Status:

COMPLETED

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

Lead Sponsor:

Tufts University

Collaborating Sponsors:

Baylor College of Medicine

Conditions:

Osteoporosis

Sarcopenia

Eligibility:

All Genders

50+ years

Phase:

NA

Brief 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 ...

Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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)

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT00730184

Start Date

February 1 2007

End Date

December 1 2007

Last Update

August 8 2008

Active Locations (1)

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1

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States, 02111

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