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L-Theanine Experiment (1 Month)

doubleblinded.com

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Re: L-Theanine Experiment (1 Month)

#51
post #15

I tried taking L-Theanine for about 5 days. 30 minutes after taking it each day, I would get very nauseous and usually throw up. I tried varying the dosage from 200mg down to 100mg and then 75mg, I would still get the nausea, no matter if I had an empty stomach or not. I also get the same symptom when drinking more than a cup or so of green tea, and has for years (though I do remember being able to stomach the stuff…

I get the same effect from drinking Starbuck's "Awake" or black tea, whatever they call it now. An empty stomach usually makes it worse.

I got side effects from some medication I took until one day I was about to take them and then forgot, still got the side effects, and finally found I hadn't taken the meds after all.

At that time I concluded it was all nocebo and the side effects were almost completely gone from that day on.

Re: L-Theanine Experiment (1 Month)

#52
post #23

This website almost certainly violates FDA rules on human subject experimentation because it collects data on the effect of a drug on human subjects. I would stop working on this project until you have advisors (and lawyers) who have experience with regulatory oversight from the FDA. At the bare minimum you are going to need (a) procedures to gain informed consent from trial enrollees and (b) an Institutional Review…

Thanks for the thoughts. We've spoken with a lawyer who specializes in FDA issues. We will have informed consent waivers for participants. Rob does have formal training in scientific ethical issues and is more than competent on the subject. Also, L-Theanine is something that you can purchase at the grocery store as a food supplement and it has an excellent safety record and no known toxic dosage. If it makes you feel…

>If it makes you feel better, we are a supplement distributor that happens to help you record whether or not the supplements actually work.

From your website:

>we want to make this clear: we are not a supplement company. We are a personal experimentation platform.

That being said, I actually like your idea. You just need to be more careful about choosing a message (and staying on message).

Re: L-Theanine Experiment (1 Month)

#53
post #13

I love the idea, but the execution seems less than ideal. Besides the research ethics question posed in another comment, what is the dosage of L-Theanine in the capsules? What kind of responsibility does the company take for possible side effects? I understand the side effects should be mild or non-existant in the experiment for L-Theanine, but just a discussion around that issue would be nice. Again, I want to stres…

And, if you're repackaging the supplement in capsules, do you need to be operating under whatever equivalent the supplement industry has to GMP conditions?

Re: L-Theanine Experiment (1 Month)

#54

Earlier quoted context omitted.

We make no medical claims about our product either - we only reference existing science.

"[...] and is known to promote relaxation without sedation. It appears to be effective at this as well as reducing stress at standard dosages." I would read that as a medical claim, it doesn't matter if you quote another site or not. The claim about stress seems to be based on experiments in rats and a single study with 12 participants.

This made me curious so I checked the FDA site. In case anyone else is interested:

From a very cursory review, it appears that health claims on the packaging are quite heavily regulated by the FDA[1], but advertising for dietary supplements and foods seems to fall outside their mandate and regulatory responsibility lies instead with the FTC:

"The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws."[2]

I'm not sure what's on the bottle, but presumably the websites falls under the jurisdiction of the FTC. A brief review of their site seems to indicate a far more relaxed approach is taken. For example:

"The FTC's standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of science"

"These factors are often weighed together to ensure that valuable product information is not withheld from consumers because the cost of developing substantiation is prohibitive"

"...the FTC gives great weight to accepted norms in the relevant fields of research and consults with experts from a wide variety of disciplines, including those with experience in botanicals and traditional medicines" [3]

[1] http://www.fda.gov/Food/IngredientsPackagingLabeling/Labelin...

[2] http://www.fda.gov/Food/DietarySupplements/QADietarySuppleme...

[3] https://www.ftc.gov/tips-advice/business-center/guidance/die...

Re: L-Theanine Experiment (1 Month)

#55

Earlier quoted context omitted.

Thanks for the thoughts. We've spoken with a lawyer who specializes in FDA issues. We will have informed consent waivers for participants. Rob does have formal training in scientific ethical issues and is more than competent on the subject. Also, L-Theanine is something that you can purchase at the grocery store as a food supplement and it has an excellent safety record and no known toxic dosage. If it makes you feel…

The other comments are on point. From my perspective as someone in the digital health / clinical research industry, the site (as is) raises a bunch of red flags: - There's no indication this study has received IRB (Institutional Review Board) approval, which is a baseline. Here's a handy reference when asking the question, "Does my research need IRB approval?": http://www.irb.umn.edu/research.html Based on several fa…

This is an incredibly informative and useful post. Thank you.

Re: L-Theanine Experiment (1 Month)

#56

Earlier quoted context omitted.

The other comments are on point. From my perspective as someone in the digital health / clinical research industry, the site (as is) raises a bunch of red flags: - There's no indication this study has received IRB (Institutional Review Board) approval, which is a baseline. Here's a handy reference when asking the question, "Does my research need IRB approval?": http://www.irb.umn.edu/research.html Based on several fa…

This is an incredibly informative and useful post. Thank you.

Thanks! Digital health can be incredibly fun and rewarding, but there are plenty of opportunities to run head first into walls you may not have realized even existed.

Aside from the ethics considerations, privacy regulations (and the desire to tread conservatively) can lead to some odd implementation decisions...especially if you're coming into the industry from a general or consumer oriented tech background.

I once worked on a medication adherence project for patients in Italy where patients needed to complete bi-weekly assessments and generally track their medication adherence. We set up a secure portal/website for patients, but were prohibited from emailing them reminders when their next assessment was due.

The sponsor (aka pharma co) was extremely conservative re: patient privacy laws and more or less left it at, "well, the patient will just have to remember to return to the website, log in, and complete their survey at the appointed time." After a couple of months of sub-optimal survey completion rates, they re-evaluated their position and let us send out survey reminder emails.....which is a baseline thing to do when you need to retain participants over the life of a study.

Oddly enough, this was for a commercial project (medication was available on the market, physicians were referring their patients to this website as a value added sort of service) and the commercial side is a bit more wild west than phase 2/3 research. Well, as wild west as the pharma/clinical research industry gets :)

There are parallels between customer acquisition/retention in SaaS and patient recruitment/retention in clinical trials that are pretty interesting...but I think most folks on the Saas side would think the healthcare folks are trying to solve problems with one (if not two) hands tied behind their backs - and in some cases, wouldn't be wrong in thinking so.

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