Nutritips, Training and What Nots

This entry was written by Jean Jitomir MS, RD and Darryn Willoughby, PhD.  Dr. Willoughby is the scientist who ran the Novedex trials at Baylor University (the same studies cited in Gaspari ads now).  Jean is a PhD student at Baylor, specializing in Exercise Nutrition.

Bodybuilders and sportsmen are always looking for a competitive "edge" and new ways to pack on muscle.  Steroids and other anabolic compounds are effective.  However, the available compounds are often impure, unpredictable, and illegal.  To fill the void, a slew of supplement companies cropped up, and they all claim to have the most novel and potent mass-building formulations.  Unfortunately, very few companies have the funding or consideration to test their products in a scientific trial.

As consumers become more informed and the competition in the supplement industry increase, supplement companies are compelled to back their products with scientific evidence.  There are some researchers who stand out this area of research.

Dr. Willoughby built his reputation in the scientific community with muscle signaling research, and his work significantly influences the recommendations for practical aspects of training and supplement formulations.  In recent years, he has also conducted a significant amount of supplement testing.

Novedex XT is a Gaspari product designed to increase endogenous testosterone levels, build muscle, and lean out the physique—it was also a supplement under investigation in Dr. Willoughby’s lab.  He chose to test this supplement because, though a number of supplement products being sold were claiming to increase circulating testosterone, no research had been published to support or refute these claims.

The Background

1.         Novedex XT is a supplement that has an aromatase inhibitor (AI).  Aromatase is the enzyme that converts androstenedione to E1 and testosterone to E2.  Therefore, and AI is designed to work by two different mechanisms

• Retention of circulating testosterone, since it is not converted to E2
• Increased endogenous production of testosterone, since the E2 feedback to the pituitary is also blunted

2.         The study was placebo-controlled, double-blind, and used the dosage recommended on the back of the bottle.

3.         The 16 men who were included in the study were 1) already weight-training for at least 3 years; 2) an average of 26 years; and 3) cleared with a medical screening before enrolled in the study.

4.         The study looked at the effects of Novedex XT on body composition, circulating hormones, and clinical safety and biochemical markers 1) before starting the supplement; 2) after 4 weeks of supplementation; 3) after 8 weeks of Novedex XT; and 4) after 3 weeks of stopping supplement use.   It did not assess strength directly.     

The Results 

1. At the dosage recommended on the packaging, Novedex XT significantly raised total and free testosterone and DHT levels in normal, weight-trained young men after 8 weeks of supplementation.

Including a 283% increase in total testosterone, 625% increase in free testosterone, 566% increase in DHT, and a 483% increase in the testosterone: estrogen ratio

2.  Body fat was significantly reduced, though total body weight stayed the same

• 3.5% of body fat (by weight) was lost

3. Along with the significant increase in serum androgens, estrogen is only slighted elevated, which indicated that the supplement blunted aromatase activity.

• The enzyme that converts testosterone to estrogen was inhibited, which allowed for an increase in circulating testosterone, without taking any external androgens

4. No abnormal changes occurred in whole blood and serum clinical chemistry markers

• After 8 weeks of supplementation, the men did not have changes in circulating safety markers, like LDL (bad) cholesterol), immune cells, or liver enzymes.

5. Novedex XT effectively increases circulating androgen levels and, when combined with a heavy resistance training program, may lead to increases in muscle strength and mass.

• Based on previous research, AI are highly effective for correcting the low testosterone levels of men who are low, e.g., aging men

FAQ: Side Effect Concerns Noted on Forums

Though no negative side effects were reported by the 16 men in the clinical trial, there are some concerns that I noted while searching through the Novedex forums, which I want to address here.  

It must be understood, however, that forums are purely testimonial and the writers are ALMOST NEVER just taking one supplement.  The young men in the clinical trial were excluded if they took any supplements, other than a multivitamin for several months before the study. 

Many men use an AI after a cycle of steroids to ramp up endogenous production of testosterone.  Clearly, if the men were taking hormones right before taking the supplement, their symptoms could easily be attributed to the steroids or the reaction the body has to stopping a cycle of outside hormones.

I consulted with Dr. Willoughby to address some of the potential side effects that are discussed on the Novedex boards.  His responses are bold and italics below.

1.  Hair loss and acne.   Novedex XT significantly increases DHT, a hormone that is associated male pattern baldness (MPB) and acne.  If you do not have a genetic predisposition to MPB, the supplement is unlikely cause a negative side effect in this regard; however, if MPB is typical on your mother’s side of the family, the increase in DHT may be a concern for you.

This is likely since we observed DHT levels to increase dramatically. Therefore, as with Anabolic Steroids (AS), guys who are prone to male pattern baldness should be aware. Also, older guys with increased prostate cancer risk (or with family histories) should also be aware [that increased levels of circulating DHT may leave you more susceptible to DHT side effects]

Anecdotally, I noticed many men with acne side effects had good results when they reduced their dose to 2 pills per day, versus the 4 pills recommended…

2.  Reduced libido—

This does not really does not make much sense. We actually saw an increase in estradiol (but not significantly); therefore, Novedex XT blunt aromatase activity, but is NOT a complete inhibitor. Therefore, even though estradiol increased, so did T levels such that the T/estradiol ratio is maintained. So, the libido issue is a non-issue.  Actually, Novedex should help to restore libido.

Many men are taking this Novedex as post-cycle therapy in an attempt to prevent rebound effects (though the name resembles a drug name intended for that purpose, the supplement is not marketed for the purpose of post-cycle therapy).  In any case, the so-called “side effects” of the Novedex in term of reduced libido are more likely due to a slump in natural T production.

3.  Is the fact that Novedex doesn’t completely inhibit aromatase a good thing?

The fact that Novedex is an incomplete inhibitor (but T/E is still robustly maintained) is good.

4.  I saw some posts alluding to Novedex blunting the sensitivity of androgen receptors; is there any truth to that?

…..This is possible but would not by any more of issue than those from AS. This is why Novedex should be cycled (per the manuturer’s recommendations)….not to stay on any longer than 8 weeks.

5.  Many men claimed it wouldn’t be useful simply for gaining mass and should only be used to minimize side effects post-cycle.  Is this true? 

It should be useful for gaining mass if someone was only taking this and not AS. Of course, those taking AS will get more mass than with Novedex, and providing a post-cycle regimen (such as with the drug Nolvadex) makes sense. But, in people who do NOT take AS and would like a boost in their T levels, then Novedex would certainly help with mass.

When I discussed the product with some friends who are taking AS, they commented that they "didn’t think that even a several-fold increase in circulating T could be beneficial for building muscle mass, given that the needed dose of supplemental androgens is dramatically higher."

With that in mind, it is also important to remember that taking just a little AS doesn’t make sense.  You must shut down natural androgen production (e.g. no balls) and then supplement on top of that amount to achieve supra-physiological levels of circulating androgens.  Since Novedex works by maximizing natural T production, it is not accurate to compare straight mg of "supplement" to a natural increase in circulating free testosterone.  Though supplementing with AS will produce greater muscular gains that an over the counter supplement, the two are not the same and cannot really be compared to one another.