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

Osteoporosis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

• NCT number: NCT00730184
• Study type: Interventional
• Source: Tufts University
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Completion date: December 2007