The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status

NCT02046746 | Completed

• 1 other identifier: DA03
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids in maintaining nutritional status.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Serum Albumin

  Change from Month 0 to Month 6

Secondary Outcomes (6)

• Subjective Global Assessment

  Change from Month 0 to Month 6

• Dietary Intake Compliance

  Change from Month 0 to Month 6

• Hand Grip Strength

  Change from Month 0 to Month 6

• Appetite

  Change from Month 0 to Month 6

• Body Mass Index

  Change from Month 0 to Month 6

Study Arms (1)

Oral Nutritional Supplement (ONS)

EXPERIMENTAL

1-2 serving per day of a renal specific oral nutritional supplement

Other: Oral Nutritional Supplement (ONS)

Interventions

Oral Nutritional Supplement (ONS) OTHER

renal specific commercially available ONS

Oral Nutritional Supplement (ONS)

Eligibility Criteria

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

You may qualify if:

• Subject, or subject's legally acceptable representative (LAR), has voluntarily signed and dated an informed consent form (ICF), approved by an IEC/IRB, and provided Health Insurance Portability and Accountability Act (HIPAA)
• Subject is \>18 years of age.
• Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3b to 5.
• Subject has an eGFR 45 and 10 ml/min/1.73m2 at screening.
• Subject is a male or non-pregnant female at least six weeks postpartum and non-lactating.
• Subject with CKD is either:
• not diagnosed with Type 2 Diabetes Mellitus (T2DM) OR
• diagnosed with T2DM and had no changes in glycemic medication (dose or type) for at least 2 months prior to screening
• Subject has a serum albumin 3.0 g/dl at screening.
• Subject has a BMI 30 kg/m2.
• If diagnosed with T2DM, subject has A1c level 9.0% at screening.
• Subject is not scheduled or expected to receive dialysis in the next 18 months.
• Subject's life expectancy is 18 months determined by the study physician.
• Subject is willing to follow the protocol as described.
• With regard to ONS use the subject must qualify as one of the following:

You may not qualify if:

• Subject has type 1 diabetes.
• Subject is considered malnourished (SGA = 1 to 3).
• Subject has received intravenous albumin treatment within the last 6 months.
• Subject has overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
• Subject has poorly controlled chronic hypertension
• Subject has had major surgery, inpatient or outpatient, requiring \>7 days of hospitalization in the last 3 weeks prior to screening visit,
• Subject has a known chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy
• Subject is missing, or has had an amputation of, a limb.
• Subject has had a significant cardiovascular event
• Subject has a known obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
• Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
• Subject is currently consuming, or cannot refrain from taking, medications/dietary supplements/herbal preparations or substances,
• Subject is known to be allergic or intolerant to any ingredient found in the study product.
• Subject is considered unsuitable for the study based on the study physician's assessment.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (2)

Kaohsiung Medical University Hospital (KMUH)

Kaohsiung City, 80708, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Owen Kelly, Ph.D

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)