Healthy Clinical Trial
Official title:
Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community-Living Adults (Phosphate and Fibroblast Growth Factor 23 [FGF23]: Dietary and Molecular Mediators of Health and Disparities in Cardiovascular and Kidney Diseases)
Verified date | March 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to learn more about how common food additives can affect phosphorus metabolism in people with normal kidney function and people with chronic kidney disease.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 5, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - (i.) Inclusion criteria for healthy volunteers: =18 years of age, normal kidney function (eGFR > 60 and normal urinalysis). Exclusion Criteria: - Exclusion criteria for healthy volunteers will include: - current smoking - extreme obesity (BMI = 35 kg/m2) - pregnancy or breastfeeding - conditions affecting phosphate metabolism (e.g., hyper- or hypothyroidism; irregular menses for menstruating women) - current intake of medications that impact phosphate metabolism (high-dose vitamin D, chronic antacid use) - current use of blood pressure medications - abnormal serum phosphate (= 4.6 or < 2.5 mg/dl) or calcium levels (= 10.6 or < 8.5 mg/dl) - severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men). - Inability to receive weekly shipments of food at home. - Requirement for any special diet other than a regular diet. - Allergies to any foods in the standardized diets (ii.) Inclusion criteria for CKD patients: =18 years of age, eGFR 20-50 ml/min Exclusion criteria for CKD patients will include: - clinical need for a low potassium, low sodium or low protein diet - new or recent change (<3 months) in dosage of medications known to impact vascular reactivity - current smoking - poorly controlled hypertension (=160/100 mmHg) - extreme obesity (BMI = 35 kg/m2) - pregnancy or breastfeeding - conditions affecting phosphate metabolism (e.g., hyper- or hypothyroidism) - current intake of medications that impact phosphate metabolism (e.g., high-dose vitamin D) - abnormal serum phosphate (= 4.6 or < 2.5 mg/dl) or calcium levels (= 10.6 or < 8.5 mg/dl) - severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men). - Inability to receive weekly shipments of food at home. - Allergies to any foods in the standardized diets |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in circulating fibroblast growth factor 23 (FGF23) concentrations | Longitudinal change in FGF23 concentrations over 8 weeks | 8 weeks | |
Primary | Change in brachial flow-mediated dilatation (FMD) | Longitudinal changes in FMD over 8 weeks | 8 weeks | |
Primary | Change in pulse wave velocity (PWV) | longitudinal changes in PWV over 8 weeks | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |