Clinical Trials Directory

Trials / Completed

CompletedNCT00730184

Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Tufts University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTpotassium bicarbonate90 mmol/d given as 4 tablets after each meal, with a full glass of water
DIETARY_SUPPLEMENTPlacebo (microcrystalline cellulose)Given as 4 tablets after each meal, with a full glass of water

Timeline

Start date
2007-02-01
Primary completion
2007-11-01
Completion
2007-12-01
First posted
2008-08-08
Last updated
2008-08-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00730184. Inclusion in this directory is not an endorsement.