Effects of High Dietary Fiber Supplementation in Diabetic Chronic Kidney Disease

NCT01838330 | Completed DMC

• 1 other identifier: IRB_00052609
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Kidney Disease; Fiber; Dietary Intervention

Outcome Measures

Primary Outcomes (1)

• p-cresyl sulfate serum concentration

  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)

  4 months

Secondary Outcomes (2)

• Indoxyl sulfate serum concentration

  4 months

• Interleukin-6 (IL-6) serum concentration

  4 months

Study Arms (2)

Chronic Kidney Disease Stage 3-4

EXPERIMENTAL

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

Chronic Kidney Disease Stage 1-2

NO INTERVENTION

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

Interventions

psyllium DIETARY_SUPPLEMENT

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

Also known as: Metamucil

Chronic Kidney Disease Stage 3-4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

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

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Nestor Almeida, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Faculty Sponsor

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: April 24, 2013
• Study Start: June 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

US (1)