NovaHue Product questions:

 

We know Novahue products have a lot of carotenoid rich fruits and vegetables, but what are the amounts of the “other ingredients” not carotenoid based listed?

The amounts of “other ingredients” vary by product:

  • NovaHue Cardio contains Bovine Gelatin, Glycerol, Water, Caramel color and Annatto extract color ~ 200 mg
  • NovaHue Prostate contains Bovine Gelatin, Glycerol, Water, Caramel color and Annatto extract color ~ 415 mg
  • NovaHue Menopause contains Cellulose Derivatives Microcrystalline Cellulose, Magnesium

Stearate, Silicon  Dioxide, and Titanium Dioxide ~ 85 mg.

 

 

Are the products gluten, dairy, etc. free?

NovaHue product features are created by focusing on what works best with the product’s targeted condition

benefits and vary by SKU:

NovaHue Prostate and NovaHue Cardio soft gels are, nondairy, gluten free, yeast free, non BSE, starch and sugar free.

NovaHue Menopause capsules are , nondairy, gluten free, yeast free, and non BSE.

 

 

Are the capsules and or soft gels vegetarian?

Though the capsule shell is vegetarian, the capsules contain vitamin D3 from sheep’s wool. The soft gels are not vegetarian.

 

Are the products Kosher, Halal?

At launch will not be either Kosher or Halal. The plans for all products are to be certified Kosher and Halal, but

Timing here is TBD.

 

 

Are all ingredients non-GMO? Is there a statement from NovaHue that we can provide to HCPs stating this?

Yes. We have a general statement for the capsules including non-GMO, BSE free etc. All NovaHue product documents contain the following.

Is not manufactured from GM raw materials and therefore is not subject to labeling under the EU directives EC 1829/2003 (Regulation on genetically modified food and feed) and EC 1830/2003 (Regulation concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms).

 

What is the source of the phytosterols? Is this why there is soy in the product?

Most phytosterols are coming from tomato extract, but for standardization purposes we use VEGAPURE 95 that is similar in its structure to the tomato’s phytosterols. VEGAPURE 95 contains phytosterols from highly refined soybean oil.

 

What is the difference between lycopene and standardized tomato extract?

Yes. Standarized tomato extract and Lycopene are different. Tomatoes extract is the oil fraction that is being extracted as a whole from (in the case of the LycoRed proprietary process) FRESH tomato pulp.  It contains

 

many natural molecules, some can be identified and standardized, some can just be identified while others can’t

even be identified.

 

Lycopene, is a member of the carotenoids group of molecules. It is a single molecule that exists in the tomato and in other natural sources. Lycopene is one of MANY molecules that exists in tomatoes.

 

Why is titanium dioxide included in Menopause?

 

Due to the color of the pre-mix that is naturally combining light colored and dark colored particles, we are using a

WHITE vegetarian capsule. The titanium dioxide is used in the coloration of the WHITE capsules.

 

 

What is the utility of the mixed tocopherols in Menopause?

Mixed tocopherols is not a part of the MENOPAUSE composition.  NovaHue Menopause contains Cellulose

Derivatives Microcrystalline Cellulose, Magnesium Stearate, Silicon  Dioxide, and Titanium Dioxide ~ 85 mg.

 

Why is only Vitamin D3 in Menopause? How do we position this when Dr. Weiss has been saying that D2 and D3 are both necessary ingredients in Oxisol?

Vitamin D comes in two forms. Vitamin D2 is obtained from the UV irradiation of the yeast sterol ergosterol. Vitamin D3 is synthesized in the skin and is present in oil-rich fish such as salmon etc. Chemically, the various forms of vitamin D are secosteroids; i.e., steroids in which one of the bonds in the steroid rings is broken. The structural difference between vitamin D2 and vitamin D3 is in their side chains. The side chain of D2 contains a double bond between carbons 22 and 23, and a methyl group on carbon.

 

The biological fate for producing 25(OH)D from vitamin D2 is expected to be the same as for 25(OH)D3, although some controversy exists over whether or not D2 can fully substitute for vitamin D3 in the human diet.

 

Both vitamin D2 and vitamin D3 are used for food fortification and in vitamin D supplements.

 

The recent Endocrine society clinical practice guideline suggests using either vitamin D2 or vitamin D3 for the treatment and prevention of vitamin D deficiency. Holick et al  Endocrine Society Clinical Practice Guideline J Clin Endocrinol Metab, July 2011, 96(7):1911–1930

 

Is there any concern with zinc toxicity and the use of Prostate since 1 soft gel contains 100% of the % Daily Value?

We tested Zn toxicity in in-vitro system with LNCaP prostate cancer cells. No toxicity was detected on the synergistic effect of combination of various phenols and carotenoids in stimulation of the antioxidant response element transcription factor.

 

As relevant, the U.S. Food and Drug Administration (FDA) deems zinc generally recognized as safe

(GRAS) when it’s manufactured properly.

 

 

The average zinc intake tends to be considerably less than the RDA for older adults. A reduced capacity to absorb zinc, increased likelihood of disease states that alter zinc utilization, and increased use of drugs

that increase zinc excretion may all contribute to an increased risk of mild zinc deficiency in older adults. The major consequence of long-term consumption of excessive zinc is copper deficiency. In order to prevent copper deficiency, the U.S. Food and Nutrition Board set the tolerable upper intake level (UL) for adults at 40 mg/day, including dietary and supplemental zinc.

*Food and Nutrition Board, Institute of Medicine. Zinc. Dietary reference intakes for vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. Washington, D.C.: National Academy Press; 2001:442-501.

 

Dr. Weiss included both alpha and gamma tocopherols so as not to deplete the gamma tocopherols. How do we position Prostate with only alpha tocopherols in light of this?

Prostate contains vitamin E with mixed tocopherols from tomato.

 

NSI/PHL questions

 

Do we disclose the manufacturers of NovaHue?

No.

 

 

Do we have cGMP statements for them?

Yes.

 

How heavily will we promote the use of blister packs when all NSI products are sold in bottles?

Minimal focus compared to all NovaHue product and brand’s point of difference.

 

 

How heavily will we promote the use of a once-a-day dose when NSI products are often taken throughout the day?

Uber-heavily. Technology is being used (concentration, delivery systems etc.) to minimize the number of servings per day. It is fact the lower the number of servings per day that is required from the patient to take the higher the long-term compliance.

 

“Gene expression” was listed as a consideration for taking Prostate. Will PHL genetic testing be an available marker for the Assess portion, or why is this noted? Genetic testing may support taking Prostate in healthy men.

A recent study (Double-blind, randomized, placebo-controlled) show that proprietary tomato extract modulates prostate gene expression in normal prostate tissue (Magbanua et al, PLoS ONE , 2011). Gene expression in morphologically normal prostate tissue taken from non-aggressive prostate cancer patients, (n= 84 ) were oral supplemented with proprietary tomato extract for 3 months. cDNA microarray analysis revealed the modulation of at least two important regulatory pathways for the progression (and thus prevention) of prostate cancer:

The Nrf2-mediated oxidative stress response pathway

Modulation of androgen metabolism

 

In this time point PSA is the only relevant test both for prostate cancer and for BPH as the increased amount of tissue (cancerous or non-cancer as in BPH) secrete more PSA which is detected in the blood of people having any of these prostate conditions.

 

At the moment we are not aware of any other specific test. In the future we should explore this issue. Since BPH has an important inflammatory etiology perhaps the analysis of inflammatory markers such as CRP or specific cytokines should be considered.

 

Will the network of registered dieticians (once established) be available to CSE or

HCPs to answer questions about the products/ingredients like KOLs are?

TBD

 

 

When will the Test Resource Guide for the NeuroCardio profiles be completed?

NeuroScience…

 

 

Do novahue products affect P450 enzymes?

 

We found that cyp24 is inhibited by carnosic acid and curcumin. This is increasing the blood concentration of 25 hydroxy vitamin D3 level.

 

Are there any drug interactions or contraindications for novahue products?

TBD

 

 

What precautions are necessary to avoid the pro-oxidant actions of lycopene?

The pro-oxidant action of lycopene occur at high concentrations above 2 μM. Unlike β-carotene and some other carotenoids, lycopene concentrations in human blood are not reaching such high concentrations even with massive supplementation.

 

Which micronutrients, e.g. iron, vitamin C do novahue products naturally contain, and how much?

The tomato contains about 160-240 mg/kg Vitamin C, 4-5 mg/kg Iron and other micronutrients such as manganese, folate zinc and copper. Novahue tomato extract naturally contains all the tomato natural nutrients soluble in the oleoresin.

 

Should novahue products be taken with or without food, why?

With food. The bio availability of carotenoids is improved.

 

 

What kind of therapy adjustments for Cardio will we offer on retests?

TBD

 

 

What kind of therapy adjustments for Menopause will we offer on retests?

TBD

 

 

When/why should we recommend Menopause over FemFlavone?

Menopause contains 98% pure non-soy genistein formulated as slow release in a one a day dosage. A review of current literature indicates that the aglycone genistein appears to be the most effective isoflavone in preserving bone health. An evaluation of published studies until 2006 provided five studies, involving a total of 177 treated participants, where the study product provided more than 15 mg

genistein per treatment. Each of these studies consistently reported a statistically significant decrease in vasomotor symptoms (1). Isoflavone supplements providing more than 18.8 mg of genistein (the median for all studies) were more than twice as potent at reducing hot flash frequency than lower genistein supplements (2).The 40% isoflavones in FemFlavone are from soy and unlikely to reach such doses of genistein. In addition Menopause contains lycopene which adds to the bone health effect and supports the genistein safety. Potential biomarkers should be discussed.

 

What kind of therapy adjustments for Prostate will we offer on retests?

TBD

 

 

Are elevated levels of PSA sufficient to warrant the product?

 

In this time point PSA is the only relevant test both for prostate cancer and for BPH as the increased amount of tissue (cancerous or non-cancer as in BPH) secrete more PSA which is detected in the blood of people having any of these prostate conditions.

The statements on this site have not been evaluated by the FDA. Our products are not intended to diagnose, treat, cure, or prevent any disease.