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Impact of Food Additives on Phosphorus Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394146
First Posted: July 14, 2011
Last Update Posted: September 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham
  Purpose
The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.

Condition Intervention
Healthy Other: Research diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Impact of Food Additives on Phosphorus Metabolism

Resource links provided by NLM:


Further study details as provided by Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham:

Primary Outcome Measures:
  • FGF23 [ Time Frame: 2 weeks ]
    Change in FGF23 levels

  • PTH [ Time Frame: 2 weeks ]
    Change in PTH levels over 2 weeks

  • Serum phosphate [ Time Frame: 2 weeks ]
    Change in serum phosphate over two weeks


Secondary Outcome Measures:
  • Insulin sensitivity as measured by HOMA-IR [ Time Frame: 2 weeks ]
    changes in HOMA-IR over two weeks

  • Brachial flow mediated dilatation measured by ultrasound [ Time Frame: 2 weeks ]
    change in flow mediated dilatation over two weeks


Enrollment: 54
Study Start Date: April 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with healthy kidney function Other: Research diet
Participants will be provided specially prepared meals to eat at home for two weeks. During the first week, participants will eat foods that do not have any phosphorus-based food additives in them (this is called the control diet). During the second week, participants will eat foods that all have phosphorus-based food additives in them (called the intervention diet).

Detailed Description:
Phosphorus is a mineral that is found in foods such as dairy products, nuts, and meat, and is important for strengthening the bones. However, too much phosphorus in the blood may be bad for the health of your heart and blood vessels. The kidneys keep the blood levels of phosphorus normal by getting rid of extra phosphorus in the urine. New research has found that common forms of food additives that are high in phosphorus may increase blood phosphorus levels in individuals with kidney disease. In addition, these food additives may increase blood levels of hormones that control phosphorus such as parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23). Like high blood phosphorus levels, high levels of PTH and FGF23 in the blood may also be bad for the health of your heart and blood vessels. In this study, the investigators would like to examine the effects of food additives on blood levels of phosphorus, PTH and FGF23 in individuals with normal kidney function.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, 19 - 45 years of age

Exclusion Criteria:

  • abnormal urinalysis—presence of hematuria, proteinuria, or leukocyturia.
  • pregnancy or breast-feeding
  • Medical conditions impacting phosphate metabolism—primary hyperparathyroidism; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or liver dysfunction; hyper- or hypothyroidism; irregular menses for female subjects.
  • Body Mass Index (BMI) ≥ 30 g/m2 since obesity is independently associated with impaired phosphorus metabolism.
  • Medications known to affect phosphorus metabolism— current use of phosphorus supplements, high-dose or activated vitamin D compounds, regular antacid or laxative use, anticonvulsants.
  • Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394146


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Orlando M Gutierrez, MD, MMSc University of Alabama at Birmingham
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orlando M. Gutierrez, MD, MMSc, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01394146     History of Changes
Other Study ID Numbers: F110118001
First Submitted: July 12, 2011
First Posted: July 14, 2011
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham:
phosphorus-based food additives
phosphorus metabolism