Protein RestrictionNCT03995979

Inflammation and Protein Restriction

A study testing 4 Day Protein Restricted Diet in people with Protein Restriction and Diet, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Protein Restriction, Diet, Inflammation
What is being tested?: 4 Day Protein Restricted Diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesUnited States
Study dates: 9 Sep 2019to 16 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy volunteers between 18 and 70 years of age

Who cannot join

Age less than 18 years.
The presence of any significant medical condition that might significantly confound the collection of biological data in the study including cancer, diabetes, inflammatory bowel disease (IBD), Advanced Renal Disease, Nut Allergy
Unwilling to follow protocol
Participation in another interventional clinical trial.
Prisoners, pregnancy, or direct employees of the investigative team

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Malcom Randall VA Medical Center
Gainesville, Florida, 32608
UF Health---Vascular Surgery
Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity

There is strong scientific data that supports that short-term protein restrictive diets reduce surgical stress responses. The investigators are hoping to use the information collected from the blood serum and muscle tissue of healthy subjects to help understand the baseline and early changes in muscle energetic and cell-mediated inflammation. The study team hopes to use the data collected in this pilot study to compare with patients undergoing open abdominal aortic aneurysm (AAA) repair in a future study

Read the detailed description

Modulation of a patient's diet, specifically via short-term dietary protein restriction, can impact changes in cell energetics and dampen the normal subclinical inflammatory state. These changes can provide benchmarks for future research focused on using nutritional interventions aimed at improving the probability of a successful outcome following open aortic aneurysm surgery. The investigators will conduct a short term dietary restriction protocol to characterize these changes in a normal control cohort to be compared to patients which undergo surgery, to identify the optimal time points for sampling in the surgical population. These changes will be characterized by looking at inflammatory cells in the blood, proteins excreted in the urine, changes in microbiome signature identified by stool sample and oral swab, as well as changes in muscle energetics in small muscle biopsies.

Conditions: Protein Restriction, Diet, Inflammation
Being tested: 4 Day Protein Restricted Diet
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4 Day Protein Restricted DietOther
Also called Scandishake
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. They may also drink water. No food, other beverages, or alcohol may be consumed. The amount of diet to be consumed will be calculated for each patient based upon resting energy expenditures plus additional energy needs. These will be consumed by the study subjects at home in an unrestricted manner, in that they may be consumed at any point of time in the day.

Study groups in NCT03995979
Study group	Role	What they receive
Protein Restriction Group	Experimental	Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. Receives: Other: 4 Day Protein Restricted Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
Genomic sequencing along with taxonomic and functional pathways analysis is used to identify any compositional and functional changes in the intestinal microbiome of patients on short-term dietary restrictions in relation its anti-inflammatory effects on pre-operative conditioning,
Measured: Day 2; Day 4; Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 201916 Feb 2024

First posted24 Jun 2019
Study start9 Sep 2019
Primary completion16 Feb 2024
Study completion16 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Protein RestrictionStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03995979
Sponsor's protocol ID: IRB201900988 -V
Other IDs: NF/SGVHS
Status last verified: Dec 2024
First submitted: 21 Jun 2019
Last updated: 24 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity
ClinicalTrials.gov ID: NCT03995979
Acronym / sponsor ID: IRB201900988 -V
Conditions: Protein Restriction, Diet, Inflammation
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Malcom Randall VA Medical Center
Study start: 9 Sep 2019 (actual)
Primary completion: 16 Feb 2024 (actual)
Study completion: 16 Feb 2024 (actual)
First posted: 24 Jun 2019 (actual)
Results: Posted 24 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Protein Restriction Group	Experimental	Other: 4 Day Protein Restricted DietSubjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy volunteers between 18 and 70 years of age

Key exclusion criteria (5 listed)

Age less than 18 years.
The presence of any significant medical condition that might significantly confound the collection of biological data in the study including cancer, diabetes, inflammatory bowel disease (IBD), Advanced Renal Disease, Nut Allergy
Unwilling to follow protocol
Participation in another interventional clinical trial.
Prisoners, pregnancy, or direct employees of the investigative team

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
4 Day Protein Restricted DietAlso: ScandishakeSubjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. They may also drink water. No food, other beverages, or alcohol may be consumed. The amount of diet to be consumed will be calculated for each patient based upon resting energy expenditures plus additional energy needs. These will be consumed by the study subjects at home in an unrestricted manner, in that they may be consumed at any point of time in the day.	Other	Protein Restriction Group

Primary outcome

Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
Time frame: Day 2; Day 4; Day 7
Genomic sequencing along with taxonomic and functional pathways analysis is used to identify any compositional and functional changes in the intestinal microbiome of patients on short-term dietary restrictions in relation its anti-inflammatory effects on pre-operative conditioning,

Results and safety

Results posted to the registry on 24 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Protein Restriction Group	12	10

Primary outcome: Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.

Time frame: Day 2; Day 4; Day 7. Number. Unit: Number of immunity related genes

Measure	Protein Restriction Group n = 10
Differential expression of genes on Day 2 of DR compared to baseline	232
Differential expression of genes on day 4 DR compared to baseline	172
Differential expression of genes on day 7 DR compared to baseline	145
Total genes upregulated on day 2 of DR	93
Total genes upregulated on day 4 of DR	24
Total genes upregulated on day 7 of DR	85
Total genes downregulated on day 2 of DR	139
Total genes downregulated on day 4 of DR	148

Protein Restriction Group: p = 0.05, Paired t-test

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Protein Restriction Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): The specific diet used in this study,although advantageous for its feasibility in achieving the targeted percent protein goal and caloric restriction, may deviate from the ideal short-term protein-calorie dietary restriction (stDR). Moreover, observations could be attributed to the diet itself and not necessarily from protein or caloric restrictions. Lastly, this study lacks a description of the peripheral immune cell response.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Salvatore Scali, MD principal investigator

University of Florida

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 4 Day Protein Restricted Diet in people with Protein Restriction and Diet, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. (time frame: Day 2; Day 4; Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03995979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.