I’m pleased to announce we have now submitted our completed protocol to the IRB committee for review.
During the review process there may be additional revisions to the protocol before we get final approval. Once approval is finalized, we can launch the study and begin recruitment.
Please be aware the timing on when we get this approval is difficult to predict. It can take days, weeks, or even months in some cases. If interested in participating, please be patient and continue checking back as we’ll announce widely (and loudly) when recruitment has officially begun here at CitizenScienceFoundation.org, CholesterolCode.com, and across social media.
After a year of planning, fundraising, and intense coordination, we’re proud to announce our study design is now being powered by our biostatistician as the last step before submitted to the IRB committee for evaluation.
Once approved, we will begin the process of recruiting participants for the study. When that stage arrives, we’ll be announcing it on the Citizen Science Foundation website and across social media.
We managed to get the center we wanted to do the study and will be announcing it when the IRB is approved. This study would have cost several times the $200,000 we raised, but I’m pleased to say we worked out getting the price down to this budget, particularly given our mutual interest in the data.
However, this does present us one more stage of fundraising we’ll need to complete: travel, and genetic testing.
All the participants will need to be flown to the city of the study, be taxied to their hotel room, stay overnight to be fully fasted and relaxed for their testing in the morning, taxied back to the airport afterwards, and then flown out on the return trip. And this needs to happen twice for each participant, one for the baseline test, and in a second round a year later for the followup.
We believe we can negotiate these expenses in a bulk package deal with the airline, hotel and ride sharing services to get this down to around $250 per visit of our 100 participants, for a total of $50,000
Secondly, we need to raise funds for genetic screening so we can ensure no one in the experiment with high cholesterol has this due to an underlying condition, such as familial hypercholesterolemia. We estimate the cost for this to be around $100 for each of our 100 participants, for a total of $10,000.
Thus, we need to raise another $60,000.
But get this – we already have an anonymous donor who has offered to match half of it. So really, we just need to raise $30,000.
And that’s where you come in — you can show your commitment in two important ways. Contribute to CitizenScienceFoundation.org, and/or please share this video to help us reach this critical milestone so we can launch the study when our IRB approval comes back.
One of our investigators, Spencer Nadolsky put out this tweet poll recently:
Clearly this a very controversial question that we’re looking to get answers to. As explained in our video outline for the study*, there is a phenotype in the low carb community that has extremely high LDL-C, yet often has all other cardiovascular risk markers at optimal levels.
Like Dr. Nadolsky, many believe they may be at severe risk given high LDL alone. And indeed, there’s a lot of literature that associates high LDL-C with cardiovascular disease in those with familiar hypercholesterolemia. If these same individuals have a comparable level of LDL-C induced by diet – will it convey the same risk?
We aim to find out.
Help us gather this critical data by showing your support today.
The pandemic brought on by COVID-19 has had a substantially impact on all our lives in many ways. Like so many others, we’ve been adapting to a new normal that includes substantially more uncertainty. These are indeed challenging days.
With that said, it’s time again to press forward.
Tommy Wood, Spencer Nadolsky, and myself have had a series of meetings in preparation for the next steps of the LMHR study with IRB submission. We are also coordinating with potential locations for our testing. Yes, the current crisis may further offset scheduling and/or create other unanticipated hurdles, but we are very committed to getting this study executed.
As per my message before, I know these are difficult times and I fully expect everyone to take care of themselves and their family’s needs throughout this pandemic. In other words, don’t give what you can’t give easily.
I’m very pleased to announce we now have official designation from the Department of Treasury as a 501(c)(3) Public Charity.
The Effective Date of Exemption is October 23, 2019, which precedes all donations made (the foundation was announced after that date). Thus, if you’ve made any donation to the Citizen Science Foundation now or previously, it will meet this exemption status. Please consult your tax preparer for further details.
I realize this news comes at an unusual time given the COVID-19 pandemic. As mentioned before, we’d expect everyone to take care of themselves and their family at this difficult time — don’t give what you can’t give, of course. But with that said, we’re still very much moving forward, even if briefly slowed down by this crisis, and I’m beyond ecstatic this designation will help further pave the way.
I want to give you some important updates on the Citizen Science Foundation, the LMHR project, and possible impacts with the coronavirus pandemic.
Firstly, I was incredibly excited in February when we got confirmation the CSF would be moving from a private foundation to a public charity. We’re actively in contact with the IRS to make this change as the response and support from so many of you have taken us to the next level.
Second, while I wasn’t able to announce it publicly before, I can now confirm that we are indeed looking to convert the Lean Mass Hyper responder project to a formal study. Not only are we in the process of preparing for review with an IRB for approval, but we’re excited to be partnering with a very senior researcher and their team to execute this groundbreaking study.
While much of this news was confirmed near the end of February, I’ve held off discussing it until we could gain greater certainty on how the emerging pandemic of covid-19 might affect the timing of our study. As I’ve mentioned many times before, we were hoping to have this project launching in the summer, but of course, that timing is less certain right now.
Regardless, I can assure everyone that — outside of processing fees — every single penny collected from your generous contributions will remain entirely untouched. It’s earmarked strictly for this project. We have no administrative contractors or employees, and all business expenses for the foundation are paid solely by me.
The anonymous donor who will be matching a $100,000 is still very much dedicated to doing so when we close the final gap of $24,000, which we will do. But for now, I will not be doing any active fundraising. While we are still accepting donations and will continue to do so, I certainly expect everyone will first look after their family and wellbeing in these challenging times.
In the mean time, rest assured nothing will stop us from making this study happen. There’s no question of if, just when.
Spencer Nadolsky, Tommy Wood, and I have been having a series of meetings regarding the next major phase, which will soon result in an announcement to come. Please stay tuned as we hope to have it ready in the coming weeks.
We have some powerful news today – we now have it on strong authority that the followup time for the LMHR Measurement Project will be more than sufficient at one year, not five.
Spencer, Tommy, and I have been consulting many people both individually and together, including a very high level imaging expert. And we’re now confident progression of atherosclerosis for the LMHR population should be observable with CT Angiogram imaging at one year apart.
Needless to say, this is some very unexpected news. But I’d argue it is certainly more positive than negative. This does introduce a new slate of changes we’ll need to adjust for:
Our existing budgetary timing will be tighter. We have been seeking $2,000 per LMHR for this initial round of tests with the assumption we’d be raising the same amount for the second round in five years time. Given we’re now talking one year, the turnaround time will need to be much sooner.
However, with regard to (1) above, our high level expert has helped us figure out ways to save on the overhead per participant, but we can’t speak on that just yet. We now think we may be able to still keep the price to $2,000/each, but manage to cover both the first and second round testing.
This may change my own plans for the documentary and book. Given how close we are to having data in hand, it may be worth chronicling the effort in real time until it is wrapped, thus having a more compelling story for each medium given the big ending.
It’s pretty hard to express in words how seismic this news has been for us. Instead of a long stretch for half a decade once we break ground, we could instead be bringing forward powerful new data in just a twelve months regarding diet-induced high cholesterol and risk of atherosclerosis.