Hello everybody. If you're located within driving range of the Army's Natick Labs you may still be able to participate in the 21 day MRE consumption study. I believe that they are going to be collecting test subjects for several more weeks. You can contact the study team directly at firstname.lastname@example.org
I work about 45 minutes away from Natick. I love MREs (I was a P-3 Orion crewmember in the Navy and used to love eating them on the aircraft, which we could only do when deployed to USAF bases) and was initially quite excited about participating in the study. I contacted the Natick Labs using the e-mail address presented above. They sent me the study's terms and conditions and told me to contact them again if I was still interested so they could schedule a screening interview with me.
There's a lot of personal inconvenience associated with participating in this study, but the deal-breaker for me is that they actually need two separate groups of test subjects, one that will be eating nothing but MREs for three weeks (terrific) and another control group that will eat normal food (boring). The problem is that assignment to either group is random and they could not guarantee me that I'd be assigned to the MRE consumption group. Believe me, I tried to get a commitment from them, and they would not give it. Basically, you have to agree to participate in the study and then you take a chance that you will be assigned to the MRE consumption group.
I may reach out to the Natick Labs again in a few weeks and ask how they are doing collecting test subjects. Perhaps if they do not get the level of participation that they need they may be willing to bend the rules and guarantee me a slot in the MRE consumption group. I have a friend who is a member of a reserve unit in the local area who told me that his unit, and presumably others in the local area, were contacted by the Natick Labs a few weeks ago to provide volunteers. Nobody was willing to participate.
Here are the details and terms and conditions of the study that they sent me:
Thank you for your interest in our study.
Please note that to participate in the study you must be living in or be willing to visit the Natick, MA area for ~6wk. We cannot accept lab results from external laboratories. While compensation is provided for study participation, we cannot compensate for travel-related expenses.
Please continue reading for additional information regarding the study. If you are interested in participating after reading the study description below contact us at email@example.com
. We will respond within a few weeks to schedule an in-person or telephone interview.
MRE Study team
Title of Research: Effects of Meal, Ready-to-Eat (MRE) consumption on gut health.
New research shows us that the types and amounts of bacteria living in your gut influence your health. New research also shows us that the types of foods that you eat influence the types and amounts of bacteria in your gut. Therefore, the foods that you eat may interact with the bacteria living in your gut to influence your health. The purpose of this study is to determine the effect of eating nothing but the Meal, Ready-to-Eat (MRE) for 21 days on the types and amounts of bacteria living in your gut, on the health of your gut, and on you overall nutritional status. MREs are packaged military rations, typically eaten by military service members during combat and training. Each MRE provides one full meal that includes one of 24 different entrées, sides and dessert along with other assorted foods and beverage mixes.
You are being asked to be in this research study because you are a healthy adult between 18 and 62 years old. This study is being conducted with researchers from the US Army Research Institute of Environmental Medicine (USARIEM), and the Natick Soldier Research and Development Center (NSRDEC). The study will take place at USARIEM.
60 men and women are needed to complete the study. You can expect to be in the study for 6 weeks.
You do not have to take part in this study. Refusal to participate will not result in any punishment or loss of benefits to which you are otherwise permitted. Please read the information below, and ask any questions you may have, before deciding whether to be in the study.
You may take part in this research study if all of the following applies to you:
-You are 18-62 years old.
-Your body mass index (BMI) is ≤ 30 kg/m2.
-You are willing to eat nothing but MREs for 21 consecutive days.
You SHOULD NOT participate in this study if any of the following applies to you:
-You have taken antibiotics within the past 3 months; topical antibiotic use is ok.
-You are not willing to stop eating any probiotic, prebiotic or other dietary supplements you currently eat.
-You follow a vegetarian diet.
-You use laxatives, stool softeners, or anti-diarrheal medications at least once a week.
-You usually have fewer than 4 bowel movements per week.
-You have a history of gastrointestinal disease (such as celiac disease, irritable bowel syndrome, colitis, and Crohn’s disease).
-You have had a colonoscopy within the last 3 months.
-You have any food allergies or aversions or other issues with foods that would prevent you from eating MREs (such as gluten, milk, nuts, or eggs allergies or intolerances).
-You use aspirin or non-steroidal anti-inflammatory medications (NSAIDs; for example Aspirin, Aleve, Motrin, Advil, etc.) prescribed by a physician or clinician, or you are not willing to avoid using of these medications during the study.
-You are actively trying to lose weight.
-You are unable to meet with study staff 3 days/week.
-You are pregnant or lactating.
-You are not willing to avoid strenuous activity or alcohol consumption for 24 hr prior to testing days (there are 4 testing days during the study).
-If you have donated blood within the past 8 weeks you may have to wait before starting the study.
If you agree to participate in this study, you will be randomly assigned (like flipping a coin) to one of two different groups. No matter what group you are assigned to, your study participation will last approximately 6 weeks. During the first week (called the baseline week) you will be asked to record everything that you eat and drink over 3 consecutive days, and to provide fecal samples on 2 separate days. Then you will be assigned to one of two study groups and be asked to:
-Follow your usual diet or eat nothing but MREs.
-Record everything that you eat and drink on several separate days.
-Provide a blood sample 4 separate times.
-Collect all the urine you produce over 24 hours 4 separate times.
-Provide additional fecal samples 5 separate times.
During the study you will be required to meet with study staff at least 3 days each week on weekdays. Most of the study visits will take place in the Doriot building (NSSC building 2). However, other locations such as your home or place of employment may be used if more convenient for you. Research activities occurring at these locations could include exchange of study materials or samples, body weight measurement, discussing your diet, questionnaires, or exchanging MREs. Research activities occurring at these locations will not include blood sampling. If any visits occur at your place of employment, we will just ask that you obtain approval from your employer before we complete any research activities. Most of the visits will be short (less than 1 hour). Activities during these short visits will differ depending on the day of the study and the group to which you are assigned. These activities may include being weighed, completing questionnaires, reviewing food records, and/or picking up food. On 4 separate days during the study you will have a “test day” which will include a visit lasting about 3 hours. These visits will take place at USARIEM. While participating in this study you will not be permitted to participate in any other activities that involve greater physical or psychological stress than you are used to in your everyday life (e.g., certain research studies, strenuous exercise in the heat, long-distance hiking, etc).
You will be randomly assigned to one of two different study groups. Neither you nor the investigator will get to choose what group you are assigned to. In order to participate in this study you must be willing to be assigned to either study group.
The two different groups are the control group and the MRE group. If you are assigned to the control group you will eat your usual diet throughout the entire study. If you are assigned to the MRE group, you will eat nothing but MREs for 21 consecutive days and then eat your usual diet for 10 consecutive days. If you are in the MRE group, you will not be permitted to drink anything other than water and the beverages provided in the MRE during the 21-day MRE eating period. One exception is that you will be able to substitute your own black coffee for the coffee provided in the MRE. You will be provided with
2 or 3 MREs per day (including weekends). Whether you get 2 or 3 MREs per day will be determined by study staff and depend on how much you need to eat to maintain your body weight. All 24 menus will be offered on a rotating basis, and we will have a limited selection of MREs available for you to choose from every day. You may also be asked to consume a small amount of almond milk or a similar product on study days 9, 10, 20 and 21 if you are in the MRE group in order to increase the amount of calcium that you are eating.
There will be 4 “test days” completed during the study period (study days 0, 10, 21 and 31). You will be asked to fast (eat and drink nothing except for water) for
12 hours, avoid vigorous exercise and alcohol for 24 hr, and avoid smoking for 12 hr before meeting study staff in the morning. When you arrive, a trained technician will collect a blood sample by putting a needle into your arm. The total amount of blood collected during each sample will be 22 mL (~1.5 tablespoons). The total amount of blood collected during the study will be 88 mL (~6 tablespoons). We will measure various markers of gut health, inflammation and nutritional status in your blood. We will also save some of your blood. If we determine that eating MREs influences the health of your gut and the types of bacteria in your gut, we will use your blood to examine whether those changes are related to products of bacterial metabolism in your blood.
After the blood sample, you will be asked to drink water sweetened with sugar and 3 different artificial sweeteners then fast (no food or beverage other than water) for the next 5 hr. The sweeteners are sucralose, lactulose and mannitol. These sweeteners are used as low-calorie substitutes for sugar in a variety of common commercial food products. For the next 2 hours you will remain with study staff and collect all of the urine that you produce. You will then be allowed to leave, but will continue to collect all of the urine that you produce over the next 22 hours. Three hours after you leave (5 hr into the urine collection) you will meet with study staff to switch your used urine collection jug for an unused jug. You will urinate into that jug for the next 19 hr
(24 hr total urine collection), and then return the collected urine to study staff the next day. You will be given detailed instructions on how to collect your urine and the supplies needed to do it. You must be willing to carry the supplies with you wherever you go during the urine collection period (for example to work or to home). We will measure the amount of sugar and artificial sweeteners in your urine as an indicator of gut health.
You will be asked to collect your own feces on 7 separate occasions. Two collections will be during the week prior to starting the first test day, and the other collections will be approximately weekly during the 31 days thereafter. For each scheduled collection you will be given a 2-3 day window to produce and collect a single sample. If you do not provide a fecal sample during this window, the collection period will be extended until a sample is provided. If the sample you provide is too small for us to analyze (< 70 g), you will be asked to collect another sample, and the collection period will be extended until a sample large enough to be analyzed is provided. Likewise, if you produce a sample at a time when you cannot return it to study staff with 12 hr, you will be instructed not to collect the sample, and the collection period will be extended until you produce a sample and give it to study staff within 12 hr of collection. If you are in the MRE group, extending the collection period may require that the period during which you eat MREs be extended beyond 21 days. If you do not provide two fecal samples of sufficient size within 12 hr of sample collection during the final week of the study, your participation in the study will be extended until a sample of sufficient size is provided. You will be given detailed instructions on how to collect a fecal sample and the supplies needed to do it. We will use your feces to identify the types and activities of bacteria that are present in your gut. We will also save some of your feces to use in lab studies to determine how different nutrients influence the growth and activity of bacteria present in feces.
BODY HEIGHT AND WEIGHT
Your height will be measured at the beginning of the study, and your body weight will be measured 3 times per week during the study. You may be asked to wear only shorts and a T-shirt when being weighed. You will be required to maintain your body weight during the study. Staff may give you more to eat if you begin to lose weight, or less to eat if you begin to gain weight.
RECORDING FOOD INTAKE
Food records will be used to measure what you eat during the study. During the week prior to the first test day you will complete a questionnaire that asks about the foods that you usually eat. During the week prior to testing you will also be asked to write down everything that you eat and drink over 3 consecutive days. If you are in the control group, you will then record everything that you eat and drink over 24 hours on 9 separate days during the next
31 days. If you are in the MRE group you will then record everything you eat and save all of the trash from the MREs you eat over the next 21 days. You will be provided with daily food logs in order to make recording your daily MRE intake easier. After the 21-day MRE diet period you will eat your normal diet for 10 days and record everything that you eat and drink over 24 hours on 3 separate days. Study staff will instruct you on how to record your diet, and will review your food records with you.
You will be asked to complete two questionnaires weekly during the study. One questionnaire will ask about how your gut feels and the frequency of your bowel movements. The other questionnaire will ask about your physical activity habits. That questionnaire will also be used to make sure that you maintain your usual everyday physical activity habits throughout the study.