I am most concerned that the formulation (amounts and forms) is settled before Saturday, and it seems there is no longer any MAJOR disagreement on this aspect of the endeavor. If there is, experts should make their final arguments now.
No major arguments. Looking at the formula, I'd like to see citrates instead of glycinates, Cr picolinate instead of polynicotinate, and would really prefer to see a full dose of choline -- and then there's what has turned into the most active ongoing discussion:
As far as the dry/beadlet/oil/softgel/hard cap, discussion goes we can continue that while the product is being priced. Once we have a general idea of the price, then we can decide if we want to add some additional cost by putting the fat soluble vitamins in a lipid carrier.
I think it's sensible to have a quote from prospective manufacturers. In evaluating how much we're willing to bump up the cost and complexity of the delivery system, I think it's important to weigh
intention-to-treat reasoning: as I said early on in my relationship to the Holy April, "The best calcium supplement is the one you actually take." I suggest that a significant uptick in the price may well drive people to buy a cheaper, inferior product elsewhere (including but not limited to both "dangerously" inferior ones and ones that may actually look a lot like our formula, but in the cheaper delivery of a gelcap-only formula), and to what extent having to take and keep track of 2 sets of pills (ie, "take 5 of these and 2 of these a day") will drive even people who buy it to not follow thru' with taking the whole regimen on a regular basis, leading to what is clearly an inferior outcome.
Now, since lycopene is the key nutrient driving the impulse to split the thing up, I'm happy to report that I actually have some
data to insert into the discussion: (1) compared the bioavailability of 4 formulations in 24 subjects. "All persons were advised to minimize their carotenoid intake from food for a 2-wk initial [washout] period and the following 4-wk of supplementation by avoiding food rich in lycopene such as tomatoes and tomato products, watermelons, yellow and red pepper, pink grapefruit, papayas, apricots. After the depletion period, they ingested 5 mg lycopene daily after breakfast for 4-wk". I give the absolute (subject mean ± s.d) and percentage change (in brackets) in plasma lycopene levels at the end of the study for each; change values with a given superscript letters are not significantly (p < 0.05) different from others with the same superscript letter:
Capsule nr 1 Soft gel capsules containing tomato oleoresin [Lyc-O-Mato], ground to lycopene crystals size below 10 µm: 0.35±0.15 (0.28±0.14
a)
Capsule nr 2 Soft gel capsules containing tomato oleoresin, ground to lycopene crystals size below 10 µm, plus surface active agents: 0.32±0.08 (0.19±0.13
b,c )
Capsule nr 3 Soft gel capsules containing tomato oleoresin from which certain fraction of lipids was removed. Lycopene crystals in this sample were not physically treated (10 - 30 µm): 0.38±0.12 (0.23±0.11
a,c)
Capsule nr 4 Hard shell capsules containing tablets grade of synthetic lycopene (< 2 µm): 0.29±0.10 (0.14±0.09
b,d)
Capsule nr 5 Hard shell capsules containing spray-dried 1 - 2 µm size lycopene crystals crystallized from tomato oleoresin on modified starch as a carrier: 0.25±0.18 ( 0.08±0.14
d)
So, if we go with an unified, dry-powder-hard-capsule formula with either crystalized oleoresin (probably the most expensive
raw material , tho' final cost would be cheaper than either separate-softgel option) or (somewhat surprisingly) synthetic lycopene (certainly the cheapest), we'd be losing somewhere between 1/4 and half of the bioavailability of one of the gelcap options, if taken with a meal (tho' this possibly exaggerates the difference, as breakfasts were whatever subjects ate at home, and this could be cereal and nonfat milk, eg).
I suggest we just double the lycopene dose, which would certainly not be an overdose (we have 10 mg on the spreadsheet, and I'd originally put 18 mg in OrthoCore as being the highest high-end intake in the prospective epidemiology I could find) and (while we can get a quote) I am sure will be cheaper than a split formula, even with crystalized Lyc-O-Mato (and it appears we'd be absolutely fine, and probably better, with the cheaper synthetic).
-Michael
1. V. Böhm.
Intestinal Absorption of Lycopene from Different Types of Oleoresin Capsules. Journal of Food Science. 2002 Jun; 67(5): 1910 - 1913.
Edited by Michael, 22 January 2010 - 04:32 PM.