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

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00730184
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Osteoporosis
Sarcopenia
Dietary Supplement: potassium bicarbonate
Dietary Supplement: Placebo (microcrystalline cellulose)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women. [ Time Frame: before and after low and high protein diet cycles ] [ Designated as safety issue: No ]
  • To determine the impact of administration of an alkalinizing salt on urinary calcium excretion in the same population. [ Time Frame: before and after low and high protein diet cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on biochemical markers of bone turnover in the same population. [ Time Frame: before and after low and high protein diet cycles ] [ Designated as safety issue: No ]
  • To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on calcium absorption in the same population. [ Time Frame: before and after low and high protein diet cycles ] [ Designated as safety issue: No ]
  • To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on serum IGF-1 in the same population. [ Time Frame: before and after low and high protein diet cycles ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants receive potassium bicarbonate in dosage of 90 mmol/d. This compound has no other name.
Dietary Supplement: potassium bicarbonate
90 mmol/d given as 4 tablets after each meal, with a full glass of water
Placebo Comparator: 2
Participants receive placebo as microcrystalline cellulose. This compound has no other name.
Dietary Supplement: Placebo (microcrystalline cellulose)
Given as 4 tablets after each meal, with a full glass of water

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 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730184

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Baylor College of Medicine
Investigators
Principal Investigator: Bess Dawson-Hughes, MD Tufts University
Study Director: Lisa Ceglia, MD Tufts University
  More Information

No publications provided by Tufts University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bess Dawson-Hughes, MD, Tufts University
ClinicalTrials.gov Identifier: NCT00730184     History of Changes
Other Study ID Numbers: 2510, 7937
Study First Received: August 5, 2008
Last Updated: August 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
acid-base
potassium
acidosis
osteoporosis
sarcopenia
calcium absorption
dietary protein

Additional relevant MeSH terms:
Osteoporosis
Sarcopenia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014