← Back to Search

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 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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,651 Total Patients Enrolled

Wanpen Vongpatanasin, MDPrincipal InvestigatorWanpen.Vongpatanasin@UTSouthwestern.edu

11 Previous Clinical Trials

716 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for this investigation thus far?

"Affirmative. Clinicaltrials.gov states that this clinical investigation, which was first made visible on September 14th 2022, is currently recruiting participants. The study requires 124 individuals from a single medical centre to complete enrollment."

Answered by AI

Is the age limit for enrolment in this experiment restricted to under 40?

"The parameters of this clinical trial indicate that only individuals between the ages 18 and 80 are eligible for enrollment. For those under 18, there is a separate study with 9 participants enrolled so far; similarly, 57 people over 65 have already been admitted to another research program."

Answered by AI

Is the opportunity available to participate in this experiment still open?

"Affirmative. Data hosted on clinicaltrials.gov attest to the active recruitment of this medical experiment, which was originally launched on September 14th 2022 and last revised on September 30th 2022. A total of 124 people need to be enrolled from a single location."

Answered by AI

Who is the target demographic for this clinical experiment?

"Aspiring participants of this trial must meet the criteria for visceral obesity, and be at least 18 years old but no older than 80. To achieve their research goals, 124 volunteers are needed in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity

Wanpen Vongpatanasin 2022. "Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05147909.