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OpenTrials
Completed

NCT Number: NCT01394146

Impact of Food Additives on Phosphorus Metabolism

The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.

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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Research diet

Other

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).

Primary outcomes

  1. FGF23

    Time frame: 2 weeks

    Change in FGF23 levels

  2. PTH

    Time frame: 2 weeks

    Change in PTH levels over 2 weeks

  3. Serum phosphate

    Time frame: 2 weeks

    Change in serum phosphate over two weeks

Secondary outcomes

  1. Insulin sensitivity as measured by HOMA-IR

    Time frame: 2 weeks

    changes in HOMA-IR over two weeks

  2. Brachial flow mediated dilatation measured by ultrasound

    Time frame: 2 weeks

    change in flow mediated dilatation over two weeks

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2011
Registry last updated
Sep 30, 2015

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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