Vascular DiseasesDRIVeSNCT04013412
Dietary Restriction in Vascular Surgery
A study testing Protein-Calorie Restriction in people with Vascular Diseases and Surgery, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Surgery
- What is being tested?
- Protein-Calorie Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater than 18 years old who present for one of the following elective procedures at Brigham and Women's Hospital
- Carotid artery endarterectomy
- Aortic/iliac aneurysm repair (open, and endovascular if groin cut down planned)
- Open lower extremity arterial procedures (bypasses, aneurysm repair, arterial and bypass graft reconstructions)
- Major amputation of the lower extremity (below knee and above knee amputations).
- Open hemodialysis access procedures
Who cannot join
- Patient intolerance or allergy to any of the ingredients in the PCR diet
- Active infection
- Pregnancy
- Malnutrition, based on abnormally low serum albumin (lower than 3 g/dL)
- Uncontrolled diabetes (HgbA1c greater than 12%)
- Substance dependency that could interfere with protocol adherence and assent as determined by the PI
Show all 10Show fewer
- Active non-cutaneous cancer under treatment with chemotherapeutics or radiation
- Emergency surgery
- Active participation in any another interventional or randomized study
- Participation in the current study within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. This study is a step in the long-term primary scientific objective to test the hypothesis that brief up regulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.
Read the detailed description
Hydrogen sulfide (H2S) has emerged as a critical gaseous signaling molecule with a role in multiple processes including ischemia-reperfusion (IR) injury, angiogenesis, intimal hyperplasia, and anti-inflammatory mechanisms. It even appears to hold anti-atherosclerotic properties. However, the gas is toxic with a half-life of minutes, and it can be rapidly oxidized. Furthermore, no clinically useful pharmacologic H2S donors have been developed to date. In a 2015 Cell paper, the study investigators link substantial upregulation of endogenous H2S to short-term manipulation of mammalian dietary intake: simple dietary restriction. The current project serves as the second phase in the accelerated translation of this important discovery toward clinical utility that may substantively impact the vascular patient at several levels: protection from IR injury, intimal hyperplasia, peri-procedural events such as stroke, cardiac dysfunction and myocardial infarction (MI), and promotion of angiogenesis.
Chronic protein and calorie dietary restriction (PCR; reduced food intake without malnutrition) is known for extending longevity in multiple species. PCR is also an established approach to positively impact metabolic fitness and resistance to multiple forms of acute stress. Despite these wide-ranging benefits, potential clinical applications have never been considered feasible in humans due to the practical difficulties associated with voluntary food restriction combined with the assumption that PCR benefits take a long time to accrue. Recent preclinical studies by the applicants reveal a rapid onset of PCR benefits against surgically induced traumatic inflammation, IR injury, and the fibroproliferative vascular response to injury in rodents. Mechanistically, rapid changes in adipose phenotype and associated adipokine profiles appear to underlie these benefits; but the key mediator appears to be endogenous H2S. This field thus stands poised to move to clinical utility, and vascular surgery offers an optimal risk/benefit ratio for translation of the PCR/H2S hypothesis.
For the current project the investigators will complete a randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative PCR diet in comparison to a normal ad libitum diet for 4 days before elective major vascular surgery. Both Endpoints relate to the long-term primary scientific objective to test the hypothesis that brief upregulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy titled Short-Term Endogenous Hydrogen Sulfide Upregulation (NCT03303534), the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.
Eighty subjects undergoing carotid artery endarterectomy, aortic aneurysm repair (open, and endovascular if groin cut down planned), open lower extremity arterial procedures (bypasses, aneurysm repair, arterial and bypass graft reconstructions), major amputation of the lower extremity (below knee and above knee amputations), or open hemodialysis access procedures for either symptomatic or asymptomatic disease will be recruited and enrolled at Brigham and Women's Hospital. Using a randomized (3:2), parallel design, patients will receive either the PCR diet (n=48; ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level), or continued routine ad libitum diet (n=32). Daily physical activity will be assessed by questionnaire to determine the activity factor for accurate calorie restriction calculations. Water intake is ad libitum for both cohorts, and both diets can be consumed throughout the day and night (except on the day of surgery). Patients will consume their assigned diets for the four days leading up to surgery until midnight the day of surgery when both cohorts will be fasted for the procedure (per standard clinical guidelines).
- Conditions
- Vascular Diseases, Surgery
- Being tested
- Protein-Calorie Restriction
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-Calorie RestrictionDietary supplement
Four day dietary intervention immediately before surgery of ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level.
| Study group | Role | What they receive |
|---|---|---|
| Protein-Calorie Restriction | Experimental | Four day dietary intervention immediately before surgery of ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level. Receives: Dietary Supplement: Protein-Calorie Restriction |
| Control | No intervention | Ad libitum diet for four days immediately before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outpatient compliance with protein calorie restriction
Patient compliance with the PCR diet will be assessed by food record analysis.
Measured: 1 Month
Comparison of H2S and related biological markers of stress
Biologic markers include: adipose phenotyping (quantification of adipokines, adipose derived hormones), leukocyte phenotyping and quantification via flow cytometry, and serum assays of IL-1beta, IL-6, IL-8, HGF, leptin, MCP-1, PAI-1, resistin, NGF, TNF, adiponectin, hydrogen sulfide (including production capacity) assays, insulin, lipid panels, FGF 21, pre-albumin, epinephrine, norepinephrine, dopamine, CBC with differential, basic metabolic panel including calcium. H2S and biologic markers will be compared at baseline, immediately before surgery, and the day after surgery.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start31 Dec 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3:2 randomization to short-term protein calorie restriction diet versus regular meals prior to elective major vascular surgery
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Keith Ozaki, M.D., F.A.C.S., Brigham and Women's Hospital
- Investigators
- Charles K Ozaki, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013412
- Sponsor's protocol ID
- 2018P002133
- Acronym
- DRIVeS
- Status last verified
- Sep 2020
- First submitted
- 24 Jun 2019
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hine C, Kim HJ, Zhu Y, Harputlugil E, Longchamp A, Matos MS, Ramadoss P, Bauerle K, Brace L, Asara JM, Ozaki CK, Cheng SY, Singha S, Ahn KH, Kimmelman A, Fisher FM, Pissios P, Withers DJ, Selman C, Wang R, Yen K, Longo VD, Cohen P, Bartke A, Kopchick JJ, Miller R, Hollenberg AN, Mitchell JR. Hypothalamic-Pituitary Axis Regulates Hydrogen Sulfide Production. Cell Metab. 2017 Jun 6;25(6):1320-1333.e5. doi: 10.1016/j.cmet.2017.05.003.
PubMed 28591635Longchamp A, Harputlugil E, Corpataux JM, Ozaki CK, Mitchell JR. Is Overnight Fasting before Surgery Too Much or Not Enough? How Basic Aging Research Can Guide Preoperative Nutritional Recommendations to Improve Surgical Outcomes: A Mini-Review. Gerontology. 2017;63(3):228-237. doi: 10.1159/000453109. Epub 2017 Jan 5.
PubMed 28052287Longchamp A, Tao M, Bartelt A, Ding K, Lynch L, Hine C, Corpataux JM, Kristal BS, Mitchell JR, Ozaki CK. Surgical injury induces local and distant adipose tissue browning. Adipocyte. 2015 Nov 20;5(2):163-74. doi: 10.1080/21623945.2015.1111971. eCollection 2016 Apr-Jun.
PubMed 27386152Robertson LT, Trevino-Villarreal JH, Mejia P, Grondin Y, Harputlugil E, Hine C, Vargas D, Zheng H, Ozaki CK, Kristal BS, Simpson SJ, Mitchell JR. Protein and Calorie Restriction Contribute Additively to Protection from Renal Ischemia Reperfusion Injury Partly via Leptin Reduction in Male Mice. J Nutr. 2015 Aug;145(8):1717-27. doi: 10.3945/jn.114.199380. Epub 2015 Jun 3.
PubMed 26041674Hine C, Harputlugil E, Zhang Y, Ruckenstuhl C, Lee BC, Brace L, Longchamp A, Trevino-Villarreal JH, Mejia P, Ozaki CK, Wang R, Gladyshev VN, Madeo F, Mair WB, Mitchell JR. Endogenous hydrogen sulfide production is essential for dietary restriction benefits. Cell. 2015 Jan 15;160(1-2):132-44. doi: 10.1016/j.cell.2014.11.048. Epub 2014 Dec 23.
PubMed 25542313Mauro CR, Tao M, Yu P, Trevino-Villerreal JH, Longchamp A, Kristal BS, Ozaki CK, Mitchell JR. Preoperative dietary restriction reduces intimal hyperplasia and protects from ischemia-reperfusion injury. J Vasc Surg. 2016 Feb;63(2):500-9.e1. doi: 10.1016/j.jvs.2014.07.004. Epub 2014 Aug 8.
PubMed 25124359Nguyen B, Tao M, Yu P, Mauro C, Seidman MA, Wang YE, Mitchell J, Ozaki CK. Preoperative diet impacts the adipose tissue response to surgical trauma. Surgery. 2013 Apr;153(4):584-93. doi: 10.1016/j.surg.2012.11.001. Epub 2012 Dec 27.
PubMed 23274098Mitchell JR, Beckman JA, Nguyen LL, Ozaki CK. Reducing elective vascular surgery perioperative risk with brief preoperative dietary restriction. Surgery. 2013 Apr;153(4):594-8. doi: 10.1016/j.surg.2012.09.007. Epub 2012 Dec 4.
PubMed 23218877
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Restriction in Vascular Surgery
- ClinicalTrials.gov ID
- NCT04013412
- Acronym / sponsor ID
- DRIVeS / 2018P002133
- Conditions
- Vascular Diseases, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. This study is a step in the long-term primary scientific objective to test the hypothesis that brief up regulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.
Detailed description
Hydrogen sulfide (H2S) has emerged as a critical gaseous signaling molecule with a role in multiple processes including ischemia-reperfusion (IR) injury, angiogenesis, intimal hyperplasia, and anti-inflammatory mechanisms. It even appears to hold anti-atherosclerotic properties. However, the gas is toxic with a half-life of minutes, and it can be rapidly oxidized. Furthermore, no clinically useful pharmacologic H2S donors have been developed to date. In a 2015 Cell paper, the study investigators link substantial upregulation of endogenous H2S to short-term manipulation of mammalian dietary intake: simple dietary restriction. The current project serves as the second phase in the accelerated translation of this important discovery toward clinical utility that may substantively impact the vascular patient at several levels: protection from IR injury, intimal hyperplasia, peri-procedural events such as stroke, cardiac dysfunction and myocardial infarction (MI), and promotion of angiogenesis.
Chronic protein and calorie dietary restriction (PCR; reduced food intake without malnutrition) is known for extending longevity in multiple species. PCR is also an established approach to positively impact metabolic fitness and resistance to multiple forms of acute stress. Despite these wide-ranging benefits, potential clinical applications have never been considered feasible in humans due to the practical difficulties associated with voluntary food restriction combined with the assumption that PCR benefits take a long time to accrue. Recent preclinical studies by the applicants reveal a rapid onset of PCR benefits against surgically induced traumatic inflammation, IR injury, and the fibroproliferative vascular response to injury in rodents. Mechanistically, rapid changes in adipose phenotype and associated adipokine profiles appear to underlie these benefits; but the key mediator appears to be endogenous H2S. This field thus stands poised to move to clinical utility, and vascular surgery offers an optimal risk/benefit ratio for translation of the PCR/H2S hypothesis.
For the current project the investigators will complete a randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative PCR diet in comparison to a normal ad libitum diet for 4 days before elective major vascular surgery. Both Endpoints relate to the long-term primary scientific objective to test the hypothesis that brief upregulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy titled Short-Term Endogenous Hydrogen Sulfide Upregulation (NCT03303534), the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.
Eighty subjects undergoing carotid artery endarterectomy, aortic aneurysm repair (open, and endovascular if groin cut down planned), open lower extremity arterial procedures (bypasses, aneurysm repair, arterial and bypass graft reconstructions), major amputation of the lower extremity (below knee and above knee amputations), or open hemodialysis access procedures for either symptomatic or asymptomatic disease will be recruited and enrolled at Brigham and Women's Hospital. Using a randomized (3:2), parallel design, patients will receive either the PCR diet (n=48; ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level), or continued routine ad libitum diet (n=32). Daily physical activity will be assessed by questionnaire to determine the activity factor for accurate calorie restriction calculations. Water intake is ad libitum for both cohorts, and both diets can be consumed throughout the day and night (except on the day of surgery). Patients will consume their assigned diets for the four days leading up to surgery until midnight the day of surgery when both cohorts will be fasted for the procedure (per standard clinical guidelines).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3:2 randomization to short-term protein calorie restriction diet versus regular meals prior to elective major vascular surgery
| Arm | Type | Receives |
|---|---|---|
| Protein-Calorie Restriction | Experimental | Dietary Supplement: Protein-Calorie RestrictionFour day dietary intervention immediately before surgery of ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level. |
| Control | No intervention | –Ad libitum diet for four days immediately before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients greater than 18 years old who present for one of the following elective procedures at Brigham and Women's Hospital
- Carotid artery endarterectomy
- Aortic/iliac aneurysm repair (open, and endovascular if groin cut down planned)
- Open lower extremity arterial procedures (bypasses, aneurysm repair, arterial and bypass graft reconstructions)
- Major amputation of the lower extremity (below knee and above knee amputations).
Key exclusion criteria (10 listed)
- Patient intolerance or allergy to any of the ingredients in the PCR diet
- Active infection
- Pregnancy
- Malnutrition, based on abnormally low serum albumin (lower than 3 g/dL)
- Uncontrolled diabetes (HgbA1c greater than 12%)
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 |
|---|---|---|
| Protein-Calorie RestrictionFour day dietary intervention immediately before surgery of ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level. | Dietary supplement | Protein-Calorie Restriction |
Primary outcome
Outpatient compliance with protein calorie restriction
Time frame: 1 Month
Patient compliance with the PCR diet will be assessed by food record analysis.
Comparison of H2S and related biological markers of stress
Time frame: 1 Month
Biologic markers include: adipose phenotyping (quantification of adipokines, adipose derived hormones), leukocyte phenotyping and quantification via flow cytometry, and serum assays of IL-1beta, IL-6, IL-8, HGF, leptin, MCP-1, PAI-1, resistin, NGF, TNF, adiponectin, hydrogen sulfide (including production capacity) assays, insulin, lipid panels, FGF 21, pre-albumin, epinephrine, norepinephrine, dopamine, CBC with differential, basic metabolic panel including calcium. H2S and biologic markers will be compared at baseline, immediately before surgery, and the day after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 28591635Hine C, Kim HJ, Zhu Y, Harputlugil E, Longchamp A, Matos MS, Ramadoss P, Bauerle K, Brace L, Asara JM, Ozaki CK, Cheng SY, Singha S, Ahn KH, Kimmelman A, Fisher FM, Pissios P, Withers DJ, Selman C, Wang R, Yen K, Longo VD, Cohen P, Bartke A, Kopchick JJ, Miller R, Hollenberg AN, Mitchell JR. Hypothalamic-Pituitary Axis Regulates Hydrogen Sulfide Production. Cell Metab. 2017 Jun 6;25(6):1320-1333.e5. doi: 10.1016/j.cmet.2017.05.003.
- Background: PubMed 28052287Longchamp A, Harputlugil E, Corpataux JM, Ozaki CK, Mitchell JR. Is Overnight Fasting before Surgery Too Much or Not Enough? How Basic Aging Research Can Guide Preoperative Nutritional Recommendations to Improve Surgical Outcomes: A Mini-Review. Gerontology. 2017;63(3):228-237. doi: 10.1159/000453109. Epub 2017 Jan 5.
- Background: PubMed 27386152Longchamp A, Tao M, Bartelt A, Ding K, Lynch L, Hine C, Corpataux JM, Kristal BS, Mitchell JR, Ozaki CK. Surgical injury induces local and distant adipose tissue browning. Adipocyte. 2015 Nov 20;5(2):163-74. doi: 10.1080/21623945.2015.1111971. eCollection 2016 Apr-Jun.
- Background: PubMed 26041674Robertson LT, Trevino-Villarreal JH, Mejia P, Grondin Y, Harputlugil E, Hine C, Vargas D, Zheng H, Ozaki CK, Kristal BS, Simpson SJ, Mitchell JR. Protein and Calorie Restriction Contribute Additively to Protection from Renal Ischemia Reperfusion Injury Partly via Leptin Reduction in Male Mice. J Nutr. 2015 Aug;145(8):1717-27. doi: 10.3945/jn.114.199380. Epub 2015 Jun 3.
- Background: PubMed 25542313Hine C, Harputlugil E, Zhang Y, Ruckenstuhl C, Lee BC, Brace L, Longchamp A, Trevino-Villarreal JH, Mejia P, Ozaki CK, Wang R, Gladyshev VN, Madeo F, Mair WB, Mitchell JR. Endogenous hydrogen sulfide production is essential for dietary restriction benefits. Cell. 2015 Jan 15;160(1-2):132-44. doi: 10.1016/j.cell.2014.11.048. Epub 2014 Dec 23.
- Background: PubMed 25124359Mauro CR, Tao M, Yu P, Trevino-Villerreal JH, Longchamp A, Kristal BS, Ozaki CK, Mitchell JR. Preoperative dietary restriction reduces intimal hyperplasia and protects from ischemia-reperfusion injury. J Vasc Surg. 2016 Feb;63(2):500-9.e1. doi: 10.1016/j.jvs.2014.07.004. Epub 2014 Aug 8.
- Background: PubMed 23274098Nguyen B, Tao M, Yu P, Mauro C, Seidman MA, Wang YE, Mitchell J, Ozaki CK. Preoperative diet impacts the adipose tissue response to surgical trauma. Surgery. 2013 Apr;153(4):584-93. doi: 10.1016/j.surg.2012.11.001. Epub 2012 Dec 27.
- Background: PubMed 23218877Mitchell JR, Beckman JA, Nguyen LL, Ozaki CK. Reducing elective vascular surgery perioperative risk with brief preoperative dietary restriction. Surgery. 2013 Apr;153(4):594-8. doi: 10.1016/j.surg.2012.09.007. Epub 2012 Dec 4.
- Individual participant dataSharing planned: No
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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.
Charles K Ozaki, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-Calorie Restriction in people with Vascular Diseases and Surgery, run by Brigham and Women's Hospital at 1 site 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 6 inclusion and 10 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Outpatient compliance with protein calorie restriction (time frame: 1 Month). The study lists 2 primary outcomes in all. 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 NCT04013412, which also lists 8 linked publications.
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 25 Sep 2020.