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

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoporosis, Sarcopenia

In brief

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.

Key facts

Study ID

NCT00730184

Run by

Tufts University

People needed

23

Starts

2007-02-01

Expected to finish

2007-12-01

Last updated by the study team

2008-08-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• This study will be conducted in subjects with body mass index < 38 kg/m2.
• Women must be at least 6 months since last menses.
• Subjects must be willing to maintain their usual exercise level and agree not to attempt to gain or lose weight or change their diets substantially during the study.
• Subjects will not be allowed to take their own calcium or vitamin D supplements from one week before their screening visit through the end of the study.
• They must also agree not to ingest bicarbonate- or potassium-rich products such as selected antacids and salt substitutes during the study.
• They must also agree not to consume alcohol during the study.

You may not qualify if…

• Medications
• Oral glucocorticoid use for > 10 days in the last 3 months
• Estrogen, raloxifene, or calcitonin use in the last 6 months, bisphosphonate or teriparatide use in the last 2 years
• Current use of diuretics
• Regular use of NSAIDS (> 3 times per wk) or anabolic drugs (steroids or other). Note that subjects may use acetominophen for joint or other discomforts during the study.
• Conditions/Diseases
• Renal disease including kidney stones in the past 5 years or creatinine clearance < 50 ml/min/1.73 X m2 of body surface area
• Cirrhosis
• GERD requiring treatment with alkali-containing antacids (use of Lowsium okay)
• Hyperparathyroidism
• Untreated thyroid disease
• Significant immune disorder such as rheumatoid arthritis, SLE
• Current unstable heart disease
• Active malignancy or cancer therapy in the last year
• 24-hr urine calcium > 300 mg/d after 1 wk off of calcium supplements
• Subjects with arrythmias (surgically treated arrythmias acceptable), or myocardial infarction in last 12 months
• Total hip T score of < -3.0
• Abnormal serum calcium; alkaline phosphatase >10% above the upper end of the reference range
• Adrenal insufficiency, primary aldosteronism, Bartter's syndrome
• Diabetes mellitus (fasting blood sugar > 130)
• Alcohol use exceeding 2 drinks/day
• Peptic ulcers or esophageal stricture
• Screening serum 25(OH)D levels below 16 ng/ml
• Vegetarians
• Other abnormalities in screening labs, at discretion of the study physician (principal investigator)

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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