NCT02020785

Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23

Randomized Cross-over Study Examining the Effects of Phosphorus Additives on Urinary Albumin Excretion and Fibroblast Growth Factor-23

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. In this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. Then, participants will be randomized to a higher phosphorus period (\~2gm/d) and a lower phosphorus period (\~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives. The investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (FGF-23) during the higher phosphorus period compared to the lower phosphorus period.

Detailed description

The Study of Dietary Additive Phosphorus on Proteinuria and FGF-23 (SODA-POP) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate \>= 45 ml/min/1.73m2; and urine albumin/creatinine ratio \>=17 mg/g for men or \>=25 mg/g for women).

Conditions

• Albuminuria

Interventions

Type	Name	Description
OTHER	Higher phosphorus period	Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks. All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.
OTHER	Lower phosphorus period	Commercially-available unaltered food/beverage products without phosphorus additives (\<10mg/d of phosphorus) will be given for 3 weeks. All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-12-25
• Last updated: 2019-06-05
• Results posted: 2019-06-05

Locations

1 site across 1 country: United States