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Protein-Restricted Diet for Inflammation

N/A
Recruiting
Led By Salvatore Scali, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy volunteers between 18 and 70 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2; day 4; day 7; day 14
Awards & highlights

Study Summary

This trial is testing whether a protein-restrictive diet can reduce stress responses to surgery.

Who is the study for?
This trial is for healthy volunteers aged between 18 and 70 who can follow the study protocol. It's not suitable for those under 18, pregnant individuals, prisoners, employees of the investigative team, or anyone with significant medical conditions like cancer, diabetes, IBD, advanced renal disease or a nut allergy.Check my eligibility
What is being tested?
The trial is studying how a short-term protein-restricted diet affects muscle energy and inflammation in the body. Participants will adhere to this special diet for four days while researchers collect blood serum and muscle tissue data.See study design
What are the potential side effects?
Since this is a dietary intervention focusing on protein restriction rather than medication or invasive procedures, side effects may include feelings of hunger or fatigue due to changes in usual eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy person aged between 18 and 70.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2; day 4; day 7; day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2; day 4; day 7; day 14 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 inflammatory cell composition

Trial Design

1Treatment groups
Experimental Treatment
Group I: Protein Restriction GroupExperimental Treatment1 Intervention
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,666 Total Patients Enrolled
Malcom Randall VA Medical CenterFED
7 Previous Clinical Trials
665 Total Patients Enrolled
Salvatore Scali, MDPrincipal InvestigatorUniversity of Florida

Media Library

4 Day Protein Restricted Diet Clinical Trial Eligibility Overview. Trial Name: NCT03995979 — N/A
Protein Restriction Research Study Groups: Protein Restriction Group
Protein Restriction Clinical Trial 2023: 4 Day Protein Restricted Diet Highlights & Side Effects. Trial Name: NCT03995979 — N/A
4 Day Protein Restricted Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995979 — N/A

Frequently Asked Questions

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

Who is eligible to join this experiment?

"To become an eligible candidate, one must have a healthy diet and be between 18-70 years old. The study is currently seeking 30 participants."

Answered by AI

Are there still opportunities for people to join this research endeavor?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical exploration is actively seeking participants, which it has been since September 9th 2019. There are two sites that need a total of 30 patients enrolled in order for the study to be complete."

Answered by AI

Is the enrollment criteria for this medical experiment restricted to those over 25?

"This medical experiment is available to those aged 18 or above, and below the age of 70."

Answered by AI

How many participants are there in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov evidences that this research project is currently enlisting participants; it was initially published on September 9th 2019 and most recently revised on June 30th 2022. Altogether, they are seeking to recruit 30 patients from two separate sites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Malcom Randall VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Inflammation and Protein Restriction
2019. "Inflammation and Protein Restriction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03995979.
~5 spots leftby Apr 2025
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