Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function

NCT01890811 | Withdrawn

• 1 other identifier: 2013-0294
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. Attempts to reverse weight and muscle loss in CKD and improve nutritional status by nutritional supplementation have been unsuccessful and there are currently no approved therapies. Purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CKD patients compared to matched healthy controls. Additionally, to examine whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy controls. This will provide required information that will lead to implement new strategies to develop optimal nutritional regimen in order to enhance nutritional status, quality of life and survival in relation to kidney disease.

Conditions

Chronic Kidney Failure

Keywords

CKD; Hemodialysis; Protein Digestion; Fat Digestion; Gut Function; Glucose Absorption; Muscle Function

Outcome Measures

Primary Outcomes (1)

• Net whole-body protein synthesis

  Change in whole-body protein synthesis rate after intake of meal

  0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal

Secondary Outcomes (15)

• Citrulline Rate of appearance

  Postabsorptive state during 3 hours

• Glucose absorption

  7 hours

• Gut permeability

  7 hours

• Skeletal and respiratory muscle strength

  1 day

• Cognitive function

  1 day

Study Arms (1)

Boost High Protein

EXPERIMENTAL

Boost high protein with added spirulina

Dietary Supplement: Boost High Protein

Interventions

Boost High Protein DIETARY_SUPPLEMENT

Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.

Boost High Protein

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to walk, sit down and stand up independently
• Age 55 years or older
• Ability to lie in supine or elevated position for 7 hours
• Diagnosis of kidney disease; undergoing hemodialysis
• Clinically stable condition; no hospitalization 4 weeks preceding first study day
• Willingness and ability to comply with the protocol
• Healthy male or female according to the investigator's or appointed staff's judgment
• Ability to walk, sit down and stand up independently
• Age 55 years or older (older control group)
• Ability to lay in supine or elevated position for 7 hours
• No diagnosis of CKD
• Willingness and ability to comply with the protocol

You may not qualify if:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
• Established diagnosis of malignancy
• Established diagnosis of Insulin Dependent Diabetes Mellitus
• History of untreated metabolic diseases including hepatic disorder
• Presence of acute illness or metabolically unstable chronic illness
• Presence of fever within the last 3 days
• Body mass index \>40 kg/m2 (healthy subjects only)
• Any other condition that would interfere with the study or safety of the patient (according to the PI or nurse)
• Use of protein or amino acid containing nutritional supplements within 5 days of first study day
• Use of long-term oral corticosteroids or short course of oral corticosteroids within 4 weeks preceding first study day
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• (Possible) pregnancy

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (1)