7 ms·

L-Theanine Experiment (1 Month)

57 points by chrisrxth 11y ago

OopsCriticality 11y ago
Yikes! I'm a bit disappointed and slightly surprised that there's no discussion nor consideration of research ethics appearing anywhere on that website.
- chrisrxth 11y ago
  You bring up a good point! We will be adding some outlines about ethics soon. Thanks for reminding us of the importance!
  - robbiep 11y ago
    I'm sorry, you have a website called doubleblind, you are asking people to pay to participate in the study, and you need to be reminded of the importance of thinking about ethics? There's a reason why science and medicine don't move the same way Web 2.0 does (ie move quickly and break things). It's because people have died from poor implementations, and people trialing drugs are prone to exploitation from unscrupulous merchants. Now I'm not saying there's anything wrong with your study, or your proposed aims. But if you want to be taken seriously and not shut down by whatever regulatory authority governs your territory, you need to think long and hard about this on both this study and any future studies/products you intend to sell. Do not screw this up, and do not make the mistake of approaching human health and clinical trials as though something critical like ethics review is something that can be 'patched' further down the line after the release date
    - chrisrxth 11y ago
      We chose L-Theanine because it has an excellent safety record, is well studied, and has no known toxic dose. We are very aware of safety and ethics. There are many nootropics and supplement companies safely distributing the same L-Theanine. While we work through our protocol we will continue to dive into ethics and safety.
      - robbiep 11y ago
        What you have stated here you have stated in your previous thread announcing doubleblind and presumably elsewhere. I don't have an issue with what you are choosing, or why. In fact, it doesn't really matter. What matters is that you have a clear and transparent ethics approval process, that you clearly state the steps your protocol had been through, and preferably that you submit your protocol to a human ethics review board, and identify that process openly and transparently. It sounds like you have already developed your protocol, since you are offering your product for sale shipping from the start of this month. So have you written an ethics proposal? Have you considered submitting it to a HERC? Or are you 'continuing to dive into ethics and safety' now that you have been 'reminded of the importance' of it? Don't get me wrong, I think your idea and platform is potentially great. But it really seems that you haven't thought about this, and now you're trying to scramble? If you don't have a science background and aren't partnering with anyone who is, I'd be more than happy to lend my 2c outside of this thread (see profile). Otherwise, I wish you every success with a full and detailed examination of your ethics approach. Medical research (which you are conducting by calling your product an experiment) has a poor history when it comes to blurring the lines between researcher and pharmaceutical company/monetisation, of which you could be said to be doing both at the moment.
      - ska 11y ago
        While we work through our protocol we will continue to dive into ethics and safety. This part, for what it's worth, is ass backwards.
      - xenophonf 11y ago
        [L-Theanine] has no known toxic dose. You keep saying this like it means something. Even _water_ has a toxic dose: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770067/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770067/ It really makes me wonder whether you have adequate human subject protections in place or if you just hand-waved those away by assuming L-Theanine was completely safe.
    - deleted 11y ago
      [deleted]
  - OopsCriticality 11y ago
    Research ethics must be a central concern, not something hand-waved away with an outline at a later date. Maybe I'm getting a bad impression from your current website and comments, but appearances matter. The stereotypical "move fast and break things" attitude is wholly inappropriate here; human and animal research must be conducted with careful consideration and respect.
geoffwoo 11y ago
cool concept. interested in seeing the results.
nicw 11y ago
Looks promising. While it may seem obvious, I would spell out what double-blind means, the problem it solves, and how it is used elsewhere. That then sets you up to point out how doctors use these study types, adding credibility.
Lewton 11y ago
I absolutely love this idea. Are you gonna do a trial every month? Any schedule for which trials you're gonna run?
- chrisrxth 11y ago
  We're going to keep adding more trials - but there's no timeframe for when you have to start and end the trial. You can order it and start it whenever you receive it in the mail.
Robadob 11y ago
Interesting concept, shame it's limited to the US (understandable due to dubious legality of shipping unclassified chemicals between jurisdictions). Been interested by the apparent 'attention enhancing' qualities of L-Theanine, although not gone as far as purchasing any. By coincidence someone got me into drinking green tea a couple of weeks ago, I haven't noticed any visible change. Although I expect my problem is concentrating on the right thing, rather than simply failing to concentrate.
- arsenico 11y ago
  From my personal experience, L-Theanine, coupled with caffeine, produces very serious results in terms of negating bad coffee effects, increased focus and productivity, and better sleep
  - Legogris 11y ago
    Same here. A couple of pots of strong sencha (Japanese green tea) give me a huge boost in energy and mood, without the negative effects of derealization, tunnel vision and restlessness I get from too much coffee.
deleted 11y ago
[deleted]
dbcooper 11y ago
How do you propose to analyse the data you collect?
- doobiedowner 11y ago
  I'm guessing that they're more interested in the collected cash. It's all about the chee$e!
detaro 11y ago
Show HN when the idea was presented: https://news.ycombinator.com/item?id=10401698 https://news.ycombinator.com/item?id=10401698
Steer 11y ago
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 stress that I love the idea, but the web site just feels incomplete.
- vox_mollis 11y ago
  What kind of responsibility does the company take for possible side effects? Probably the same kind of responsibility taken by green tea manufacturers.
  - Steer 11y ago
    Fair enough. My impression was that this was the first of many similar experiments, but with different substances making my question perhaps more valid somewhere down the line.
    - chrisrxth 11y ago
      This is the idea - we'll have to address the safety and ethical concerns of each substance individually.
  - DanBC 11y ago
    Green tea sellers don't make medical claims for their products; green tea sellers don't enroll people in "research".
    - chrisrxth 11y ago
      We make no medical claims about our product either - we only reference existing science.
      - 11y ago
matt504 11y ago
Maybe this actually part of a study to research whether having your research subjects pay you (rather than the other way around) has an effect the results of a study.
- chrisrxth 11y ago
  Could you elaborate?
  - matt504 11y ago
    Maybe they are taking the money that people pay him on this side and paying some other research subjects to do the same thing and is going to compare the results. It's weird to ask people to pay to be part of a study. So maybe that is actually part of what this person is studying. Maybe all the capsules are placebos and they are studying something else. Can you tell I like conspiracy theories? :) Oh I just noticed you are the person who posted this. You should do that, if this isn't what you're doing.
NietTim 11y ago
Hey! I've been taking L-Theanine for the past month. It feels to me like I've been waking up with a clearer mind, but it's super hard to know if that's form the l-theanine or just in general the change in the weather. So many variables.
- chrisrxth 11y ago
  Indeed it's difficult to tell - exactly the reason why a double-blinded trial on yourself can help you determine if it's making a significant difference or not :)
zxexz 11y ago
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 in the past). It would be interesting to hear if this happens to anyone else.
- jug5 11y ago
  If that's actually true (probably not), you have much bigger issues than L-Theanine.
- chrisrxth 11y ago
  Interesting. I've never heard of someone reacting to L-Theanine this way. Perhaps it could be an allergy?
- partisan 11y ago
  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.
  - zxexz 11y ago
    That's interesting. Now that I think of it, the nausea feels exactly like what you get from ingesting the tannins in overbrewed black tea. I just assumed my nausea from drinking green tea and from L-Theanine (which I know that green tea contains in a non-negligible quantity). Maybe levels of tannins in green tea are higher than in black tea? In that case the nausea from L-Theanine may be unrelated. Maybe it's a combination of both.
    - partisan 11y ago
      I think you might be on the right track, but I drink their green tea now and I don't get the same effect. I also drink overbrewed Twinings english breakfast tea with no negative effect.
filleokus 11y ago
I also love the idea, would really like to try it! Any chance to get it shipped outside the US (I live in Sweden)?
- Steer 11y ago
  You can order L-Theanine (L-Teanin) in Sweden without any issues. You will just have to figure out the double-blind part.
- chrisrxth 11y ago
  Not yet :( Like Steer said, you can still order Theanine independently of our company but I can let you know when we are ready for international orders if you send me your email!
rgejman 11y ago
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 Board (IRB) to sign off on your trial. Depending on the drug, you might also need an FDA waiver to conduct the trial. The PhD student (Rob Wagner) listed in the about section should have had at least one course on the responsible conduct of research. This course is required for most (all?) scientists working under a training or research grant from the NIH. Design and implementation of clinical trials--along with the ethical and legal issues involves--is standard fare for these courses for precisely this reason!
- rgejman 11y ago
  As an aside: it's a cool idea and worth trying--but you are going to need to make sure that you are compliant with this country's laws regarding the responsible conduct of human subjects research!
- chrisrxth 11y ago
  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 better, we are a supplement distributor that happens to help you record whether or not the supplements actually work.
  - ska 11y ago
    Cool idea, but as many have pointed out there are some potential issues with the execution. I'd suggest you get an additional formal legal opinion on applicability of HIPPA as well, it would be financial painful (up to something like $250k/record if I recall correctly) for you to get caught on the wrong side of that one. You should also (already) have a proper formal ERB.

57 points by chrisrxth 11y ago

Yikes! I'm a bit disappointed and slightly surprised that there's no discussion nor consideration of research ethics appearing anywhere on that website.

chrisrxth 11y ago
You bring up a good point! We will be adding some outlines about ethics soon. Thanks for reminding us of the importance!
- robbiep 11y ago
  I'm sorry, you have a website called doubleblind, you are asking people to pay to participate in the study, and you need to be reminded of the importance of thinking about ethics? There's a reason why science and medicine don't move the same way Web 2.0 does (ie move quickly and break things). It's because people have died from poor implementations, and people trialing drugs are prone to exploitation from unscrupulous merchants. Now I'm not saying there's anything wrong with your study, or your proposed aims. But if you want to be taken seriously and not shut down by whatever regulatory authority governs your territory, you need to think long and hard about this on both this study and any future studies/products you intend to sell. Do not screw this up, and do not make the mistake of approaching human health and clinical trials as though something critical like ethics review is something that can be 'patched' further down the line after the release date
  - chrisrxth 11y ago
    We chose L-Theanine because it has an excellent safety record, is well studied, and has no known toxic dose. We are very aware of safety and ethics. There are many nootropics and supplement companies safely distributing the same L-Theanine. While we work through our protocol we will continue to dive into ethics and safety.
    - robbiep 11y ago
      What you have stated here you have stated in your previous thread announcing doubleblind and presumably elsewhere. I don't have an issue with what you are choosing, or why. In fact, it doesn't really matter. What matters is that you have a clear and transparent ethics approval process, that you clearly state the steps your protocol had been through, and preferably that you submit your protocol to a human ethics review board, and identify that process openly and transparently. It sounds like you have already developed your protocol, since you are offering your product for sale shipping from the start of this month. So have you written an ethics proposal? Have you considered submitting it to a HERC? Or are you 'continuing to dive into ethics and safety' now that you have been 'reminded of the importance' of it? Don't get me wrong, I think your idea and platform is potentially great. But it really seems that you haven't thought about this, and now you're trying to scramble? If you don't have a science background and aren't partnering with anyone who is, I'd be more than happy to lend my 2c outside of this thread (see profile). Otherwise, I wish you every success with a full and detailed examination of your ethics approach. Medical research (which you are conducting by calling your product an experiment) has a poor history when it comes to blurring the lines between researcher and pharmaceutical company/monetisation, of which you could be said to be doing both at the moment.
    - ska 11y ago
      While we work through our protocol we will continue to dive into ethics and safety. This part, for what it's worth, is ass backwards.
    - xenophonf 11y ago
      [L-Theanine] has no known toxic dose. You keep saying this like it means something. Even _water_ has a toxic dose: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770067/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770067/ It really makes me wonder whether you have adequate human subject protections in place or if you just hand-waved those away by assuming L-Theanine was completely safe.
  - deleted 11y ago
    [deleted]
- OopsCriticality 11y ago
  Research ethics must be a central concern, not something hand-waved away with an outline at a later date. Maybe I'm getting a bad impression from your current website and comments, but appearances matter. The stereotypical "move fast and break things" attitude is wholly inappropriate here; human and animal research must be conducted with careful consideration and respect.

geoffwoo 11y ago

cool concept. interested in seeing the results.

nicw 11y ago

Looks promising. While it may seem obvious, I would spell out what double-blind means, the problem it solves, and how it is used elsewhere. That then sets you up to point out how doctors use these study types, adding credibility.

Lewton 11y ago

I absolutely love this idea. Are you gonna do a trial every month? Any schedule for which trials you're gonna run?

chrisrxth 11y ago
We're going to keep adding more trials - but there's no timeframe for when you have to start and end the trial. You can order it and start it whenever you receive it in the mail.

Robadob 11y ago

Interesting concept, shame it's limited to the US (understandable due to dubious legality of shipping unclassified chemicals between jurisdictions). Been interested by the apparent 'attention enhancing' qualities of L-Theanine, although not gone as far as purchasing any. By coincidence someone got me into drinking green tea a couple of weeks ago, I haven't noticed any visible change. Although I expect my problem is concentrating on the right thing, rather than simply failing to concentrate.

arsenico 11y ago
From my personal experience, L-Theanine, coupled with caffeine, produces very serious results in terms of negating bad coffee effects, increased focus and productivity, and better sleep
- Legogris 11y ago
  Same here. A couple of pots of strong sencha (Japanese green tea) give me a huge boost in energy and mood, without the negative effects of derealization, tunnel vision and restlessness I get from too much coffee.

deleted 11y ago

[deleted]

dbcooper 11y ago

How do you propose to analyse the data you collect?

doobiedowner 11y ago
I'm guessing that they're more interested in the collected cash. It's all about the chee$e!

detaro 11y ago

Show HN when the idea was presented: https://news.ycombinator.com/item?id=10401698 https://news.ycombinator.com/item?id=10401698

Steer 11y ago

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 stress that I love the idea, but the web site just feels incomplete.

vox_mollis 11y ago
What kind of responsibility does the company take for possible side effects? Probably the same kind of responsibility taken by green tea manufacturers.
- Steer 11y ago
  Fair enough. My impression was that this was the first of many similar experiments, but with different substances making my question perhaps more valid somewhere down the line.
  - chrisrxth 11y ago
    This is the idea - we'll have to address the safety and ethical concerns of each substance individually.
- DanBC 11y ago
  Green tea sellers don't make medical claims for their products; green tea sellers don't enroll people in "research".
  - chrisrxth 11y ago
    We make no medical claims about our product either - we only reference existing science.
    - 11y ago

matt504 11y ago

Maybe this actually part of a study to research whether having your research subjects pay you (rather than the other way around) has an effect the results of a study.

chrisrxth 11y ago
Could you elaborate?
- matt504 11y ago
  Maybe they are taking the money that people pay him on this side and paying some other research subjects to do the same thing and is going to compare the results. It's weird to ask people to pay to be part of a study. So maybe that is actually part of what this person is studying. Maybe all the capsules are placebos and they are studying something else. Can you tell I like conspiracy theories? :) Oh I just noticed you are the person who posted this. You should do that, if this isn't what you're doing.

NietTim 11y ago

Hey! I've been taking L-Theanine for the past month. It feels to me like I've been waking up with a clearer mind, but it's super hard to know if that's form the l-theanine or just in general the change in the weather. So many variables.

chrisrxth 11y ago
Indeed it's difficult to tell - exactly the reason why a double-blinded trial on yourself can help you determine if it's making a significant difference or not :)

zxexz 11y ago

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 in the past). It would be interesting to hear if this happens to anyone else.

jug5 11y ago
If that's actually true (probably not), you have much bigger issues than L-Theanine.
chrisrxth 11y ago
Interesting. I've never heard of someone reacting to L-Theanine this way. Perhaps it could be an allergy?
partisan 11y ago
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.
- zxexz 11y ago
  That's interesting. Now that I think of it, the nausea feels exactly like what you get from ingesting the tannins in overbrewed black tea. I just assumed my nausea from drinking green tea and from L-Theanine (which I know that green tea contains in a non-negligible quantity). Maybe levels of tannins in green tea are higher than in black tea? In that case the nausea from L-Theanine may be unrelated. Maybe it's a combination of both.
  - partisan 11y ago
    I think you might be on the right track, but I drink their green tea now and I don't get the same effect. I also drink overbrewed Twinings english breakfast tea with no negative effect.

filleokus 11y ago

I also love the idea, would really like to try it! Any chance to get it shipped outside the US (I live in Sweden)?

Steer 11y ago
You can order L-Theanine (L-Teanin) in Sweden without any issues. You will just have to figure out the double-blind part.
chrisrxth 11y ago
Not yet :( Like Steer said, you can still order Theanine independently of our company but I can let you know when we are ready for international orders if you send me your email!

rgejman 11y ago

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 Board (IRB) to sign off on your trial. Depending on the drug, you might also need an FDA waiver to conduct the trial. The PhD student (Rob Wagner) listed in the about section should have had at least one course on the responsible conduct of research. This course is required for most (all?) scientists working under a training or research grant from the NIH. Design and implementation of clinical trials--along with the ethical and legal issues involves--is standard fare for these courses for precisely this reason!

rgejman 11y ago
As an aside: it's a cool idea and worth trying--but you are going to need to make sure that you are compliant with this country's laws regarding the responsible conduct of human subjects research!
chrisrxth 11y ago
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 better, we are a supplement distributor that happens to help you record whether or not the supplements actually work.
- ska 11y ago
  Cool idea, but as many have pointed out there are some potential issues with the execution. I'd suggest you get an additional formal legal opinion on applicability of HIPPA as well, it would be financial painful (up to something like $250k/record if I recall correctly) for you to get caught on the wrong side of that one. You should also (already) have a proper formal ERB.