One of the challenges in this IRB process is that we don’t have a lot of latitude to give regular updates on it as it unfolds. Under most normal circumstances, aspects of the protocol draft and review, legal and liability considerations, and even the stages of approval are kept quiet until formal announcement and start of the study.
With that said, I’m quite confident we’re on the last step of this process. There are quite a few things on our long checklist with the IRB, and right now we’re on the last one. Hopefully we’ll have some news very soon.
I wanted to give a quick heads up to all our wonderful supporters that the process for the IRB is currently in progress. There’s quite a lot of moving parts to this study, although you only really understand that once you’re into this end of the pool, as it were. Moreover, there’s a number of things we’re asking for that are unusual, but I can’t discuss this until we’re closer to approval.
Regardless, while we can’t give any estimates as to when this key phase will be completed, I do feel very optimistic that we’re getting close. Once we are fully approved, we can then begin the recruitment process. Keep your eyes on this space for that announcement when we’re ready.
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.
Travel
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
Genetic Testing
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:
Will someone with an LDL-C of 300 mg/dL (with concordant apoB) due to LCHF develop atherosclerosis faster than the same person all else being equal with an LDL-C of 100 mg/dL (concordant apoB).
All else is normal. Active. Great blood pressure. Low insulin. Low CRP etc in both.
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.
We’re pleased to announce a debate for charity between Dr. Tro Kalayjian (“Dr. Tro”) and Layne Norton, PhD (“Biolayne”). They will be discussing current nutrition controversies:
Is sugar harmful?
Can restrictive diets cause eating disorders?
Do diets such as low carb and low fat generally work the same way?
The debate will be recorded on Friday, September 25th and will be moderated by Dave Feldman
Once completed, it will be co-broadcasted by both participants
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.
And for what it is worth, we’re very close now to our funding goal. As of this writing, we have raised $82,185 and thus need a little less than $17,815 to “close the gap” to reach $100,000. At that point we have an anonymous donor who has committed to matching that full amount to bring us to $200,000 total.
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.
