DESCRIPTION

ProNutra is a dietary protein supplement containing Immunocal which is prepared using a proprietary microfiltration process to produce a highly undenatured whey protein product. ProNutra furnishes all of the amino acids and is a good source of nitrogen for replacing nitrogen losses that occur in patients with pressure ulcers. This process of preparation also ensures that ProNutra contains a rich source of bio-available cystine ¹ (two molecules of cysteine linked by a disulfide bond - "bonded cysteine") to promote positive nitrogen balance for minimizing muscle breakdown and rebuilding lean body mass (LBM). Cystine is required to synthesize glutathione which (1) is the cell's major antioxidant and (2) plays a vital role in many cell cycle related events that are needed during tissue repair such as DNA synthesis, protein synthesis and production of growth factors. Glutathione is also vital for maintaining normal functioning of the immune system

PHARMACOLOGY

• The bioactive protein component of ProNutra is Immunocal, a highly undenatured whey protein isolate. Whey protein isolates have the highest biological value (BV), greatest protein efficiency ratio (PER), and highest amino acid score (AAS) of all proteins ² . ProNutra provides all of the essential amino acids as well as those such as arginine, cystine and glutamine that are essential in stressed patients who cannot synthesize sufficient amounts to meet demands.
• ProNutra is rich in cystine (bonded cysteine). It is rare in foodstuffs.
• ProNutra is clinically proven to raise intracellular glutathione ³ .
• Animal experiments have shown that ProNutra enhances the response of the immune system and exerts an anticancer effect ¹ .
• ProNutra is clinically proven to increase body weight ^4,5 .
• ProNutra has a significant quantity of branch chain amino acids (BCAA) (leucine, isoleucine and valine) ⁶ .
• ProNutra contains zinc, omega 3 & 6 fatty acids, vitamins A, C & E.

INDICATIONS AND USAGE

ProNutra is designed for individuals with, or at risk for developing, pressure ulcers, and for individuals who are malnourished and/or have protein energy malnutrition.

CONTRAINDICATIONS

ProNutra® is contraindicated in individuals who develop or have known hypersensitivity to specific milk proteins.

PRECAUTIONS

Each bottle of ProNutra® contains 18 grams of protein. Physicians may need to consider this fact when calculating their daily protein intake for patients on a protein-restricted diet. Because ProNutra contains less than .07% lactose, lactose-intolerant individuals tolerate ProNutra well. When used long term, physicians should note that ProNutra contains 9 mg of zinc per serving.

WARNINGS

Patients undergoing immunosuppressive therapy should discuss the use of ProNutra with their health professional.

ADVERSE REACTIONS

Gastrointestinal bloating and cramps may occur if ProNutra is not sufficiently rehydrated. Transient urticarial-like rash may occur in rare individuals undergoing severe detoxification reaction. Rash abates when ProNutra intake is stopped or reduced.

OVER DOSAGE

None Reported.

DOSAGE AND ADMINISTRATION

For high risk patients susceptible to muscle wasting, stage I & II pressure ulcers, PEM, protein malabsorption, or compromised immune systems: 1 serving (1 bottle) per day is recommended. Stage III & IV pressure ulcers or patients with severe PEM: 2 servings (2 bottles) per day are recommended. For long term maintenance: 1 serving (1 bottle) 2 or 3 times per week according to patient response. ProNutra may be added to oral and tube-administered enteral products.

Reconstitution

ProNutra® is a powder with a pleasant citrus flavor, designed to mix with water. DO NOT heat or use a hot liquid to rehydrate the product or use a high-speed blender for reconstitution. If refrigerated after mixing, it will remain bioactive for up to 12 hours after mixing.

HOW SUPPLIED

ProNutra comes in individual, disposable, plastic bottles containing 37 grams per serving.

REFERENCES:

1. Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 2000;20(6C):4785-92.
2. Reference Manual for U.S. Whey Products, 2 ^nd ed., U.S. Diary Export Council, 1999.
3. Lands LC, Grey VL, Smountas AA. Effect of supplementation with a cysteine donor on muscular performance. J Appl Physiol.1999;87:1381-5.
4. Bounous G, Baruchel B, Gold P. Whey Proteins as a food supplement in HIV-seropositive individuals. Clin Invest Med 1993; 16: 204-209.
5. Pacheco L, Goldart J, Guilford T, Kwyer T, Kongshavn, PAL. Bioactive, cysteine-rich dietary supplement alleviates gastrointestinal side-effects, with associated weight gain and marked improvement in HAART adherence in AIDS patients. Presented at 2002 International Meeting of the Institute of Human Virology, September 9-13, 2002, Baltimore, Maryland.
6. Ha E, Zemel, MB. Functional properties of whey, whey components, and essential amino acids: mechanisms underlying health benefits for active people. J Nutr Biochem 2003;14:251-258.
7. Clarke RH et al. Nutritional treatment for acquired immunodeficiency virus-associated wasting using beta-hydroxy-beta-methylbutyrate, glutamine and arginine: a randomized, double-blind, placebo-controlled study. JPEN 2000; 133-139.
8. Stechmiller JK. Roundtable 107, Wound healing and arginine. A.S.P.E.N. Nutrition Week, Las Vegas, February 9, 2004.

Manufactured by Immunotec

Medical Corp.

Distributed by: NuMedTec

Tel 877-687-2277

www.pronutra.us