I wanted to let you know we’ve had an extraordinary development.
On February 8th, the Lundquist Institute completed the first visit scans of all 100 participants for the LMHR study. On the 17th Dr. Budoff presented me with the generalized preliminary data to determine if we should publish a preliminary paper. To say this data was compelling would be an understatement.
We’re now moving forward with publication of a preliminary paper as soon as possible. We’re very confident this will be both novel and of enormous interest, particularly in the low carb community.
Importantly, this has completely changed our roadmap for a future study. Originally, we were going to wait until completion of the LMHR study to consider if we should do a confirmatory study. However, this new data not only confirms for me that we should move forward with a new study – I believe we should get started on developing it without delay. We can easily run it concurrently with the LMHR study, each through the Lundquist Institute.
This is all I can report for the moment as each of these endeavors are in development. But hopefully I’ll be able to provide more details on both the preliminary paper and the companion study design over the coming weeks.
Once again, thank you all for your extraordinary support.
Again, each of our 100 participants will make a total of two trips to the Lundquist Institute. The first will provide the baseline scan, then they will return a year later for their second scan. Once all participants have completed both scans, we’ll move ahead with the final analysis.
We’re still in the process of completing our funding for this study as travel costs have proven more challenging in the current economic environment. Again, thanks to everyone for all their support!
We’re very excited about the Lean Mass Hyper-Responder Study, but the endeavor is ongoing and we’re still not fully funded due to the recent economic developments.
Our study design makes use of round trip flights, overnight lodging, and car services to bring participants to Lundquist Institute for advanced bloodwork and scanning while fully rested and properly fasted. Needless to say, these cost projections have gone up substantially throughout 2022 and we are in need further support.
Please consider contributing to help us complete our funding.
We are a fully qualified 501(c)(3) Public Charity making your donation tax deductible (check with your tax preparer for details). And, of course, you’ll be helping us making a crucial advancement that simply wouldn’t happen without individual contributions like yours.
We’re excited to announce our special edition Commemorative Magnetic Pin for the Keto Orlando Summit.
You can order the pin for a minimum donation of $25 and we’ll ship it to you in celebration of this amazing conference in collaboration with Citizen Science.
All proceeds from pin purchases go directly to the Citizen Science Foundation, so you not only get the first-ever limited edition Citizen Science Foundation memorabilia you also support projects like The Lean Mass Hyper-responder study with each purchase.
If you are not attending the conference, or attending virtually — no problem as we’ll ship your pin to the address you provide for the donation
If you are attending in person, I (Dave Feldman) will be coming as well and can hand you your pin while you’re there — as well as thank you for your support!
The Lipid Energy Model (LEM) examines the phenomenon of rising cholesterol levels for those on low carbohydrate diets and how this may provide powerful insights into lipid metabolism overall.
The LEM provides a mechanistic explanation for:
The Lean Mass Hyper-Responder (LMHR) phenotype, characterized by the triad of high LDL (at or above 200 mg/dL), high HDL (at or above 80 mg/dL or above), and low triglycerides (at or below 70 mg/dL), as well as for
The phenomenon that LDL-C change on low-carbohydrate diets tends to associate inversely with BMI.
The LMHR phenotype and observation that leaner people with better metabolic health markers are possibly at greater likelihood for increases in LDL-C were described in our prior observational cohort study: https://doi.org/10.1093/cdn/nzab144.
As a personal aside from the first and last authors (Nick Norwitz and Dave Feldman), while we’ve longed looked forward to this milestone, we wish to note that this is just the first of many. Interest in LMHR continues to grow, not only within the low-carb community, but within academic medicine. The publication of the LEM hypothesis paper is a landmark, not because it provides a comprehensive theory with rigorous support from human trials assessing the model, but because it presents a concrete hypothesis with direct and testable predictions.
It is our hope that the publication of the LEM paper (version 1.0) will encourage fellow researcher to help us test these ideas in interventional trials and, thereby, advance scientific knowledge regarding LMHR and, perhaps, human lipid metabolism more broadly.
We’re happy to announce the release of our new LMHR Case Study this week in Frontiers in Endocrinology. Feel free to download the PDF and share the page link if you find the paper compelling. (The more our work is shared, the more it supports our efforts, of course.)
Highlights of the new paper:
LDL-C increased from 95 to 545 mg/dL at its peek
Keto diet is “Mediterranean” style with >4:1 unsaturated to saturated fat ratio
No genetic abnormalities found to explain phenotype
No detectable plaque in CT Angiogram after 2.5 years of followup
Just an important reminder we’re still actively recruiting for the Lean Mass Hyper-responder Study.
Please visit our official page for the study here and see if you meet the major eligibility requirements. If so, reach out to Lundquist with their contact information at the bottom of the page.
And thanks again for everyone who is joining us for the incredible endeavor!
We’ve been quite proud of how well we’ve set up efficient budgeting with our research partners for this important study. Lundquist and our bloodwork providers are giving us strong discounts along with Keto Mojo and GB HealthWatch completely contributing their products and services.
Unfortunately, there’s one area of cost we don’t have much control over: travel and lodging.
Rising Costs for Travel, Participants
At the time we were building our projected expenses, it seemed likely we could negotiate packages between plane, car service, and hotel coming in around $250 combined per person, per trip. And to be fair, that was pretty realistic in December 2020 when travel industries were struggling, which was when we published this video.
However, the IRB process didn’t happen in short time as we’d hoped. We weren’t fully approved until August of 2021 when I announced the study launch. Unsurprisingly, as travel across the nation has resumed in those nine months, prices for all these travel services have increased, which is where we are now.
There have been a handful of other expenses that were unanticipated. One of our bloodwork partners has required us to set up a specialized account for clinical trials that involves greater expense. Another overseas bloodwork partner needs samples shipped as frozen throughout the trip, which costs quite a bit. And we did add a $50 meal voucher per trip for participants as recommended strongly by our research partners to accommodate their stay.
All together, we believe we’ll need to raise an additional $97,000.
OwnYourLabs.com Contribution
The good news is that our other venture, OwnYourLabs.com, has been accumulating proceeds throughout 2021 to contribute directly to the Citizen Science Foundation. I’m pleased to announce this totals $51,000, thus cutting the amount we need to raise to $46,000.
(And also, props to each and every one of you who bought your labs through OwnYourLabs.com as all of them contributed directly to this study!)
How You Can Help
There are three primary ways you can show your support:
Contribute directly to the Citizen Science Foundation. Again, we are a fully qualified, 501(c)(3) Public Charity. Naturally, this is the easiest and most direct way to help. The contribution is generally tax deductible – please talk to your tax preparer for more details. It’s worth noting we have a 0% admin overhead, save third party services (such as credit card processing).
Order your private bloodwork through OwnYourLabs.com. Proceeds are continuing to accumulate for further funding directly to the CSF to support this study. Moreover, if you opt in, you can further help citizen science by volunteering your anonymized data for a discount (see site for details).
Share, retweet, repost – spread the word! Obviously, the more you can help us let others know about this important cause, the better. 🙂
