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Completed

NCT Number: NCT02691663

Dietary Acid Load, Kidney Function and Disability in Elderly

The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

Physical decline and frailty result from age- and disease-related impairments in organs and tissues. Frailty research has focused on the musculoskeletal, neurological and circulatory systems; yet interventions targeting these systems had limited success in preventing and treating functional decline. Given the aging of the US population, additional avenues for intervention development are urgently needed. Fragility and disability in people ≥65 strongly correlate with declining kidney function and are evident even in early stages of chronic kidney disease (CKD). Moreover, CKD is highly prevalent in the elderly and associates with sarcopenia, osteopenia, and increased incidence of fractures/falls with hospitalization. Low serum bicarbonate and impaired acid-base homeostasis, also common in CKD, are increasingly appreciated as contributors to functional decline with advancing age. With aging, the adaptive response of the kidney to low serum bicarbonate and high metabolic acid load becomes maladaptive, facilitating CKD progression. Conversely, in adult patients with CKD, maintenance of serum bicarbonate at 24 meq/L with oral bicarbonate supplementation or increased consumption of base-forming foods slows CKD progression.

The study investigators propose the current study and protocol based on the evidence summarized above and our preliminary studies, which suggest that: In the Health Aging and Body Composition cohort (age 70-79) lower dietary acid load associates with stable kidney function over a 7-year follow-up, independent of age, race, gender, BMI, diabetes, hypertension or smoking status; metabolomics analysis in participants of the African American Diabetes Heart Study suggested that it is feasible to segregate a urine metabolomics profile in the early stages of CKD (stages 2 and 3), and that lower consumption of base-forming fruits and vegetables and higher rates of acid excretion may be associated with CKD and its progression.

The investigators therefore hypothesized that decreasing metabolic acid production by titrating dietary acid load may ameliorate the generally expected, age-related decline in kidney function, decrease loss of lean body mass, preserve physical function, and ameliorate disability. This is not a treatment study as the investigators are exploring the effects of bicarbonate on these age-related issues.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 +years of age
  • Short physical performance battery (SPPB) score>3
  • Estimated glomerular filtration rate (eGFR) 30-89
  • Net endogenous acid production (NEAP) >=40 mEq/d
  • Willing to provide informed consent and agrees to randomization
  • Not involved in another intervention study

Exclusion criteria

  • Uncontrolled (>160 mg/dl fasting blood glucose), insulin-dependent diabetes and/or uncontrolled hypertension (Systolic Blood Pressure >160, Diastolic BP>100)
  • a current diagnosis of psychotic disorder
  • take more than 14 alcoholic drinks per week
  • plan to relocate out of the study area within the next year
  • self-reported inability to walk across a room
  • those who reside in nursing homes
  • have difficulty communicating with study personnel due to speech or language or hearing problems
  • had cancer requiring treatment in the past 1 year
  • lung disease requiring regular use of corticosteroids or of supplemental oxygen
  • cardiovascular disease (Class III or IV congestive heart failure)
  • significant valvular disease, uncontrolled angina
  • myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery) in past 6 months
  • stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months, Parkinson's disease or other progressive neurological disorder
  • other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention
  • clinical judgment concerning safety or noncompliance
  • Individuals with BMI <18.5; or weight loss >4% in last 6 months
  • Montreal Cognitive Assessment (MoCA) score under 24
  • End Stage Renal Disease (ESRD) on dialysis or primary kidney disease
  • Other illness of such severity that life expectancy is less than 12 months
  • Smoking; defined as not smoking for more than a year prior to the study
  • Serum Bicarbonate (HCO3)>30 milliequivalents per liter (mEq/L); serum potassium out of normal range

Treatment and study plan

Oral bicarbonate supplementation

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Blood Bicarbonate

    Time frame: baseline

    measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults

  2. Blood Bicarbonate

    Time frame: six months post baseline

    measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults

Secondary outcomes

  1. Percentage of Screened Participants Randomized

    Time frame: baseline

    The number of participants randomized divided by the number of participants screened. Count of participants reflects the number of participants randomized.

  2. Percent Adherence: Percentage of Pills Taken

    Time frame: 6 months post baseline

    based on pill count

  3. Carbon Dioxide Blood Test

    Time frame: baseline

    Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)

  4. Carbon Dioxide Blood Test

    Time frame: six months post baseline

    Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)

  5. 400 Meter Walk Time

    Time frame: baseline

  6. 400 Meter Walk Time

    Time frame: three months post baseline

  7. 400 Meter Walk Time

    Time frame: six months post baseline

  8. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: baseline

    a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age

  9. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: three months post baseline

    a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age

  10. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: six months post baseline

    a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age

  11. Measurement of Kidney Function (eGFR) at Baseline.

    Time frame: baseline

    a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age

  12. Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline

    Time frame: six months post baseline

    a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age

  13. Hip Bone Mineral Density

    Time frame: baseline

    Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.

  14. Hip Bone Mineral Density

    Time frame: six months post baseline

    Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.

  15. Femoral Neck Bone Mineral Density

    Time frame: baseline

    Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.

  16. Femoral Neck Bone Mineral Density

    Time frame: six months post baseline

    Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.

  17. Average Body Mass Index (BMI)

    Time frame: baseline

  18. Average Body Mass Index (BMI)

    Time frame: three months post baseline

  19. Average Body Mass Index (BMI)

    Time frame: six months post baseline

  20. Urinary Albumin to Creatinine Ratio (ACR)

    Time frame: baseline

    The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.

  21. Urinary Albumin to Creatinine Ratio (ACR)

    Time frame: three months post baseline

    The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.

  22. Urinary Albumin to Creatinine Ratio (ACR)

    Time frame: six months post baseline

    The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.

Other outcomes

  1. Net Endogenous Acid Production (NEAP)

    Time frame: 6 months post randomization

    (mEq/day) by the kidney

  2. Net Endogenous Acid Production (NEAP)

    Time frame: 3 months post randomization

    mEq/day by the kidney

  3. Net Endogenous Acid Production (NEAP)

    Time frame: Baseline

    mEq/day by the kidney

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: BICARB

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2016
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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