Impact of Food Additives on Phosphorus Metabolism

NCT01394146 | Completed

• 1 other identifier: F110118001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

phosphorus-based food additives; phosphorus metabolism

Outcome Measures

Primary Outcomes (3)

• FGF23

  Change in FGF23 levels

  2 weeks

• PTH

  Change in PTH levels over 2 weeks

  2 weeks

• Serum phosphate

  Change in serum phosphate over two weeks

  2 weeks

Secondary Outcomes (2)

• Insulin sensitivity as measured by HOMA-IR

  2 weeks

• Brachial flow mediated dilatation measured by ultrasound

  2 weeks

Study Arms (1)

Subjects with healthy kidney function

EXPERIMENTAL

Other: Research diet

Interventions

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).

Subjects with healthy kidney function

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers, 19 - 45 years of age

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Gutierrez OM, Porter AK, Viggeswarapu M, Roberts JL, Beck GR Jr. Effects of phosphorus and calcium to phosphorus consumption ratio on mineral metabolism and cardiometabolic health. J Nutr Biochem. 2020 Jun;80:108374. doi: 10.1016/j.jnutbio.2020.108374. Epub 2020 Mar 19.

  PMID: 32278118 DERIVED

• Gutierrez OM, Luzuriaga-McPherson A, Lin Y, Gilbert LC, Ha SW, Beck GR Jr. Impact of Phosphorus-Based Food Additives on Bone and Mineral Metabolism. J Clin Endocrinol Metab. 2015 Nov;100(11):4264-71. doi: 10.1210/jc.2015-2279. Epub 2015 Aug 31.

  PMID: 26323022 DERIVED

Study Officials

• Orlando M Gutierrez, MD, MMSc

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 14, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

US (1)