Effect of Phosphorus Additives on the Metabolome in Healthy Adults
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| ClinicalTrials.gov Identifier: NCT03841786 |
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Recruitment Status :
Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : April 12, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolic Syndrome Insulin Sensitivity Cardiovascular Diseases | Other: Phosphorus-supplemented study diet Other: Control Diet | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| 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 |
| Official Title: | Effect of Phosphorus Additives on the Metabolome in Healthy Adults |
| Actual Study Start Date : | June 28, 2019 |
| Actual Primary Completion Date : | April 27, 2021 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Control diet
Participants will be asked to consume a normal diet supplemented with sodium chloride (sodium chloride tablets, USP, 1 gram; 3 tablets per day) and potassium chloride (Klor-Con, 8 mEq; 0.5 tablets per day) for 1 week.
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Other: Control Diet
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 |
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Experimental: Phosphorus-supplemented study diet
Participants will be instructed to consume a normal diet with supplemental phosphorus (K-Phos Neutral tablets, 250 mg; 4 tablets a day) for 1 week.
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Other: Phosphorus-supplemented study diet
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. |
- Untargeted Metabolomics [ Time Frame: 7 days ]Untargeted metabolomics will be the primary endpoint and will be performed on serum samples obtained for all participants at the end of each dietary period.
- Fibroblast growth factor 23 (FGF23) [ Time Frame: 7 days ]FGF23 concentrations will be measured at the end of each dietary period
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy volunteers, aged 18 - 45 years with normal kidney function (estimated glomerular filtration rate > 60 ml/min/1.73m2).
Exclusion Criteria:
- abnormal urinalysis-presence of hematuria, proteinuria, or leukocyturia. pregnancy or breast-feeding
- Medical conditions impacting phosphate metabolism-primary hyperparathyroidism; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or liver dysfunction; hyper- or hypothyroidism; irregular menses for female subjects.
- Medications known to affect phosphorus metabolism- current use of phosphorus supplements, high-dose or activated vitamin D compounds, regular antacid or laxative use, anticonvulsants.
- Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men), hyperkalemia (potassium > 5.0 mmol/L).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841786
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Orlando Gutierrez, M.D. | University of Alabama at Birmingham |
| Responsible Party: | Orlando M. Gutierrez, MD, MMSc, Primary Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT03841786 |
| Other Study ID Numbers: |
IRB-300002442 |
| First Posted: | February 15, 2019 Key Record Dates |
| Last Update Posted: | April 12, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Metabolome Phosphorus Nutrition |
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Cardiovascular Diseases Metabolic Syndrome Insulin Resistance |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |