Travel Cost Challenges

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.

Thank you!

Sincerely,
Dave Feldman

Limited Edition Magnetic Pin for the Keto Orlando Summit

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!

Lipid Energy Model Published

We’re excited to announce the publication of the Lipid Energy Model in Metabolites.

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.

We have also recently provided a particularly comprehensive clinical vignette of an LMHR: https://doi.org/10.3389/fendo.2022.830325

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.

New LMHR Case Study Published

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

Our video abstract here (7 minutes):

Help Us Raise $46,000 for the LMHR Study

Hello everyone and Happy New Year!

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. 🙂

New Paper – Elevated LDL-Cholesterol with a Carbohydrate-Restricted Diet: Evidence for a ‘Lean Mass Hyper-Responder’ Phenotype

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A new paper in published via Current Developments in Nutrition analyzes data regarding cholesterol and carb restricted diets.

Highlights:

  • Increased LDL-C on Low Carb Diets strongly associate with leanness (low BMI) and low triglyceride/HDL-C ratio
  • Modest intervention of added carbs reduced LDL-C in case series
  • Further analysis of “Lean Mass Hyper-responder” subcategory

doi.org/10.1093/cdn/nzab144

One Last Step

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.

IRB Progress Update – Taking Time, But Getting There

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.