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Dietary Supplement

High-salt diet for Obesity

N/A

Waitlist Available

Led By Rachelle Crescenzi, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and each of 3 study visits occurring about every 7 days, to be completed in no less than 21 days.

Awards & highlights

Study Summary

This trial will compare how people react to salt in their diet versus how much salt their bodies actually absorb.

Eligible Conditions

Obesity
Cardiovascular Risk
Hypernatremia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following completion of all dietary supplements and washout, in no less than 21 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following completion of all dietary supplements and washout, in no less than 21 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and following completion of all dietary supplements and washout, in no less than 21 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Salt-sensitive blood pressure after low salt diet

Secondary outcome measures

Fat fraction of the legs

Kidney blood perfusion rate

Lymphatic stasis of the legs

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low- then high-salt dietExperimental Treatment2 Interventions

10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.

Group II: High- then low-salt dietExperimental Treatment2 Interventions

10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low-salt diet

2019

N/A

~20

High-salt diet

2019

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,213 Total Patients Enrolled

35 Trials studying Obesity

6,862 Patients Enrolled for Obesity

Rachelle Crescenzi, PhDPrincipal Investigator - Department of Radiology, Vanderbilt University Medical Center

Vanderbilt University Medical Center

2 Previous Clinical Trials

185 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are taking part in this clinical investigation?

"Affirmative. According to information stored on clinicaltrials.gov, this medical experiment is currently recruiting patients and was initially posted in February of 2019 with the latest update occurring in February 2022. 20 participants are needed from a single trial site."

Answered by AI

Does this clinical experiment have an upper age limit for participants?

"This clinical research project is open to qualified applicants aged 18 and up, but not over the age of 55."

Answered by AI

Are there any available openings for participants in this clinical investigation?

"This investigation, listed on clinicaltrials.gov and first published in February of 2019, is actively looking for participants. The trial details were most recently amended at the start of this year."

Answered by AI

To whom is the opportunity to join this investigation open?

"This clinical trial requires the recruitment of 20 individuals with obesity who meet a specific set of criteria such as adhering to study diets, having a BMI between 25 and 35 kg/m2, and being within the age range of 18-55 years."

Answered by AI

Recent research and studies

Journal of Magnetic Resonance ImagingJournal

Lymphedema Evaluation Using Noninvasive 3T MR Lymphangiography

Crescenzi, Rachelle, Paula M.C. Donahue, Katherine G. Hartley, Aditi A. Desai, Allison O. Scott, Vaughn Braxton, Helen Mahany, Sarah K. Lants, and Manus J. Donahue. 2017. “Lymphedema Evaluation Using Noninvasive 3T MR Lymphangiography”. Journal of Magnetic Resonance Imaging. Wiley. doi:10.1002/jmri.25670.

ObesityJournal

Tissue Sodium Content Is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema

Crescenzi, Rachelle, Adriana Marton, Paula M.C. Donahue, Helen B. Mahany, Sarah K. Lants, Ping Wang, Joshua A. Beckman, Manus J. Donahue, and Jens Titze. 2017. “Tissue Sodium Content Is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema”. Obesity. Wiley. doi:10.1002/oby.22090.

clinicaltrials.govStudy

Visualizing Vascular Mechanisms of Salt Sensitivity

Rachelle Crescenzi 2019. "Visualizing Vascular Mechanisms of Salt Sensitivity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03696433.