HealthyNCT01394146
Impact of Food Additives on Phosphorus Metabolism
A study testing Research diet in people with Healthy, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Research diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, 19 - 45 years of age
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.
Read the 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.
- Conditions
- Healthy
- Being tested
- Research diet
- Keywords
- phosphorus-based food additives, phosphorus metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with healthy kidney function | Experimental | Not described Receives: Other: Research diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
FGF23
Change in FGF23 levels
Measured: 2 weeks
PTH
Change in PTH levels over 2 weeks
Measured: 2 weeks
Serum phosphate
Change in serum phosphate over two weeks
Measured: 2 weeks
Secondary outcomes (2)
Insulin sensitivity as measured by HOMA-IR
changes in HOMA-IR over two weeks
Measured: 2 weeks
Brachial flow mediated dilatation measured by ultrasound
change in flow mediated dilatation over two weeks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham
- Investigators
- Orlando M Gutierrez, MD, MMSc, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394146
- Sponsor's protocol ID
- F110118001
- Status last verified
- Sep 2015
- First submitted
- 12 Jul 2011
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32278118Gutierrez 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.
PubMed 26323022
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Food Additives on Phosphorus Metabolism
- ClinicalTrials.gov ID
- NCT01394146
- Acronym / sponsor ID
- F110118001
- Conditions
- Healthy
- Keywords
- phosphorus-based food additives, phosphorus metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with healthy kidney function | Experimental | Other: Research diet |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers, 19 - 45 years of age
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research dietParticipants 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). | Other | Subjects with healthy kidney function |
Primary outcome
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
2 secondary outcomes
Insulin sensitivity as measured by HOMA-IR
Time frame: 2 weeks
Brachial flow mediated dilatation measured by ultrasound
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Derived from this study: PubMed 32278118Gutierrez 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.
- Derived from this study: PubMed 26323022Gutierrez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlando M Gutierrez, MD, MMSc principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research diet in people with Healthy, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FGF23 (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394146, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.