HealthyNCT02620449
Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community-Living Adults
A study testing Diet in people with Healthy and Chronic Kidney Disease, 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 common food additives can affect phosphorus metabolism in people with normal kidney function and people with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Kidney Disease
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2015to 30 Mar 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (i.) Inclusion criteria for healthy volunteers: ≥18 years of age, normal kidney function (eGFR > 60 and normal urinalysis).
Who cannot join
- current smoking
- extreme obesity (BMI ≥ 35 kg/m2)
- pregnancy or breastfeeding
- conditions affecting phosphate metabolism (e.g., hyper- or hypothyroidism; irregular menses for menstruating women)
- current intake of medications that impact phosphate metabolism (high-dose vitamin D, chronic antacid use)
- current use of blood pressure medications
Show all 23Show fewer
- abnormal serum phosphate (≥ 4.6 or < 2.5 mg/dl) or calcium levels (≥ 10.6 or < 8.5 mg/dl)
- severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men).
- Inability to receive weekly shipments of food at home.
- Requirement for any special diet other than a regular diet.
- Allergies to any foods in the standardized diets (ii.) Inclusion criteria for CKD patients: ≥18 years of age, eGFR 20-50 ml/min
- clinical need for a low potassium, low sodium or low protein diet
- new or recent change (<3 months) in dosage of medications known to impact vascular reactivity
- current smoking
- poorly controlled hypertension (≥160/100 mmHg)
- extreme obesity (BMI ≥ 35 kg/m2)
- pregnancy or breastfeeding
- conditions affecting phosphate metabolism (e.g., hyper- or hypothyroidism)
- current intake of medications that impact phosphate metabolism (e.g., high-dose vitamin D)
- abnormal serum phosphate (≥ 4.6 or < 2.5 mg/dl) or calcium levels (≥ 10.6 or < 8.5 mg/dl)
- severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men).
- Inability to receive weekly shipments of food at home.
- Allergies to any foods in the standardized diets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community-Living Adults (Phosphate and Fibroblast Growth Factor 23 [FGF23]: Dietary and Molecular Mediators of Health and Disparities in Cardiovascular and Kidney Diseases)
The purpose of the study is to learn more about how common food additives can affect phosphorus metabolism in people with normal kidney function and people with chronic kidney disease.
Read the detailed description
Disturbances in phosphate homeostasis are strongly associated with cardiovascular morbidity and mortality. High dietary phosphate intake plays a central role in the development of disturbed phosphate metabolism and is common in persons consuming typical American diets rich in processed and fast foods. An important reason for the high phosphate content of these foods is the widespread use of phosphate-based food additives in the food supply. Phosphate additives are heavily utilized by the food manufacturing industry to enhance the appearance, taste and shelf-life of processed foods, accounting for as much as 50% of total phosphate intake per day. Prior work from our group suggest that high phosphate additive intake has serious cardiovascular consequences. We showed that phosphate excess induces heart disease and inflammation in experimental studies, and associates with heart disease and death independently of classic risk factors in epidemiology studies. Further, we showed that high phosphate additive intake stimulates the secretion of fibroblast growth factor 23 (FGF23), a phosphate-regulatory hormone directly implicated in the pathogenesis of cardiovascular disease. Together, these data strongly suggest that high phosphate additive intake promotes cardiovascular disease, with important potential implications for efforts to reduce disparities in cardiovascular disease. This is because individuals with low socioeconomic status have limited means to purchase healthy foods, resulting in excessive consumption of processed foods rich in phosphate additives. Moreover, low income neighborhoods have a disproportionately high prevalence of individuals with chronic kidney disease and black individuals, both groups that have impaired ability to excrete excess phosphate. Together, these data support our overriding hypothesis that high phosphate additive intake is a novel target for reducing socioeconomic and racial disparities in cardiovascular. We will test this hypothesis in detailed feeding studies of 80 individuals fed standardized meals with low phosphate additive content for 6 weeks. We will investigate the impact of reducing phosphate additive intake on changes in FGF23 levels, inflammatory markers and vascular function, and test for effect modification by race and chronic kidney disease (CKD). The results of these studies will help determine whether high phosphate additive intake is a modifiable risk factor for disparities in cardiovascular disease.
- Conditions
- Healthy, Chronic Kidney Disease
- Being tested
- Diet
- Keywords
- phosphorus, fibroblast growth factor 23, diet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Participants will be fed a low-additive diet as the primary intervention
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | Not described Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating fibroblast growth factor 23 (FGF23) concentrations
Longitudinal change in FGF23 concentrations over 8 weeks
Measured: 8 weeks
Change in brachial flow-mediated dilatation (FMD)
Longitudinal changes in FMD over 8 weeks
Measured: 8 weeks
Change in pulse wave velocity (PWV)
longitudinal changes in PWV over 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start28 Aug 2015
- Primary completion5 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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 Gutierrez, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620449
- Sponsor's protocol ID
- F150728005
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2015
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Khan MB, Carnethon MR, Isakova T, Wolf M, Gutierrez OM. Effects of Lowering Dietary Phosphorus Additive Intake on Mineral Metabolism in Adults with and without CKD. Clin J Am Soc Nephrol. 2025 May 13;20(7):950-957. doi: 10.2215/CJN.0000000730.
PubMed 40359505
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community-Living Adults (Phosphate and Fibroblast Growth Factor 23 [FGF23]: Dietary and Molecular Mediators of Health and Disparities in Cardiovascular and Kidney Diseases)
- ClinicalTrials.gov ID
- NCT02620449
- Acronym / sponsor ID
- F150728005
- Conditions
- Healthy, Chronic Kidney Disease
- Keywords
- phosphorus, fibroblast growth factor 23, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 28 Aug 2015 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 3 Dec 2015 (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 common food additives can affect phosphorus metabolism in people with normal kidney function and people with chronic kidney disease.
Detailed description
Disturbances in phosphate homeostasis are strongly associated with cardiovascular morbidity and mortality. High dietary phosphate intake plays a central role in the development of disturbed phosphate metabolism and is common in persons consuming typical American diets rich in processed and fast foods. An important reason for the high phosphate content of these foods is the widespread use of phosphate-based food additives in the food supply. Phosphate additives are heavily utilized by the food manufacturing industry to enhance the appearance, taste and shelf-life of processed foods, accounting for as much as 50% of total phosphate intake per day. Prior work from our group suggest that high phosphate additive intake has serious cardiovascular consequences. We showed that phosphate excess induces heart disease and inflammation in experimental studies, and associates with heart disease and death independently of classic risk factors in epidemiology studies. Further, we showed that high phosphate additive intake stimulates the secretion of fibroblast growth factor 23 (FGF23), a phosphate-regulatory hormone directly implicated in the pathogenesis of cardiovascular disease. Together, these data strongly suggest that high phosphate additive intake promotes cardiovascular disease, with important potential implications for efforts to reduce disparities in cardiovascular disease. This is because individuals with low socioeconomic status have limited means to purchase healthy foods, resulting in excessive consumption of processed foods rich in phosphate additives. Moreover, low income neighborhoods have a disproportionately high prevalence of individuals with chronic kidney disease and black individuals, both groups that have impaired ability to excrete excess phosphate. Together, these data support our overriding hypothesis that high phosphate additive intake is a novel target for reducing socioeconomic and racial disparities in cardiovascular. We will test this hypothesis in detailed feeding studies of 80 individuals fed standardized meals with low phosphate additive content for 6 weeks. We will investigate the impact of reducing phosphate additive intake on changes in FGF23 levels, inflammatory markers and vascular function, and test for effect modification by race and chronic kidney disease (CKD). The results of these studies will help determine whether high phosphate additive intake is a modifiable risk factor for disparities in cardiovascular disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Experimental | Other: Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (i.) Inclusion criteria for healthy volunteers: ≥18 years of age, normal kidney function (eGFR > 60 and normal urinalysis).
Key exclusion criteria (23 listed)
- clinical need for a low potassium, low sodium or low protein diet
- new or recent change (<3 months) in dosage of medications known to impact vascular reactivity
- current smoking
- poorly controlled hypertension (≥160/100 mmHg)
- extreme obesity (BMI ≥ 35 kg/m2)
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 |
|---|---|---|
| DietParticipants will be fed a low-additive diet as the primary intervention | Other | single arm study |
Primary outcome
Change in circulating fibroblast growth factor 23 (FGF23) concentrations
Time frame: 8 weeks
Longitudinal change in FGF23 concentrations over 8 weeks
Change in brachial flow-mediated dilatation (FMD)
Time frame: 8 weeks
Longitudinal changes in FMD over 8 weeks
Change in pulse wave velocity (PWV)
Time frame: 8 weeks
longitudinal changes in PWV over 8 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 11 Mar 2021.
- Derived from this study: PubMed 40359505Khan MB, Carnethon MR, Isakova T, Wolf M, Gutierrez OM. Effects of Lowering Dietary Phosphorus Additive Intake on Mineral Metabolism in Adults with and without CKD. Clin J Am Soc Nephrol. 2025 May 13;20(7):950-957. doi: 10.2215/CJN.0000000730.
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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 Gutierrez, MD 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 Diet in people with Healthy and Chronic Kidney Disease, 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 23 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 11 Mar 2021. 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?
Change in circulating fibroblast growth factor 23 (FGF23) concentrations (time frame: 8 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 NCT02620449, which also lists 1 linked publication.
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 11 Mar 2021.