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

NCT00730184 | Completed

• 2 other identifiers: 25107937
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Sarcopenia

Keywords

acid-base; potassium; acidosis; osteoporosis; sarcopenia; calcium absorption; dietary protein

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: potassium bicarbonate

2

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (microcrystalline cellulose)

Interventions

potassium bicarbonate DIETARY_SUPPLEMENT

90 mmol/d given as 4 tablets after each meal, with a full glass of water

1

Placebo (microcrystalline cellulose) DIETARY_SUPPLEMENT

Given as 4 tablets after each meal, with a full glass of water

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• hr urine calcium \> 300 mg/d after 1 wk off of calcium supplements

Sponsors & Collaborators

• Tufts University: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 19856249 DERIVED

MeSH Terms

Conditions

Osteoporosis; Sarcopenia; Acidosis

Interventions

potassium bicarbonate; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acid-Base Imbalance

Study Officials

• Bess Dawson-Hughes, MD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Lisa Ceglia, MD

  Tufts University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 8, 2008

Record last verified: 2008-08

Locations

US (1)