Coronary Artery DiseaseNCT04150159
Evaluation of a Fasting Mimicking Diet
A study testing FMD Arm in people with Coronary Artery Disease, run by Hypertension Institute, Nashville at 1 site in United States.
Trial summary
Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FMD Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Jan 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index equal to or greater than 28
- EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.0.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
- Pregnant females
- Any cancer within the past 5 years
- Documented myocardial infarction within past 5 years
- Documented cerebrovascular accident within past 5 years
- Chronic steroid use (longer than 45 consecutive days
- Type I insulin-dependent diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers
Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.
Read the detailed description
Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure, serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing for endothelial function, arterial stiffness of large and small arteries and autonomic function testing in adult subjects over a seven-month study period.
- Conditions
- Coronary Artery Disease
- Being tested
- FMD Arm
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMD ArmDietary supplement
ProLon Fasting Mimicking Diet Plan
| Study group | Role | What they receive |
|---|---|---|
| Fasting Mimicking Diet (FMD) Arm | Experimental | The ProLon® FMD diet is made up of nut bars, dehydrated soups, tea, olives, kale crackers, electrolyte beverages, and a chocolate crisp bar consumed for 5 days every 30 days for 4 months. Receives: Dietary Supplement: FMD Arm |
| Mediterranean Diet Arm | Active comparator | The Mediterranean diet is based on the traditional foods that people used to eat in countries like Italy and Greece in the 1960s.
* Eat every day: vegetables, fruits, nuts, seeds, legumes, potatoes, whole grains, breads, yogurt, dairy, fish/seafood, herbs, spices and extra virgin olive oil.
* Eat three or fewer servings each week: poultry, eggs, cheese.
* Eat two or fewer servings each week: red meat, potatoes.
* Eat two or fewer servings each week: sweets, sodas, processed meat, refined grains, refined oils and other highly processed foods. Receives: Dietary Supplement: FMD Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to End of Study in endothelial function
Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers
Measured: 7 months
Secondary outcomes (1)
Change from Baseline to End of Study in cardiovascular biomarkers
Cardiovascular biomarkers will be measured for all subjects with serum lipid levels and serum inflammatory markers
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Mar 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- This is a randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hypertension Institute, Nashville
- Sponsor type
- University, hospital or other
- Collaborators
- L-Nutra Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150159
- Sponsor's protocol ID
- HTI 001
- Status last verified
- Jul 2020
- First submitted
- 25 Oct 2019
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandhorst S, Levine ME, Wei M, Shelehchi M, Morgan TE, Nayak KS, Dorff T, Hong K, Crimmins EM, Cohen P, Longo VD. Fasting-mimicking diet causes hepatic and blood markers changes indicating reduced biological age and disease risk. Nat Commun. 2024 Feb 20;15(1):1309. doi: 10.1038/s41467-024-45260-9.
PubMed 38378685
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers
- ClinicalTrials.gov ID
- NCT04150159
- Acronym / sponsor ID
- HTI 001
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hypertension Institute, NashvilleUniversity, hospital or other
- Collaborators
- L-Nutra Inc
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 4 Nov 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.
Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.
Detailed description
Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure, serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing for endothelial function, arterial stiffness of large and small arteries and autonomic function testing in adult subjects over a seven-month study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months.
| Arm | Type | Receives |
|---|---|---|
| Fasting Mimicking Diet (FMD) Arm | Experimental | Dietary Supplement: FMD ArmThe ProLon® FMD diet is made up of nut bars, dehydrated soups, tea, olives, kale crackers, electrolyte beverages, and a chocolate crisp bar consumed for 5 days every 30 days for 4 months. |
| Mediterranean Diet Arm | Active comparator | Dietary Supplement: FMD ArmThe Mediterranean diet is based on the traditional foods that people used to eat in countries like Italy and Greece in the 1960s. * Eat every day: vegetables, fruits, nuts, seeds, legumes, potatoes, whole grains, breads, yogurt, dairy, fish/seafood, herbs, spices and extra virgin olive oil. * Eat three or fewer servings each week: poultry, eggs, cheese. * Eat two or fewer servings each week: red meat, potatoes. * Eat two or fewer servings each week: sweets, sodas, processed meat, refined grains, refined oils and other highly processed foods. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index equal to or greater than 28
- EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.0.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (7 listed)
- Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
- Pregnant females
- Any cancer within the past 5 years
- Documented myocardial infarction within past 5 years
- Documented cerebrovascular accident within past 5 years
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 |
|---|---|---|
| FMD ArmProLon Fasting Mimicking Diet Plan | Dietary supplement | Fasting Mimicking Diet (FMD) Arm, Mediterranean Diet Arm |
Primary outcome
Change from Baseline to End of Study in endothelial function
Time frame: 7 months
Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers
1 secondary outcome
Change from Baseline to End of Study in cardiovascular biomarkers
Time frame: 7 months
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 31 Jul 2020.
- Derived from this study: PubMed 38378685Brandhorst S, Levine ME, Wei M, Shelehchi M, Morgan TE, Nayak KS, Dorff T, Hong K, Crimmins EM, Cohen P, Longo VD. Fasting-mimicking diet causes hepatic and blood markers changes indicating reduced biological age and disease risk. Nat Commun. 2024 Feb 20;15(1):1309. doi: 10.1038/s41467-024-45260-9.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMD Arm in people with Coronary Artery Disease, run by Hypertension Institute, Nashville 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 3 inclusion and 7 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 31 Jul 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?
Change from Baseline to End of Study in endothelial function (time frame: 7 months). 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 NCT04150159, which also lists 1 linked publication.
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 31 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.