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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730184
• Other study ID #: 2510
• Secondary ID: 7937
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: August 7, 2008
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Dietary Supplement:
• potassium bicarbonate
90 mmol/d given as 4 tablets after each meal, with a full glass of water
• Placebo (microcrystalline cellulose)
Given as 4 tablets after each meal, with a full glass of water

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women.		before and after low and high protein diet cycles	No
Primary	To determine the impact of administration of an alkalinizing salt on urinary calcium excretion in the same population.		before and after low and high protein diet cycle	No
Secondary	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.		before and after low and high protein diet cycles	No
Secondary	To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on calcium absorption in the same population.		before and after low and high protein diet cycles	No
Secondary	To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on serum IGF-1 in the same population.		before and after low and high protein diet cycles	No