Effect of Phosphorus Additives on the Metabolome in Healthy Adults
Condition: Metabolic Syndrome; Insulin Sensitivity; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      This study evaluates the effect of phosphorus supplementation on the human metabolome. The
      investigators will do so by conducting a cross-over study in healthy adults consuming a study
      diet (normal diet supplemented by neutral sodium phosphorus, 1 gram/day) for seven days and a
      control diet (normal diet supplemented by sodium and potassium chloride only) for seven days
      with a 28 day wash-out period in between. Untargeted metabolomic analyses will be done in
      serum samples obtained at the end of each diet period.
    

Detailed description: 
      Phosphorus is an essential micronutrient involved in a number of key biological processes.
      Excess phosphorus intake is linked to hypertension, heart failure, and disorders of bone and
      mineral metabolism. This has critical implications for public health in that dietary
      phosphorus consumption in the US far exceeds current recommendations for daily intake.

      Most studies that examined the adverse effects of excess phosphorus intake have focused on
      single tissue or cell specific processes. However, a full understanding of the systemic
      impact of nutritional phosphorus intake requires a more integrated biologic approach. The
      human metabolome represents the final end-product of the omics cascade, which can serve as an
      integrated measure of the total biological response to dietary exposures. Few studies have
      examined the impact of nutritional phosphorus intake on the human metabolome. Expanding the
      understanding of the effect of diet phosphorus on the metabolome has the potential to
      identify novel phosphorus-responsive pathways that may be therapeutic targets for reducing
      the development of hypertension, cardiovascular and kidney disease. The investigators will
      test the following hypothesis: consumption of a high phosphorus diet will result in
      significant changes in circulating metabolites associated with cardiometabolic health.

      This hypothesis is supported by published and preliminary studies showing that high
      phosphorus intake alters metabolic pathways with a wide variety of pathophysiologic effects.
      In the current application, the investigators propose to build on this work by investigating
      the effect of phosphorus consumption on the human metabolome using an untargeted approach.
      The investigators will do so by conducting a cross-over study in healthy adults consuming a
      study diet (normal diet supplemented by neutral sodium phosphorus, 1 gram/day) for seven days
      and a control diet (normal diet supplemented by sodium and potassium chloride only) for seven
      days with a 28 day wash-out period.
    

Intervention name(s): Phosphorus-supplemented study diet; Control Diet
Intervention type(s): Other; Other
Intervention description(s): Participants will be instructed to consume a normal diet and will take a total of 1,000 mg of supplemental phosphorus per day in the form of neutral sodium phosphorus (K-Phos neutral®) for 1 week.; Participants will be asked to consume a normal diet supplemented with sodium and potassium chloride tablets commensurate with the extra sodium and potassium content consumed during the study diet period for 1 week
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Eligible subjects will consume a phosphorus supplemented diet (study diet) and a sodium and potassium chloride supplemented diet (control diet), with cross-over to the other diet following a 24-day wash-out period. The order in which the diets are consumed will be randomly assigned.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Metabolome; Phosphorus; Nutrition