 - low protein diet (0.5 g/kg/d) then high protein diet (1.5 g/kg/d) Group 2 - high protein diet (1.5 g/kg/d) then low protein diet (0.5 g/kg/d)
There will be a 5-day period between the two metabolic diets in which subjects consume their usual diets but continue to take the study pills.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Participants receive potassium bicarbonate in dosage of 90 mmol/d. This compound has no other name. |
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| 2 | Placebo Comparator | Participants receive placebo as microcrystalline cellulose. This compound has no other name. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| potassium bicarbonate | Dietary Supplement | 90 mmol/d given as 4 tablets after each meal, with a full glass of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women. | before and after low and high protein diet cycles | |
| To determine the impact of administration of an alkalinizing salt on urinary calcium excretion in the same population. | before and after low and high protein diet cycle |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on biochemical markers of bone turnover in the same population. | before and after low and high protein diet cycles | |
| To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on calcium absorption in the same population. |
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Inclusion Criteria:
Exclusion Criteria:
Medications
Conditions/Diseases
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| Name | Affiliation | Role |
|---|---|---|
| Bess Dawson-Hughes, MD | Tufts University | Principal Investigator |
| Lisa Ceglia, MD | Tufts University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19856249 | Derived | Ceglia L, Abrams SA, Harris SS, Rasmussen HM, Dallal GE, Dawson-Hughes B. A simple single serum method to measure fractional calcium absorption using dual stable isotopes. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):653-6. doi: 10.1055/s-0029-1234088. Epub 2009 Oct 23. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D055948 | Sarcopenia |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C026329 | potassium bicarbonate |
| C109691 | microcrystalline cellulose |
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| Placebo (microcrystalline cellulose) | Dietary Supplement | Given as 4 tablets after each meal, with a full glass of water |
|
| before and after low and high protein diet cycles |
| To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on serum IGF-1 in the same population. | before and after low and high protein diet cycles |
| D009750 |
| Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D000137 | Acid-Base Imbalance |