Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05147909
Status
Recruiting
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Conditions

  • Phosphate Overload
  • Physical Inactivity
  • Visceral Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Sodium Phosphate — DIETARY_SUPPLEMENT
    Sodium Phosphate 2 capsules daily (containing a total of 500 mg of Pi, 372mg of sodium)
  • Sodium Chloride — DIETARY_SUPPLEMENT
    Sodium Chloride 2 capsules daily (NaCl, containing a total of 372mg of sodium)

Study Details

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.

Key Dates

Start date
Sep 14, 2022
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Sodium Phosphate (NaPO4) then sodium chloride (NaCl)
    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).
  • Experimental: NaCl then NaPO4
    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).

Primary Outcome Measure

oxygen uptake (VO2) during peak exercise [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas SouthwesternDallasTexas75209
John Giacona, PA-C

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By research site
University of Texas Southwestern· Dallas, TX

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