FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 15, 2016 20:28:31 GMT -5
I was wondering why is it so important to not exercise 72 hours before screening? They always say it on the screening appt. and they always say no orange juice or caffeine( alcohol)and xanthanol? Some type of sweetener or star fruit for 48 hours prior to screening. i have never asked them why . I am very good about the fasting and I fast 12 hours just to make I exercise a lot so it really just about kills me to not exercise so I usually stop two days prior.
Does anyone know the logical reasoning behind this.
|
|
|
Post by puntkicker on Sept 16, 2016 5:07:10 GMT -5
Someone can probably explain it better than me, but I believe it is more to do with starting a new routine or increasing the current one. It alters your physiology, although I dont know the specifics. The grapefruit inhibits an enzyme, which some folks actually use to their advantage for some substances, but it's not a good thing in these studies.
I'm curious to see more details on the exercise, as I've been wanting to get back into the habit myself.
|
|
|
Post by subject on Sept 17, 2016 18:54:49 GMT -5
puntkicker is right. Exercising can alter your physiology. Clinical studies show that it can affect liver function as well as WBC (White blood cell). Five out of eight studied clinical chemistry parameters (AST, ALT, LD, CK and myoglobin) increased significantly after exercise (P < 0.01) and remained increased for at least 7 days postexercise. Bilirubin, γGT and ALP remained within the normal range. The liver function parameters, AST and ALT, were significantly increased for at least 7 days after the exercise. In addition, LD and, in particular, CK and myoglobin showed highly elevated levels. These findings highlight the importance of imposing restrictions on weightlifting prior to and during clinical studies. Intensive muscular exercise, e.g. weightlifting, should also be considered as a cause of asymptomatic elevations of liver function tests in daily clinical practice. www.ncbi.nlm.nih.gov/pmc/articles/PMC2291230/www.scielo.br/pdf/spmj/v121n1/16127.pdfStay with your study restrictions if you want to stay in the study. Many people get away with exercising or eating certain foods but you're literally rolling the dice. People's body can get used to exercising and thus not have elevated parameters but ultimaely you are still taking a risk, especially with weightlifting. Not only are you going to increase your creatine and liver functions, by building muscle you are creating tiny tears in your muscle. Your body then repairs them which could alter your levels because your body is technically wounded or going through repair. Caffeine can elevate your blood pressure and heart rate and grapefruit / some types of sour oranges can contain compounds known as furanocoumarins that block the CYP3A4 enzymes. When grapefruit juice is consumed, the enzyme's ability to break down many drugs for elimination is decreased. Blood levels of the drug may rise, resulting in the risk for new or worsened side effect when taking a drug. Since the investigational drug(s) are usually first in human trials, you are gambling with your own health by not following these restrictions as even the doctors do not know the full extent of what these drugs do to the human body. These side effects can greatly increase since certain fruits block the enzyme to breakdown many drugs, the amount of drug in the drug can be equal to taking 10x or even 100x+ the amount of the investigational drug and you may end up having life threatening adverse effects. These narrow parameters allow lab technicians and physicians the greatest diagnostic margin (blood work) by introducing no dietary variables into the procedure.
|
|
mike
Moderator
Posts: 334
|
Post by mike on Sept 17, 2016 21:05:49 GMT -5
It's the strength exercises that elevate liver enzymes, cardio does not significantly affect your labs.
|
|
FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 18, 2016 16:23:36 GMT -5
It's the strength exercises that elevate liver enzymes, cardio does not significantly affect your labs. Ok thanks as I have had my creatine levels off and wondering if that was enough to get me released from the study before dosing. i do fast at least 12 hours whether they say fasting or not just be be safe. Sometimes they have said that I don't need to fast but I would rather be safe than sorry. Never really thought about the orange, grapefruit and star fruit thing since I don't eat or drink them anyway but it is good to know that they might inhibit my eliminating the study drug from my system. On another note, does anyone take a detox when you get out? Thought about it but am looking for a cost affordable one, someone in a study mentioned charcoal in pill form.
|
|
FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 18, 2016 16:42:06 GMT -5
puntkicker is right. Exercising can alter your physiology. Clinical studies show that it can affect liver function as well as WBC (White blood cell). Five out of eight studied clinical chemistry parameters (AST, ALT, LD, CK and myoglobin) increased significantly after exercise (P < 0.01) and remained increased for at least 7 days postexercise. Bilirubin, γGT and ALP remained within the normal range. The liver function parameters, AST and ALT, were significantly increased for at least 7 days after the exercise. In addition, LD and, in particular, CK and myoglobin showed highly elevated levels. These findings highlight the importance of imposing restrictions on weightlifting prior to and during clinical studies. Intensive muscular exercise, e.g. weightlifting, should also be considered as a cause of asymptomatic elevations of liver function tests in daily clinical practice. www.ncbi.nlm.nih.gov/pmc/articles/PMC2291230/www.scielo.br/pdf/spmj/v121n1/16127.pdfStay with your study restrictions if you want to stay in the study. Many people get away with exercising or eating certain foods but you're literally rolling the dice. People's body can get used to exercising and thus not have elevated parameters but ultimaely you are still taking a risk, especially with weightlifting. Not only are you going to increase your creatine and liver functions, by building muscle you are creating tiny tears in your muscle. Your body then repairs them which could alter your levels because your body is technically wounded or going through repair. Caffeine can elevate your blood pressure and heart rate and grapefruit / some types of sour oranges can contain compounds known as furanocoumarins that block the CYP3A4 enzymes. When grapefruit juice is consumed, the enzyme's ability to break down many drugs for elimination is decreased. Blood levels of the drug may rise, resulting in the risk for new or worsened side effect when taking a drug. Since the investigational drug(s) are usually first in human trials, you are gambling with your own health by not following these restrictions as even the doctors do not know the full extent of what these drugs do to the human body. These side effects can greatly increase since certain fruits block the enzyme to breakdown many drugs, the amount of drug in the drug can be equal to taking 10x or even 100x+ the amount of the investigational drug and you may end up having life threatening adverse effects. These narrow parameters allow lab technicians and physicians the greatest diagnostic margin (blood work) by introducing no dietary variables into the procedure.
|
|
FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 18, 2016 16:44:10 GMT -5
Thanks for the great information. I love to exercise but have learned that I have to stop two days prior to screening and two days prior to check in. I have learned the hard way so I appreciate the science behind it.
|
|
mike
Moderator
Posts: 334
|
Post by mike on Sept 18, 2016 17:46:13 GMT -5
For at least a couple years every study I have done I will do a run on the day before I check in. I like the idea of getting in some activity before I'm stuck inside for a while. Quite often my exercise will be in the evening and less than 12 hours from the time I check in and give blood for labs, I have never had a problem with them. My runs are typically 2 to 3 miles, plus about 1.5 mile fast walking, plus maybe another half mile of speed intervals - short runs of over 10 mph. Then I do some stretching. I can't speak to other cardio like elliptical or stationary bike, but I would think that they would be safe. I would be leery of rowing or stairclimbing because they emulate strength exercises but I don't know.
I have not done much strength training for a long time, but in recent months I have started again, I have read in numerous places that you need at least 48 hours for liver enzymes to return to normal after strength exercises and possibly as much as 7 days.
|
|
|
Post by puntkicker on Sept 18, 2016 22:39:00 GMT -5
For at least a couple years every study I have done I will do a run on the day before I check in. I like the idea of getting in some activity before I'm stuck inside for a while. Quite often my exercise will be in the evening and less than 12 hours from the time I check in and give blood for labs, I have never had a problem with them. My runs are typically 2 to 3 miles, plus about 1.5 mile fast walking, plus maybe another half mile of speed intervals - short runs of over 10 mph. Then I do some stretching. I can't speak to other cardio like elliptical or stationary bike, but I would think that they would be safe. I would be leery of rowing or stairclimbing because they emulate strength exercises but I don't know. I have not done much strength training for a long time, but in recent months I have started again, I have read in numerous places that you need at least 48 hours for liver enzymes to return to normal after strength exercises and possibly as much as 7 days. Thanks, I appreciate this information. I have struggled sticking to a routine much of the time, and knowing exercise can throw my results off has given me a very good excuse(in my mind, at least), not to start again now as I await to hear if I'm in in a study. The 2 day thing doesnt bother me much, but 7(or who knows if even more is possible) makes me a bit nervous. I'm not much into cardio, unfortunately. Ironically, while I was reading this thread yesterday, I had a video playing in the background about why antioxidants are bad for you. Some guy called the Urban Monk(tm) had a guest on who was talking about "Hormesis", or basically "what doesn't kill you, makes you stronger". And with exercise, he mentioned that you arent helping that concept if you do the same routine, instead of changing it, basically the opposite of what we're told to do before studies. You can see why I found it ironic listening to that and coming upon this thread, right? They were talking about how things like climate control, along with taking antioxidants, has made us less healthy. I dont know if I endorse the message, but I certainly don't have reason to disagree with it at this point. Apparently change in routine isnt just beneficial for getting you closer to inner enlightenment, but also lends to better physical health. My description doesnt give the discussion justice. If anyone is interested in throwing it on in the background, you may find it interesting. You may also see the irony I saw, when what they were promoting was the opposite of our goals during sample collection, at least. (although I suppose having to give up the antioxidant portion of my supplements for studies may be good according to them) theurbanmonk.com/antioxidants-are-bad-for-you/
|
|
|
Post by puntkicker on Sept 18, 2016 23:03:24 GMT -5
I'd also like to add that exercise can increase red blood cell count, which may be one of the things we're judged on when compared with each other, for all I know. I'm trying to get as scientific about my understanding(if not practice) to increase my chances. Of course, we're sharing this useful information with the hordes of lurkers(about a 30:1 ratio of guests to users, when I looked recently) who could be seen as competition.
|
|
mike
Moderator
Posts: 334
|
Post by mike on Sept 18, 2016 23:06:30 GMT -5
A lot of the study restrictions that clinics tell you are erring on the side of being very cautious, and a lot of what you read is very general. I am pretty sure that unless you do some crazy 6 hour weight lifting orgy, your liver will be back to normal in probably 48 hours, maybe less. You could test it, by either paying for some tests yourself, or maybe screen for a study that you don't really care about getting into and let the clinic tell you if your liver is normal 2 days after a workout.
As for antioxidants, I don't think they make us "weaker", it's pretty clear that they neutralize stuff that is harmful to us. That said, I think you should try to get all the antioxidants you need from food, not supplements. Most supplements don't seem to be helpful and are often harmful, particularly in high doses.
|
|
|
Post by veteran2 on Oct 12, 2016 0:50:39 GMT -5
I used to work a manual labor job and couldn't do a physical on any day but Monday unless I took time off from work. I also used to lift weights and the 48 hour no physical activity restriction was fine for me. I can't remember if they had caffeine restrictions back when I did studies regularly but I also barely drank any coffee then.
|
|
|
Post by FloridaGirl on Oct 16, 2016 16:16:25 GMT -5
I have started to do NO weight liftin g 2 days before screening and check in I do cycle and some running maybe 2 days before check in but the day before i rest and drink a lot of water, usually spring water. I also stop caffeine and alcohol three days prior to check in. I do take some mineral vitamins like vit d pottasium and magnesium and i ue to take them since i take them everyday and dont want my levels to be off. I also fast 12 hrs before check in and for screening. I guess it is finding what works for u My only issue was my creatine being a little high And my glucose was running at 99-100 So i stop exercising, espically weight training and fast at least 12 hrs and i have no problem.
So as it has been said before everyone is different so learn what works for your body.
And i do what they say about no motrin or aspirin or cold medicine And of course the no grapefruit or oranges My job is to pass screening and the labs at check in so i am learning what works and what does not.
|
|