RecruitingNot applicable

Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 2 weeks
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After the run-in period, all participants will be maintained on a low Pi diet (700 mg/d) and a normal Na diet of approximately 3,128 mg/d throughout the study for 8 weeks."
  • "NaCl tablets and the study subjects will be blinded to the type of supplement they receive."
  • "Subsequently, participants will stop the first study supplement and undergo washout for 2 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how eating extra phosphate affects exercise ability and fat deep inside the belly. Phosphate is a mineral found in food. The study is for otherwise healthy people without diabetes, kidney disease, or heart and blood vessel disease.

Studies in mice demonstrated that dietary phosphate (Pi) loading that mimic the level of US adult consumption leads to reduced spontaneous locomotor activity, exercise capacity, and reduced resting metabolic rate when in normal mice by impairing skeletal muscle mitochondrial function and fat oxidation. However, relevance of this findings in humans remains unknown.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Otherwise healthy, with no diabetes, long-term kidney disease, or heart and blood vessel disease.
  • Not taking medicines that affect blood vessels and could change how the heart and blood vessels respond to exercise.

Who can't join

  • History of heart or lung disease, or long-term kidney disease.
  • Taking medicine for high blood pressure.
  • Kidney filtering test result (eGFR) below 60.
  • Diabetes or another illness that affects the whole body.
  • Pregnant or allergic to sodium phosphate.
  • Any history of substance abuse or current cigarette smoking.
  • Any history of mental illness or a history of active cancer.
  • Blood phosphorus level below 2.4 or above 4.5 mg/dL.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: The randomized crossover trial will be performed in on otherwise healthy subjects without diabetes mellitus, chronic kidney disease (CKD), preexisting cardiovascular disease or treatment with any vasoactive agent that might alter cardiovascular responses to exercise. Exclusion Criteria: 1. history of cardiopulmonary disease or chronic kidney disease, 2. treatment with antihypertensive medications, 3. estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2, (4) diabetes mellitus or other systemic illness, (5) pregnancy, (6) hypersensitivity to sodium phosphate, (7) any history of substance abuse or current cigarette use, (8) any history of psychiatric illness, (9) history of active malignancy, (10) serum phosphorus \< 2.4 or \> 4.5 mg/dL.

Study sites (1)

TX

  • University of Texas Southwestern · Dallas, TX 75209John Giacona, PA-C · Study contactMore trials in Dallas