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Dietary Supplement

Dietary Phosphate Impact on Phosphate Overload

N/A

Recruiting

Led By Wanpen Vongpatanasin, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The randomized crossover trial will be performed 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.

Be older than 18 years old

Must not have

History of active malignancy

History of cardiopulmonary disease or chronic kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial in mice shows that a high phosphate diet leads to reduced activity and metabolism. The results might not be relevant for humans.

Who is the study for?

This trial is for healthy adults without diabetes, chronic kidney disease, heart disease, or those on blood pressure medications. Participants should not be pregnant, have normal phosphate levels in their blood, and no history of psychiatric illness, active cancer or substance abuse including smoking.

What is being tested?

The study tests the effects of dietary phosphate (found in many foods) on exercise ability and belly fat. It compares taking sodium phosphate to sodium chloride (table salt), looking at how these supplements might affect physical activity and metabolism.

What are the potential side effects?

Potential side effects may include an imbalance of electrolytes due to high phosphate intake which can lead to issues with muscle function or cardiovascular health. Sodium intake could also impact blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy without diabetes, kidney disease, heart disease, or taking heart-related meds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer.

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I have a history of heart, lung, or kidney disease.

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My kidney function is reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

oxygen uptake (VO2) during peak exercise

Secondary study objectives

Cardiac output (CO)

Phosphocreatine (PCr) depletion

Resting ATP synthesis

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sodium Phosphate (NaPO4) then sodium chloride (NaCl)Experimental Treatment2 Interventions

Participants will be asked to take 2 capsules daily of Sodium Phosphate (containing a total of 500 mg of Pi, 372mg of sodium) ) for 4 weeks during the high Pi phase (total Pi intake 1,200 mg/d). Then, participants will be asked to take 2 capsules of Sodium Chloride (NaCl, containing a total of 372mg of sodium) to match Na content to Sodium Phosphate without extra Pi daily for 4 weeks during the low Pi phase (total Pi intake = 700 mg/d).

Group II: NaCl then NaPO4Experimental Treatment2 Interventions

Participants will be asked to take 2 capsules daily of Sodium Chloride (NaCl, containing a total of 372mg of sodium) for 4 weeks during the low Pi phase (total Pi intake = 700 mg/d). Then, participants will be asked to take 2 capsules of Sodium Phosphate daily for 4 weeks Sodium Phosphate (containing a total of 500 mg of Pi, 372mg of sodium) for 4 weeks during the high Pi phase (total Pi intake 1,200 mg/d).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium Chloride

2003

Completed Phase 4

~2650

0 / 4Eligibility criteria met