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Effects of High Dietary Fiber Supplementation in Diabetic Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01838330
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Brief Summary:

Loss of kidney function results in accumulation in the blood of molecules that are either excreted or metabolized by the kidney. Collectively, these molecules are termed Uremic Retention Molecules (URMs) or toxins. It is increasingly recognized that colonic bacterial metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity. Indeed, these URMs have been linked to increased levels of inflammation markers, chronic kidney disease (CKD) progression, cardiovascular disease and overall mortality in CKD and/ or hemodialysis patients. Therefore, interventions that target the production or absorption of URMs from the gut might decrease inflammation and oxidative stress that are commonly seen in the uremic milieu. The National Health and Nutrition Examination Survey III (NHANES III) data show that high dietary fiber intake is associated with decreased serum levels of C-reactive protein (CRP) in those with and without CKD and these associations are much stronger in the CKD population. A possible explanation of this effect is that a high fiber diet in CKD patients modulates the bacterial production, intestinal absorption and finally the serum levels of URMs like p-cresyl sulfate and indoxyl sulfate, which in turn results in decrease in inflammation.

OBJECTIVES:

Hypothesis:

  1. Higher serum levels of markers of inflammation such as high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF) -α seen in stage 4 CKD (estimated Glomerular Filtration Rate 15-29 ml/min/1.73 m2) compared to stage 2 CKD (estimated Glomerular Filtration Rate 60-89 ml/min/1.73 m2) is partly explained by the higher circulating levels of URMs (p-cresyl sulfate and indoxyl sulfate) in stage 4 CKD, and
  2. Dietary supplementation in stage 4 CKD with 30g/d of a soluble fiber Psyllium (brand name-Metamucil TM) will decrease circulating URMs levels and thereby, decrease serum levels of inflammation markers and urinary levels of transforming growth factor (TGF)-β, a marker of kidney fibrosis.

Condition or disease Intervention/treatment Phase
Kidney Disease Dietary Supplement: psyllium Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of High Dietary Fiber Supplementation on Uremic Retention Molecules and Inflammation in Diabetic Chronic Kidney Disease (CKD)
Study Start Date : June 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chronic Kidney Disease Stage 3-4
Study participants with stage 3 or 4 CKD will receive 15 grams/day of soluble fiber psyllium for the first week, followed by 30 grams/day of a soluble fiber psyllium for 4 months.
Dietary Supplement: psyllium
15 grams/day for 1 week, followed by 30 grams/day for 4 months
Other Name: Metamucil

No Intervention: Chronic Kidney Disease Stage 1-2
Study participants with stage 1 or 2 CKD will not receive study treatment



Primary Outcome Measures :
  1. p-cresyl sulfate serum concentration [ Time Frame: 4 months ]
    Comparison of serum p-cresyl sulfate concentration between Stage 3-4 CKD subjects (following treatment with soluble fiber psyllium) and Stage 1-2 CKD subjects (having received no study treatment)


Secondary Outcome Measures :
  1. Indoxyl sulfate serum concentration [ Time Frame: 4 months ]
    Comparison of serum indoxyl sulfate concentration between Stage 3-4 CKD subjects (following treatment with soluble fiber psyllium) and Stage 1-2 CKD subjects (having received no study treatment)

  2. Interleukin-6 (IL-6) serum concentration [ Time Frame: 4 months ]
    Comparison of serum IL-6 concentration between Stage 3-4 CKD subjects (following treatment with soluble fiber psyllium) and Stage 1-2 CKD subjects (having received no study treatment)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with or without diabetes and Stage 1 or 2 CKD (estimated Glomerular Filtration Rate > 60 mL/min/1.73 m2) with urine dipstick positive for protein or urinary albumin/ creatinine > 30 mg/g of creatinine; or
  • Stage 3 or 4 CKD (estimated Glomerular Filtration Rate < 60 to 15 mL/min/1.73 m2).

Exclusion Criteria:

  • Pregnant women
  • Prisoners
  • Bowel obstruction
  • Enrolled in other interventional studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838330


Locations
United States, Utah
University of Utah nephrology clinics, the internal medicine and endocrinology clinics
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Nestor Almeida, MD University of Utah

Responsible Party: Srinvasan Beddhu, MD, Faculty Sponsor, University of Utah
ClinicalTrials.gov Identifier: NCT01838330     History of Changes
Other Study ID Numbers: IRB_00052609
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by Srinvasan Beddhu, University of Utah:
Kidney Disease
Fiber
Dietary Intervention

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals