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Completed

NCT Number: NCT00597025

Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.

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Key information

Conditions

End Stage Renal Disease Blood Protein Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hypoalbuminemia Hypoproteinemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Satellite Healthcare, Inc., Mountain View, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
  • 18 years of age or older.
  • Must have a reasonable expectation of remaining on treatment for at least 3 months.
  • Must have an average serum albumin of <3.5 g/dL over the three months prior to entry into the study.
  • Must be able to understand and sign the informed consent.
  • Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.

Exclusion criteria

  • Allergy to protein, milk, nuts or wheat.
  • Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
  • Severe acidosis defined as pre-dialysis serum bicarbonate levels of <15 mEq/L.
  • Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
  • Hospitalization for an infectious condition within 4 weeks prior to study entry.
  • Planned surgery within the three month study period including planned kidney transplantation.

Treatment and study plan

Protein Food Bar Intelligent Indulgence

Dietary Supplement

Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months

Primary outcomes

  1. The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.

    Time frame: Each month for the three months.

  2. Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate.

    Time frame: Each month for 3 months

Secondary outcomes

  1. Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period

    Time frame: Month 3

  2. Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars.

    Time frame: Each month for 3 months

  3. Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored

    Time frame: Each month for 3 months

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 17, 2008
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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