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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am healthy without diabetes, kidney disease, heart disease, or taking heart-related meds.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
oxygen uptake (VO2) during peak exercise
Secondary outcome measures
Cardiac output (CO)
Phosphocreatine (PCr) depletion
Resting ATP synthesis
+1 more

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

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,785 Total Patients Enrolled
Wanpen Vongpatanasin, MDPrincipal InvestigatorWanpen.Vongpatanasin@UTSouthwestern.edu
11 Previous Clinical Trials
681 Total Patients Enrolled

Media Library

Sodium Phosphate (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05147909 — N/A
Phosphate Overload Research Study Groups: Sodium Phosphate (NaPO4) then sodium chloride (NaCl), NaCl then NaPO4
Phosphate Overload Clinical Trial 2023: Sodium Phosphate Highlights & Side Effects. Trial Name: NCT05147909 — N/A
Sodium Phosphate (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05147909 — N/A
~76 spots leftby Mar 2027
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