NCT03234361

Brief Summary

An increasing number of studies have indicated that most fast food and common grocery items, contain large amount of inorganic phosphate-based food additives , which are highly absorbable. The long-term cardiovascular consequences of a high phosphate diet are unknown but the existing database implicates phosphate excess as an independent risk factor for cardiovascular events in individuals with and without chronic kidney diseases (CKD). High phosphate consumption clearly induces BP elevation in rats with normal kidneys. However, the mechanisms underlying phosphate-induced hypertension and the relevance of these rodent studies to human hypertension have not been determined. We seek to investigate the role of high phosphate diet in human hypertension and assess the effect of high phosphate diet on muscle sympathetic nerve activity and the exercise pressor reflex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

5 years

First QC Date

July 26, 2017

Last Update Submit

November 2, 2022

Conditions

Hypertension

Keywords

HypertensionHigh phosphorus dietFGF 2324 hour ambulatory blood pressureMuscle sympathetic nerve

Outcome Measures

Primary Outcomes (1)

  • 24-hour Blood Pressure measured by Ambulatory Blood Pressure Monitor.

    Blood pressure will be measured through an ambulatory blood pressure monitoring device by Space Labs # 90217, worn by each participant after completing each phase, This will suggest if participant's blood pressure increased during high phosphorus phase as compared to low phosphorus phase.

    4 weeks

Secondary Outcomes (1)

  • Muscle Sympathetic Nerve Activity (MSNA)

    4 weeks after high phosphorus and 4 weeks after low phosphorus diet

Study Arms (2)

High Phosphate Phase

EXPERIMENTAL

All subjects will be on a low Pi diet containing 700mg/day of phosphate and 2 capsules of sodium phosphate with 500mg/day of phosphate for 4 weeks.

Dietary Supplement: High Phosphate Phase

Low Phosphate Phase

PLACEBO COMPARATOR

All subjects will be on a low Pi diet containing 700mg/day of phosphate and 2 capsules of sodium chloride for 4 weeks.

Dietary Supplement: Low Phosphate Phase

Interventions

High Phosphate PhaseDIETARY_SUPPLEMENT

2 capsules of sodium phosphate with 500mg/day of phosphate.

High Phosphate Phase
Low Phosphate PhaseDIETARY_SUPPLEMENT

2 capsules of sodium chloride.

Low Phosphate Phase

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • º ≥ 18 years of age
  • º Stage 1 Prehypertension (office BP 120-129/80-84 mmHg and normal ABPM \<130/80)

You may not qualify if:

  • º Diabetes mellitus or other systemic disease
  • º Cardiopulmonary disease
  • º Treatment with antihypertensive medications
  • º eGFR\< 60 ml/min/1.73m2
  • º Pregnancy
  • º Hypersensitivity to nitroprusside or phenylephrine
  • º Psychiatric illness
  • º H/o substance abuse or current smoker
  • º H/o malignancy
  • º Serum Phos \<2.4 mg/dL or \>4.5 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (7)

  • Sullivan CM, Leon JB, Sehgal AR. Phosphorus-containing food additives and the accuracy of nutrient databases: implications for renal patients. J Ren Nutr. 2007 Sep;17(5):350-4. doi: 10.1053/j.jrn.2007.05.008.

    PMID: 17720105BACKGROUND

  • Benini O, D'Alessandro C, Gianfaldoni D, Cupisti A. Extra-phosphate load from food additives in commonly eaten foods: a real and insidious danger for renal patients. J Ren Nutr. 2011 Jul;21(4):303-8. doi: 10.1053/j.jrn.2010.06.021. Epub 2010 Nov 5.

    PMID: 21055967BACKGROUND

  • Ketteler M, Wolf M, Hahn K, Ritz E. Phosphate: a novel cardiovascular risk factor. Eur Heart J. 2013 Apr;34(15):1099-101. doi: 10.1093/eurheartj/ehs247. Epub 2012 Oct 7. No abstract available.

    PMID: 23045267BACKGROUND

  • Karp H, Ekholm P, Kemi V, Itkonen S, Hirvonen T, Narkki S, Lamberg-Allardt C. Differences among total and in vitro digestible phosphorus content of plant foods and beverages. J Ren Nutr. 2012 Jul;22(4):416-22. doi: 10.1053/j.jrn.2011.04.004. Epub 2011 Jul 13.

    PMID: 21741857BACKGROUND

  • Suzuki Y, Mitsushima S, Kato A, Yamaguchi T, Ichihara S. High-phosphorus/zinc-free diet aggravates hypertension and cardiac dysfunction in a rat model of the metabolic syndrome. Cardiovasc Pathol. 2014 Jan-Feb;23(1):43-9. doi: 10.1016/j.carpath.2013.06.004. Epub 2013 Aug 8.

    PMID: 23932324BACKGROUND

  • Scanni R, vonRotz M, Jehle S, Hulter HN, Krapf R. The human response to acute enteral and parenteral phosphate loads. J Am Soc Nephrol. 2014 Dec;25(12):2730-9. doi: 10.1681/ASN.2013101076. Epub 2014 May 22.

    PMID: 24854273BACKGROUND

  • Hu MC, Shi M, Cho HJ, Adams-Huet B, Paek J, Hill K, Shelton J, Amaral AP, Faul C, Taniguchi M, Wolf M, Brand M, Takahashi M, Kuro-O M, Hill JA, Moe OW. Klotho and phosphate are modulators of pathologic uremic cardiac remodeling. J Am Soc Nephrol. 2015 Jun;26(6):1290-302. doi: 10.1681/ASN.2014050465. Epub 2014 Oct 17.

    PMID: 25326585BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Wapen Vongpatanasin, MD

    UT southwestern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

October 16, 2017

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

US(2)