Effects of Soluble Phosphate in Humans

Study Overview
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Brief Summary
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The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.

Official Title
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The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: P1000/Ca0
* Dietary Supplement: P1000/Ca500
* Dietary Supplement: P1000/Ca1000
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18-60 years physical health Exclusion Criteria: postmenopausal women kidney diseases diabetes mellitus metabolic diseases osteoporosis intake of dietary supplements pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P1000/Ca0<br> | Dietary Supplement: P1000/Ca0<br>* 22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]<br>Dietary Supplement: Placebo<br>* all participants consume two weeks before intervention the beverage without phosphate and calcium<br>|
| Experimental: P1000/Ca500<br> | Dietary Supplement: P1000/Ca500<br>* 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]<br>Dietary Supplement: Placebo<br>* all participants consume two weeks before intervention the beverage without phosphate and calcium<br>|
| Experimental: P1000/Ca1000<br> | Dietary Supplement: P1000/Ca1000<br>* 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]<br>Dietary Supplement: Placebo<br>* all participants consume two weeks before intervention the beverage without phosphate and calcium<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: P1000/Ca0<br>* 22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]<br>Dietary Supplement: P1000/Ca500<br>* 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]<br>Dietary Supplement: P1000/Ca1000<br>* 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting phosphate concentration in blood |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium and phosphorus metabolism | parameters of phosphate and calcium metabolism (1,25-OHD; 25-OHD;FGF23;PTH) parameters of bone formation and resorption (osteocalcin, P1NP, CTX) minerals in plasma, faeces and urine | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soluble phosphate, phosphorus metabolism, calcium metabolism, bone metabolism, human study