I assume participants are drinking water?

Water is the drink during the study, plus 8 oz of orange juice. No coffee or alcohol.

Hi Laura,
This sounds like a great study! I hope the next step will be vegetarians because clearly the gut microbiota could be different (just based on smells, etc). Or meat eaters switching to a week of veggie only. Or how do spices affect our microbiome? So many questions! To me, the big one is how does the rest of a person's environment interact with the diet and microbiome. (There was an interesting study in which a grad student looked at his gut microbiome for an entire year while cataloging what he ate and did. What was interesting is how traveling caused changes that were all temporary when he returned home.)

I was about to send this to a list of people who would almost certainly be interested in participating, and have a few questions. I realize you have posted contact information, but these are of the FAQ variety that will save others from having to email individually, and one serious question that everyone should know the answer to up front. (And you might see why I would prefer to ask the question anonymously here. Read on.)

1) Are there any age limits on participants?
2) When is the deadline for signing up?

3) Lastly, when I was considering participating in a breast cancer study - a worthy endeavor looking at genes and early blood markers of breast cancer and trying to correlate with later results - the disclosure seemed very straightforward until I got into some fine print later on that said that I was ceding the right for my DNA to be sold to commercial interests in perpetuity without notice and that they couldn't protect my personal information as anonymous then either. Wow.

Some people might still be okay with a study giving away such broad rights, but many aren't - and the disclosure should have been up front with the other disclosures, and potential consequences outlined for ethical patient informed consent. I honestly don't know how that study consent form passed the institutional review board at Stanford. But it was Stanford, which is why I am asking now. That point was so buried in the fine print, it made not trust the study organizers (made me feel like selling participants' DNA and health histories was the point of the study) and I regretfully had to decline to participate.

Since you mentioned that this diet study is going to be concerned with genes and will be taking blood, I would like to know if this study has better protections of participants' genetic information than in the study I mentioned above, or whether it, too, contains a poorly disclosed wholesale ability to sell people's genetic information in perpetuity to commercial interests?

Oops, just saw the 18 years and older, don't know why I missed that.

So I just have the two questions:
Deadline on enrolling
Does enrolling mean wholesale giving away the right for them to sell my DNA and health information to other interests later/unrelated to this study?

looks healthy but kind of boring to eat 3X a day.

Ahh, the inevitable negative comment - I was waiting for you! A comment that deserves a detailed answer. That IS one of the main concerns In & Out Man, when building this bowl. It had to be a bowl because of the need to eat the same foods at the same time. The ingredients, except the seasoning, were predetermined from The National Health and Nutrition Examination Survey (NHANES). As bowl designer I had to seriously think - what seasoning is best for someone to eat the whole week? I started thinking tomato-based, but then realized yuck to tomato essence for breakfast,and actually any standout flavor because of the repetition of the meal. After much thought and testing - I landed on a savory gravy, which I think answers all the needs. What might you have suggested instead? I'm open to ideas.

Prospective Participant - I am getting your answers

I'm so interested in this, right up to the...

No coffee.

Hah!

To answer Prospective Participant, you have valid points!
We are hoping to finish enrollment by the end of November.
As for your data, we will measure metabolites in urine and blood, and see who is growing in the stool samples. We will look at the microbial genes, but not yours. We are not ever selling any of the data.

>What might you have suggested instead? I'm open to ideas.

Possibly some menu variety but with the same detailed attention to nutritional/ health concerns & necessities.

I have gone the macrobiotic route in the past. It was OK for a week or two & I did notice some personal improvements...clearer head, less sluggishness and perhaps most importantly, regular-firm bowel movements.

Natural fiber though often low in nutritional value has a way of cleaning out the lower intestines like a broom & that is important in addition to adding stool bulk.

BTW, I still have an occasional dinner consisting of tofu, brown rice and steamed vegetables (or a salad).

On the other hand, i wouldn't want to eat this every day or go full vegan...life is too short not to enjoy stuff like burgers, ribs & pizza.

Lastly, my 'In & Out' refers not to the burger chain but rather what food goes in...usually comes out.

@Study Coordinator,
Thanks! I feel comfortable sharing the study now. Good luck with it!

@Laura,
I can't imagine anyone would have trouble trying something just for a week, especially something you put so much thought into.

It looks like the hippie food we used to eat back in the day.

"...see who is growing in the stool samples."

When I was a kid, I had to submit one of these.

Being a natural-born practical joker, I scooped up a piece of my dog's poop & submitted it just to see what would happen.

The lab results were off the charts.

QUOTE: The lab results were off the charts.

I would imagine so. *L*

Hmm.
You included meat in the bowl because "the average American eats meat".
But you exclude coffee (and alcohol) despite the fact that the average American adult drinks coffee (and probably alcohol...we do live in California).

I would do this, but for the meat problem.

You had me until the no coffee.

But was concerned about cholesterol content,

Please respond.

>>But was concerned about cholesterol content,

And sodium content of 'gravy'.

Also, is the meat pictured chicken and ham? If pork is being included, Orthodox Jews and devout Muslims will not be able to participate in this food study.

To answer VeriVeggie: the reason to exclude alcohol and coffee is that we are looking at a myriad of metabolites in the urine which would be masked by these drinks.

To answer Bet: the old Dietary Guidelines included a recommendation to limit dietary cholesterol to no more than 300 mg per day. The new Guidelines removed that recommendation as evidence has shown that dietary cholesterol does not have such a large impact on blood cholesterol levels as we thought. Still, the cholesterol levels of the test meal do not exceed 300 mg per day.

To answer the Rabbi: there is no pork in the meal, but there is meat and cheese, which would still exclude Orthodox Jews. We are planning on doing another cycle with a vegan meal and Muslims and Orthodox Jews will be able to join.

microbe-biotic ... oh, groan! ;-)

Anyone serious about this and interested in it would be happy to eat the same thing for a measly week. The sticking point for me anyway, I would think would more likely be the blood, urine and stool samples.

The food looks really good anyway, I like healthy food and probably already eat much like what is posted. Healthy food and understanding what is healthy food is always good. it does appear from the picture that you have shorted the "greens" part of the diet?

Good luck on your study.

What do you do if someone gets seriously addicted to your bowls? Do you sell them?

> We are not ever selling any of the data.

Famous last words. My God, what we have to be cognizant about these days, now we have to mind where our DNA ends up? Sheesh!

>>>the reason to exclude alcohol and coffee is that we are looking at a myriad of metabolites in the urine which would be masked by these drinks.

So smoking a little pot before dinner is OK?

You know...to stimulate one's appetite.

@CrescentPark,
“Famous last words. My God, what we have to be cognizant about these days, now we have to mind where our DNA ends up? Sheesh!"

There are specific ethical legal guidelines that all studies have to follow including disclosure to patients before they consent. If a study properly discloses that patients are signing away the right for a third party to sell their DNA and medical information in perpetuity and that once the data is sold, their name and private medical indormation will no longer be protected, and there is some discussion if the potential impact to the patient, that is one thing. But to bury that disclosure in mouse print long after the other patient disclosures is another. I was really upset because they get you to start signing with an ipad long before you even see that disclosure. The whole thing seemed so unethical. That, by the way, has nothing to do with this study which soinds above boatd.

>>>What do you do if someone gets seriously addicted to your bowls?

(1) Assume that they've never eaten a really good meal before OR (2) that they are suffering from some sort of obsessive-compulsive disorder.

> ....kind of boring to eat 3X a day.

Listen...if you were starving to death (or from some 3rd world country), you'd be eternally grateful for a macrobiotic bowl.

Fortunately you probably don't have to resort to such extreme measures.

The purpose of the bowl is not to entertain your dinner guests or to be exciting, it's to test a scientific theory. No matter - my attempt was still to make science tasty, and I think we have achieved that goal.

(1) Rather than using zip-lock bags (as per the pics), consider 'seal-a-meal packaging' to ensure food safety measures.

(2) Calories per meal & nutritional %s should be listed.

(3) MD's approval prior to participation in this study should be mandatory.

(4) Cooking instructions must be explicit to ensure proper consumption temperature.

(5) Refrigeration instructions/warnings must be explicit (if required).

(6) A full listing of actual ingredients(including gravy) should be included.

(7) Waivers covering mishaps due to examinations/lab tests.

Just saying in order to avoid any possible litigation...my specialty.

Thanks Attorney - we're planning for much of what you list and appreciate the list and professional advice.

An addendum:
(8) A warning pertaining to any potential food-related allergens.

Thanks Attonrey, I am still hoping one of our readers adds more about the role of genes in our bodies.

Another area worth exploring...

> Macrobiotics/Gene Therapy/Cancer Recovery

Web Link

Sattilaro, A. J. & Monte, T. (1982) Recalled by Life: The Story of My Recovery from Cancer Houghton Mifflin Boston, MA.

And clarification to everyone, this study has nothing to do with macrobiotics. We have Food Partied! about macrobiotics in the past, as I trained at Vega Macrobiotic Center in my younger years, but I called the bowl a Microbiotic Bowl just as a play on words.

"> Macrobiotics/Gene Therapy/Cancer Recovery"

If your Macrobiotic Bowl can cure cancer or alter the gene structure of the disease, you & your colleagues are the next global pharmaceutical billionaires as well as Nobel Prize winners in Science & Medicine.

Good luck. Others will be taking note of the lab results.

Just an afterthought. You wouldn't have to go 'big pharma'. Just sell the recipe to the highest bidders in the food manufacturing industries.

Or if less avaricious, create a DIY cook book.

Hurumph...yah, good luck...pshh.

A freeze-dried version would be a worthwhile offering...for campers and survivalists alike.

When/if the apocalypse (or second coming) finally arrives, a reliable inventory of military MREs or dehydrated Macro Bowls could mean the difference between preserving your family's legacy or the total extinction of its family tree.

Food will be scarce and stores will be closed. Better to let the others perish.