NCT02620449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

4.5 years

First QC Date

November 25, 2015

Last Update Submit

March 10, 2021

Conditions

HealthyChronic Kidney Disease

Keywords

phosphorusfibroblast growth factor 23diet

Outcome Measures

Primary Outcomes (3)

  • Change in circulating fibroblast growth factor 23 (FGF23) concentrations

    Longitudinal change in FGF23 concentrations over 8 weeks

    8 weeks

  • Change in brachial flow-mediated dilatation (FMD)

    Longitudinal changes in FMD over 8 weeks

    8 weeks

  • Change in pulse wave velocity (PWV)

    longitudinal changes in PWV over 8 weeks

    8 weeks

Study Arms (1)

single arm study

EXPERIMENTAL
Other: Diet

Interventions

DietOTHER

Participants will be fed a low-additive diet as the primary intervention

single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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.
  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 40359505DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Orlando Gutierrez, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 3, 2015

Study Start

August 28, 2015

Primary Completion

March 5, 2020

Study Completion

March 30, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

US(1)