Our Principal Investigator, Dr. Matthew Budoff has now presented the matched analysis for: The KETO (#LMHRstudy) vs Control (#MiHeart) cohorts.
Watch full presentation along with follow up Q & A here:
METHODS – 80 Participants of #LMHRstudy fell within #MiHeart age range and were then matched 1:1 for age, gender, race, diabetes mellitus, hyperlipidemia, hypertension, and past smoking to asymptomatic subjects from the #MiHeart cohort.
PRIMARY ANALYSIS – High resolution heart scans (#CCTA) allowing for primary analysis of Total Plaque Score (TPS), Total Stenosis Score (TSS) and Segment Involvement Score (SIS)
RESULTS The matched mean age was 55.5 years, with mean #LDL cholesterol of 272 mg/dL (max LDL-C 591) mg/dl and mean 4.7 years duration on a ketogenic diet.
There was no significant difference in coronary plaque burden of #LMHRstudy (mean LDL-C 272) cohort as compared to #MiHeart controls (mean LDL 123 mg/dl); nb: pre-KETO LDL-C in KETO group was 122 mg/dl
There was no significant difference in CAC (median and IQR) [0 (0,56)] versus [1 (0, 49)], p = 0.520
No relationship of LDL-C elevations and plaque
This analysis is on baseline scans and the study is still ongoing for second CCTA completion in our cohort by February of 2024. As always, please continue to work with your doctor.
Dr. Budoff will be presenting a new CTA comparison analysis on this cohort against a matched control from the Miami Heart Study (MiHeart). The MiHeart cohort has been closely matched for demographics and risk factors, save LDL cholesterol levels, which average less than half of the Keto-CTA cohort.
While the LMHR study continues to completion, we’ll be initiating this companion study to run in parallel. It will have much in common with the current LMHR Study save a few key differences:
Control group – We’ll be recruiting a control group for comparison.
More relaxed criteria – We will likely have a more permissive risk profile, such as allowing lower HDL cholesterol and higher triglycerides.
Possibly multicenter – This may be conducted across multiple research facilities over a number of major cities, which would make it a bit easier for scheduling and travel on participants.
The good news – operationally, this should be much, much easier the second time around
Our organization, the Citizen Science Foundation, is already built – a bona fide 501(c)(3) Public Charity – with a 0% admin overhead (save third party services like credit card fee %, hosting, etc)
We already have a relationship with The Lundquist Institute.
We’ve already had IRB approval with the LMHR Study – and this time around, we’ll have specific data on safety consideration for a new approval.
We already have contact information in the hundreds for people who just barely didn’t meet the eligibility of our LMHR study – but who may meet these more relaxed criteria.
However, financially, this will necessarily cost more if we’re including a control group
Given all our meetings in the last several months, we place the ballpark cost per visit at $1,500 – for a total of two visits, thus $3,000 per participant.
I’m hoping our minimum raised will give us enough for 40 in each group, which would be around 80 x $3,000 = $240,000.
But… while that might be closer to our minimum, I’d love if we could actually reach 100 in each group as a stretch goal.
Thankfully, we have $100,000 in matched donations to kick us off
An anonymous donor has come forward to match up to $100,000 of donations coming in for this project. So everyone who contributes to this study endeavor will be matched, dollar for dollar, until we reach that goal.
Consider contributing below, and remember the CSF is a Public Charity, so your donation is tax deductible. As always, thank you for your support!
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!