[Rhonda]: So for people that aren't familiar, the myCircadianClock app can be found on the
website myCircadianClock.
And it's basically you're crowdsourcing data.
You know, people that want to try this time-restricted eating out can try it out and also send their
data to you and take pictures of their food so that you can gather data for your study,
yeah.
So that's kind of a neat thing, that people can participate.
While they're trying this out, why not contribute to science?
[Satchin]: Yeah.
I mean what we realized is even if we get the best funded clinical trial grant from
NIH or DoD or any funding source, most of the clinical studies are done with people
who live within 20 to 30 miles radius of a clinical center.
And so in that way, even if we foresee there will be five or six clinical trials in this
country, there will be only five or six of those centers.
And people who are living within that 20 to 30 miles and have time and energy to travel
to a clinical center, spend almost half a day and every two to three months or two to
three weeks will participate in this study and will see the benefit firsthand.
Then we realized that in that way most clinical trials which are low risk like this one actually
will benefit...or will sample a very small fraction of people.
So that's why I came up with this idea that if we have a study that's approved by our
ethics committee and we make sure that we maintain the privacy of people, we don't sell
this data, we don't share this data with anybody else, and we give that assurance up front,
then we may be able to recruit or enlist participants who are not living within 40 miles who don't
have time to come to a clinical center, but are willing to share their data for science.
And they can live anywhere in the world, they can share their data.
And in this way this has been extremely useful because, again, in any clinical trial if you
look at the exclusion criteria, there is such a long exclusion criteria that only 1 in 50
or 1 in 100 who even shows interest in participating, they can participate.
But if we take that result and then try to disseminate to the rest of the people, those
49 or 99 people who could not qualify, then how are we expecting that this would be applicable
to all of them?
So it's kind of a conundrum.
So that's why we thought let's try this way where the only exclusion criteria is if you
are below 21 because that's NIH's mandatory exclusion criteria.
And in this way not only we can see whom it will benefit, we may also see whom it will
not benefit.
So we can actually a priori figure out what are the limitations of TRE.
And people who don't qualify, for example shift workers, they're mostly excluded from
many clinical studies because of the nature of their work, they cannot come to the clinic
at the right time, and this is more relevant to them.
So now we have thousands of people who are shift workers and they're trying this.
And from them we are also learning what they can adapt and how they can adapt this TRE
into their lifestyle and whether it helps them with alertness being on the job and whether
it helps them to sleep on the weekend and all that stuff.
So that way this has been extremely useful to have this kind of study and sometimes we
even get responses from our users that we had never thought about.
So we take that response and see, "Hey, can we do this animal study and see what is going
on?
What is the biochemical basis for this?
What is the physiological response in animals?"
Maybe that's how we can address...
For example, there are many cases there are many immune-related diseases and people report
that this immune-related disease has improved on the time-restricted eating.
And that is surprising for us.
But then we went back to our animal data and we realized that, yes, we actually see systemic
inflammation goes down with time-restricted eating.
And that makes sense.
If the systemic inflammation goes down, then many immune-related or inflammation-related
diseases would also go down with time-restricted eating.
So there are some examples like this where our human participants tell us their story.
And if it is one or two person, we may not take it seriously.
But then it's 4 or 5 or 10 or 15 people telling us the same kind of story.
For example, many IBS patients who have irritable bowel syndrome who have been going to the
toilet for five, six, seven, eight times every day.
They do TRE, and then they immediately see that the number of times they go to the bathroom
has gone down.
It's a huge improvement for them.
And then we might hear this story once or twice, we may not take it seriously.
But then if we hear it 5, 6, 7 times, then we start thinking, "Okay, let's go back to
our animal data."
Because from all these animals we have collected every tissue that's imaginable and we have
a freezer full of tissues.
And then we go back and test what might have changed, what might be changing in the gut,
what might be changing in the intestine, did the microbiome change, did the interaction
between the microbiome and the horse change.
And that helps us to come up with newer hypotheses and do more focused studies.
So this has been extremely useful for people to go sign up on the myCircadianClock website,
and then download the app and share their data and also share their experience.