search
Back to results

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

Primary Purpose

Osteoporosis, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
potassium bicarbonate
Placebo (microcrystalline cellulose)
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring acid-base, potassium, acidosis, osteoporosis, sarcopenia, calcium absorption, dietary protein

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Participants receive potassium bicarbonate in dosage of 90 mmol/d. This compound has no other name.

Participants receive placebo as microcrystalline cellulose. This compound has no other name.

Outcomes

Primary Outcome Measures

To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women.
To determine the impact of administration of an alkalinizing salt on urinary calcium excretion in the same population.

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.
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on calcium absorption in the same population.
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on serum IGF-1 in the same population.

Full Information

First Posted
August 5, 2008
Last Updated
August 7, 2008
Sponsor
Tufts University
Collaborators
Baylor College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00730184
Brief Title
Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?
Official Title
Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tufts University
Collaborators
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Sarcopenia
Keywords
acid-base, potassium, acidosis, osteoporosis, sarcopenia, calcium absorption, dietary protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants receive potassium bicarbonate in dosage of 90 mmol/d. This compound has no other name.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo as microcrystalline cellulose. This compound has no other name.
Intervention Type
Dietary Supplement
Intervention Name(s)
potassium bicarbonate
Intervention Description
90 mmol/d given as 4 tablets after each meal, with a full glass of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (microcrystalline cellulose)
Intervention Description
Given as 4 tablets after each meal, with a full glass of water
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bess Dawson-Hughes, MD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Ceglia, MD
Organizational Affiliation
Tufts University
Official's Role
Study Director
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19856249
Citation
Ceglia L, Abrams SA, Harris SS, Rasmussen HM, Dallal GE, Dawson-Hughes B. A simple single serum method to measure fractional calcium absorption using dual stable isotopes. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):653-6. doi: 10.1055/s-0029-1234088. Epub 2009 Oct 23.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs