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    John Williams, Ph.D., has degrees in archaeology and anthropology. His research and fieldwork has focused on the Paleolithic and Neolithic of the “Old World”, which basically means the Stone Age of Europe, Africa and Asia. John has always had an interest in nutrition, which actually works quite well within prehistoric studies, because our past was one big food quest.

    CB: John, you have an interesting background. Now, let’s talk about North American nutrition for gaining muscle and losing fat. What’s new in nutrition
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    approaches for athletes, fat loss, and health?

    JW: I try to stay current with nutritional literature for my own interests, but I don’t want to get in over my head with respect to performance nutrition for athletes. Others like John Berardi, who make a living in this field, would be better suited to discuss the latest and greatest approaches.

    I have been reading a lot about fish oil lately, and its positive effects for both overall health and positive effects on body composition. Adding a little fish oil in your d
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    iet is one of the easiest ways to boost your metabolism. Recent studies have shown that as little as 3 grams of combined EPA and DHA (both omega-3 fatty acids) can speed your metabolic rate by about 400 k/cal per day.

    These long-chain fatty acids also have a host of great health benefits, including brain health, antioxidant and anti-inflammatory effects, better sugar management, and more. So by doing something as simple as popping a couple of fish oil caps with each meal, you can live a longer, leaner, brainier life!
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.



    CB: John, do you have any other superfoods that you think absolutely must be in everyone’s diet?

    JW: Fish oil would be one, for the reasons given in the previous answer. Another must-have in everyone’s diet is spinach. Among the leafy greens, spinach offers some of the best benefits in terms of vitamins and micronutrients. It’s chock full of important phytochemicals, vitamin A, B vitamins, calcium, phosphorous, iron, folate and potassium.

    But that’s not all! Spinach is also one of the most alkaline foods availa
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    le, which means that it helps neutralize acidic foods that are common in high protein diets. So by adding more spinach to our diet, we can alleviate a lot of stress on our muscles and bones.

    I also think that most people could benefit from simply increasing their daily intake of fresh veggies and fruit. I’m not talking fruit juice or even V8, but the real deal: every color and variety of vegetables and fruit that you know of. This isn’t groundbreaking news, but fresh fruit and vegetables provide an enormous amount of
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    benefits, ranging from anti-cancer properties to improved blood lipids to increased energy.

    Another food of the grain variety that I think many people would benefit from is quinoa (pronounced “KEEN-oowa”). It’s a South American grain domesticated by the predecessors of the Incas that grows on a plant that looks a lot like spinach. So it’s a “leafy grain” rather than a grass grain such as wheat and corn.

    Quinoa is gluten-free, and contains none of the allergens common to grains from the grass family such as wheat, r
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    ye, barley, oats, and corn. Furthermore, quinoa contains lysine, an amino acid deficient in many grains, making it a complete protein. Quinoa is also an excellent source of calcium, magnesium, iron, phosphorus, and B vitamins. It’s one of the good guys in the grain family, so pick some up next time your in a whole foods-type market.

    CB: Are there any nutrition-fat loss myths that you would like to clear up?

    JW: With respect to the recent swing of the pendulum to low-carb diets, it seems that a lot of people used
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    that as an excuse not to eat vegetables. Low carb diets certainly have their benefits for many people, but there is absolutely no excuse for avoiding a big serving of broccoli for fear of a few extra carbs. Unless it’s drenched in margarine, broccoli (or insert any leafy green here) can do nothing but good.

    CB: Thanks John. I believe that eating large amounts of fibrous vegetables is one of the keys to getting, and staying lean. How do you think someone should eat to get lean? Does eating to stay lean differ from get
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ing lean?

    JW: Let me address the last question first: The ideal situation is to learn how to eat to maximize both your performance and health goals, and simply eat more or less according to how much muscle you want to gain versus how much fat you want to lose. In other words, eating to get lean and eating to stay lean would differ only in overall calories consumed.

    There are certainly cases when someone would benefit from a more extreme diet like Atkins to remove years of overindulgence and bad dietary choices, b
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    ut the danger is always there that the person will rebound unless they learn how to eat properly.

    So, how do we eat to get (and stay) lean? I have a few simple rules, like caloric balance, sufficient protein, lots of whole veggies and fruit, no processed carbs outside of the post-workout window, balanced fats – and let’s not forget the other side of the coin: activity (preferably a mixture of heavy lifting and some sort of cardio). There are certainly a lot of details within those rules, and tricks to make it work fo
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    r your individual goals, but it all boils down to those simple rules.

    My good friend John Berardi has spoken extensively on how some people have a tendency to replace hard lifting, and even a healthy diet, with the acquisition of knowledge. These folks have mediocre or even poor physiques, yet all of their time is spent in pursuit of the holy grail of fitness and nutrition knowledge. How many carbs does that 5.8 oz serving of artichoke have, and how will this affect insulin levels? Who cares, just eat the darn thing
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    and go lift some heavy weights! The fact remains that it takes hard work in the gym to get a good physique, in addition to knowledge about how to lift and what to eat.

    Obviously, the road goes both ways, and there are still hordes of folks out there that don’t know an artichoke from a Twinkie, but the key is to not get lost in the minutia and neglect what really matters: a balanced diet and hard training.

    CB: You have a Ph.D. in archaeology, and you’ve researched evolution and nutrition, correct? What lessons have y
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    u learned from your studies? How have we evolved to eat? Does it differ geographically?

    JW: That’s right, Craig. We archaeologists love to make fun of trendy “Paleo-diets” and books like Neanderthin. There was no single paleo-diet; people during the Paleolithic ate whatever they could get their hands on, and what they ate depended upon what region of the world they were living. I recently talked with Erik Trinkaus, a paleoanthropologist and the world’s premier expert on Neanderthals, and he summarized his thoughts
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    on the matter by saying “the Neanderthal world was in no way idyllic. These folks had hard lives and died young, and their version of a paleo-diet was to eat whatever didn’t eat them first”.

    That being said, there are certain lessons we can learn about our past that can help us understand why we’re having so many diet-related problems today.

    I have a few simple lessons from the archaeological record concerning nutrition:

    1) Eat more protein and less of the other stuff.

    In a nutshell, we’ve been eating a diet
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    rich in plants, fish, and animals for millions of years now. There have been many studies published in peer-reviewed journals demonstrating that getting your protein consumption over the 10-15% national average has positive benefits in terms of body composition and blood lipids.

    2) Get your carbs from their source.

    Paleolithic people didn’t have Krispy Kreme, otherwise they’d be as fat as your average sugar junkie today. Outside of the post-workout window, when simple sugars and fast-absorbing protein is desir
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    able, we can all benefit from avoiding all of the hyper-processed food that litters the aisles of our grocery stores, and opting instead for foods in their original, unadulterated state. If you took a look in my kitchen cabinets, you’d see a variety of whole grains and legumes: quinoa, barley, steel-cut oats, oat bran, wheat bran, lentils, split peas, and chick peas.

    3) Eat your veggies and fruit.

    It’s clear that we’ve evolved to reap the benefits of a diet rich in veggies and fruit, judging from the preserved
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    emains of literally hundreds of varieties of wild plant foods at sites such as Ohalo II, a 23,000 year old fishing camp on the Sea of Galilee. I never realized how many veggie haters there are until I started trying to get my friends and family to eat more of them.

    After months of avoidance, I finally convinced a good friend of mine to increase his vegetable intake. He was by no means fat, but he was getting frustrated with a slowly growing tire around his waist. I gave him some recipes to make things like broccoli a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nd spinach more palatable, and he eventually took my advice. After this change, he is leaner than he has ever been in his life, and he is constantly telling me how much energy he has.

    4) Balance those fats.

    This is an issue that really ties-in with my prehistoric research. It’s interesting to note how skewed the fatty-acid profile of the modern western diet is towards saturated fat and omega-6’s, at the expense of monounsaturated and omega-3’s. In our not so distant past, this wouldn’t have been possible, beca
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    use wild animals don’t store so much overall fat, and they weren’t fed corn meal to inflate the omega-6’s in their adipose tissue. Also, our ancestors got a lot more omega-3’s from wild plants, animals, and fish. All in all, it looks like we’ve evolved on a diet with a good amount of monounsaturated fats from nuts, seeds, and animals, as well as a nearly equal amount of omega-6’s to omega-3’s. Tons of studies have shown that an inflated omega-6 to omega-3 ratio is contributes to heart disease, diabetes, and obesity
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    , while getting a more balanced fatty-acid profile, including sufficient monounsaturated fats, actually protects against these health problems. What’s the solution? Free range meat and eggs are always a good choice, and when you’re buying meat from feedlot animals, go for the leanest varieties. Throw-out any corn oil in your cupboards and replace it with olive oil, and then eat plenty of fish and/or supplement with flax and fish oil.

    CB: Thanks John. Excellent info. Simple guidelines. Focus on whole, natural foods


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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