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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Potassium Bicarbonate on Bone and Muscle

Conditions
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Osteoporosis, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Potassium Bicarbonate
* Dietary Supplement: Sodium Bicarbonate
* Dietary Supplement: Potassium Chloride
* Dietary Supplement: placebo (microcrystalline cellulose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass idex less than 35 Not currently on a weight gain or weight loss diet Willing to maintain usual level of physical activity Willing to refrain from taking own calcium supplements, antacids, or salt substitutes Exclusion Criteria: Vegetarian Use of glucocorticoids for more than 10 days in the 3 months prior to study entry Use of estrogen, raloxifene, or calcitonin in the 6 months prior to study entry Use of bisphosphonate or teriparatide in the 2 years prior to study entry Current use of diuretics, nonsteroidal anti-inflammatory drugs (NSAIDS), beta-blockers, anabolic drugs (steroids or other), angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs) Renal disease, including kidney stones in the 5 years prior to study entry or creatinine clearance less than 50 ml/min/1.73 m2 of body surface area Hyperparathyroidism Untreated thyroid disease Significant immune disorder Current unstable heart disease Active malignancy or cancer therapy in the year prior to study entry 24-hour urine calcium levels greater than 300 mg/d after 1 week of being off calcium supplements Hypertension, congestive heart failure, arrythmias, or myocardial infarction in the 12 months prior to study entry On a salt-restricted diet Bone density total hip T score of less than -2.5 Abnormal serum calcium Alkaline phosphatase levels greater than 10% above the upper end of the reference range Adrenal insufficiency, primary aldosteronism, or Bartter's syndrome Diabetes mellitus Alcohol use exceeding two drinks/day Peptic ulcers or esophageal stricture Screening serum 25(OH)D levels below 16 ng/ml

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: potassium bicarbonate<br>Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. | Dietary Supplement: Potassium Bicarbonate<br>* 67.5 mmol/d given as three tablets after each meal, with a full glass of water<br>|
| Active Comparator: Sodium bicarbonate<br>Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. | Dietary Supplement: Sodium Bicarbonate<br>* 67.5 mmol/d given as three tablets after each meal, with a full glass of water<br>|
| Active Comparator: Potassium chloride<br>Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. | Dietary Supplement: Potassium Chloride<br>* 67.5 mmol/d given as three tablets after each meal, with a full glass of water<br>|
| Placebo Comparator: microcrystalline cellulose<br>Participants will receive placebo is microcrystalline cellulose. This compound has no other name. | Dietary Supplement: placebo (microcrystalline cellulose)<br>* Given as three tablets after each meal, with a full glass of water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Markers of Bone Turnover | Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months | 3 month change in 24-hr urine values | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone turnover, calcium excretion, nitrogen excretion, potassium bicarbonate, muscle loss, muscle atrophy, bone loss