Clinical Trials Directory

Trials / Completed

CompletedNCT00357214

Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults

Effect of Potassium Bicarbonate on Bone and Muscle

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

Summary

There is increasing evidence that the acid-base balance of diet plays an important role in the health of bones and muscles. An excess of acid in the body can result in calcium loss and muscle breakdown. Potassium bicarbonate, a base supplement, can neutralize acid within the body. The purpose of this study is to determine the effectiveness of potassium and bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older adults.

Detailed description

The typical American diet of dairy products, grains, and meats results in excess acid build-up in the body. The kidney is often unable to remove this excess acid quickly enough, resulting in mildly elevated blood acidity. In an attempt to neutralize the acidity, the body releases calcium from its bones. Over time, however, this calcium loss can lead to decreased bone density and possibly osteoporosis. Excess acid in the body also stimulates the breakdown of muscle. The combination of osteoporosis and reduced muscle strength sets the stage for falls, fractures, and ultimately functional decline. At least 30% of older adults fall once a year and, of those falls, 5% result in fractures. Preserving muscle mass and strength is an effective way to lower the risk of falling and to maintain independence among older people. Potassium bicarbonate is a base supplement that can neutralize acid. The purpose of this study is to determine the effectiveness of potassium and bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older adults. This study will last 3 months. Participants will be randomly assigned to one of four treatment groups: * Group 1 will receive potassium bicarbonate supplements * Group 2 will receive potassium chloride supplements * Group 3 will receive sodium bicarbonate supplements * Group 4 will receive placebo supplements All participants will take three pills of their assigned supplement after each meal; this will occur on a daily basis throughout the study. Participants will also take a multivitamin and a 600-mg calcium tablet daily. Participants will not be required to alter their usual diet in any way, but they will be requested to not take their usual calcium and vitamin D supplements during the study. Study visits will occur on Days 1, 21, 49, and 84. Days 1 and 84 study visits will include a review of medical history and physical activity, blood collection, and evaluation of weight, blood pressure, calcium absorption, and muscle function. Collection of both a 24-hour urine sample and a calendar depicting compliance with the supplement schedule will also occur at these two visits. The other study visits, on Days 21 and 49, may include blood collection, calendar compliance checking, and weight and blood pressure measurements. Supplements will be handed out on Days 1, 21, and 49.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPotassium Bicarbonate67.5 mmol/d given as three tablets after each meal, with a full glass of water
DIETARY_SUPPLEMENTSodium Bicarbonate67.5 mmol/d given as three tablets after each meal, with a full glass of water
DIETARY_SUPPLEMENTPotassium Chloride67.5 mmol/d given as three tablets after each meal, with a full glass of water
DIETARY_SUPPLEMENTplacebo (microcrystalline cellulose)Given as three tablets after each meal, with a full glass of water

Timeline

Start date
2006-09-01
Primary completion
2008-04-01
Completion
2008-04-01
First posted
2006-07-27
Last updated
2020-02-17
Results posted
2020-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00357214. Inclusion in this directory is not an endorsement.