Effects of High Dietary Fiber Supplementation in Diabetic Chronic Kidney Disease

NCT ID: NCT01838330

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

psyllium

Intervention Type: DIETARY_SUPPLEMENT

15 grams/day for 1 week, followed by 30 grams/day for 4 months

Chronic Kidney Disease Stage 1-2

Study participants with stage 1 or 2 CKD will not receive study treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

psyllium

15 grams/day for 1 week, followed by 30 grams/day for 4 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Metamucil

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Srinvasan Beddhu

MD, Faculty Sponsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nestor Almeida, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah nephrology clinics, the internal medicine and endocrinology clinics

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB_00052609

Identifier Type: -

Identifier Source: org_study_id