DESCRIPTION

The HeartBar® is a medical food for the dietary management of cardiovascular disease. These ingredients are placed in a convenient and pleasant-tasting nutrition bar. The major active ingredient in the HeartBar is L-arginine, which is an amino acid required for the production of nitric oxide (NO). New 35 g bar or 8 oz drink contains L-arginine (3 g) and other amino acids, folate (200 µcg) and other B-complex vitamins, antioxidant vitamins E (200 IU) and C (250 mg), niacin (25 mg) and phytoestrogens. These nutrients are combined in a fruit, fiber, and soy protein-based nutrition bar. One HeartBar contains. HeartBar does not require a prescription but is to be used under the supervision of a health care professional.

COMPOSITION (original flavor) Heart Bar®

Nutrition Facts

Serving Size 1 Bar (35 g)
Servings                 1
Calories                 130
Fat Calories            20

Amount/Serving
%DV *
Total Fat 2 g
3%
  Saturated Fat 0 g
0%
0%
Sodium 90 mg
4%
Potassium 110 mg
3%
Total Carb. 19 g
6%
  Fiber 1 g
4%
  Sugars 10 g
 
Protein 10 g
20%
  L-arginine 3 g
 
* Percent Daily Values (DV) are based on a 2,000 calorie diet.

Vitamin C 192 mg • Vitamin E 200 IU Folic Acid 160 µg • Niacin 20 mg Vitamin B 6 2 mg • Vitamin B 12 3.6 µg Calcium 20 mg • Iron 1.44 mg

Not a significant source of Vitamin A, Biotin, or pantothenic acid.

Ingredients:   Soy protein isolate, toasted soy pieces, fructose, rice syrup, L-arginine hydrochloride, high fructose corn syrup, raisins, cookie pieces (wheat flour, sugar, canola oil, salt, sodium bicarbonate), natural and artifical flavor, oat fiber, ethylcellulose, ascorbic acid, maltodextrin, alpha-tocopherol acetate, cellulose, soy lecithin, soy isoflavones extract, modified food starch, partially hydrolyzed tapioca starch, sucralose, niacinamide, pyridoxine hydrochloride, salt, carrageeanan, folic acid, vitamin B 12 .

COMPOSITION Heart Bar® Orange Drink

Nutrition Facts

Serving Size (9 g)
1 Scoop
Servings Per
Container      32

Amount/Serving
%DV *
Calories 40
 
Total Fat 0 g
0%
Sodium 0 mg
0%
Total Carb. 5 g
2%
Protein 3 g
6%
  L-arginine 3 g
 
*Percent Daily Values (DV) are based on a 2,000 calorie diet.

Vitamin C 252 mg • Vitamin E 201 IU Folic Acid 200 µg • Niacin 26 mg Vitamin B 6 2 mg • Vitamin B 12 4.8 µg Calcium 0 mg • Iron 0 mg

Not a significant source of calories from fat, saturated fat, cholesterol, dietary fiber, sugars, calcium, and iron.

Ingredients:   L-arginine, citric acid, natural flavor, maltodextrin, alpha-tocopherol acetate, ascorbic acid, soy isoflavones extract, beta carotene added for color, sucralose, niacinamide, pyridoxine hydrochloride, vitamin B 12 , folic acid.

CLINICAL BACKGROUND

The major active ingredient of the HeartBar, L-arginine, is a semi-essential amino acid, and is the precursor for endothelium-derived nitric oxide (NO). NO is a potent vasodilator, and a major regulator of vasomotion and blood pressure. In addition, NO inhibits platelet aggregation, vascular smooth muscle proliferation and adherence of leukocytes to the vessel wall, key processes in atherosclerosis and restenosis.

Endothelium-derived NO activity is reduced in patients with cardiovascular disease; this abnormality contributes to insufficient blood flow, elevated blood pressure, as well as progression of disease. L-arginine has been shown to enhance the synthesis of NO. In humans, L-arginine improves vasodilation, enhances coronary and peripheral blood flow, and inhibits platelet aggregation.

The usual dietary intake of L-arginine is about 3 to 5 g/day, which in some cardiovascular conditions, may not be sufficient intake to maintain healthy NO levels. Two HeartBars/day provides an additional 6 g of L-arginine. The other active ingredients of the HeartBar contribute to the production of, or help prevent the breakdown of NO further augmenting the activity of NO.

The HeartBar has been tested clinically in several patient populations and shown to be effective in improving blood flow. In two separate studies of individuals with total cholesterol over 230 mg/dl (n=41 & n=39), two HeartBars/day restored flow-mediated vasodilation to normal within one and two weeks respectively (compared to no change with placebo).

In patients with peripheral arterial disease secondary to atherosclerosis (n=39), 2 HeartBars/day for 2 weeks improved pain-free walking distances by 66% (compared to placebo of 18%). In addition to this improvement in physical function, these patients experienced an improvement in quality of life scores as measured by the SF-36 Medical Outcomes Survey.

In patients with stable angina (n=36), 2 HeartBars/day for 2 weeks improved flow-mediated vasodilation. This was associated with a 22% increase in exercise time, 43% increase in work performance and a significant improvement in quality of life as measured by SF-36 and Seattle Angina Questionnaire scores.

In a study of diabetic patients (n=10), there was no change in pre- and post-prandial serum glucose measures or glycosylated hemoglobin during 3 months of HeartBar use at 2 bars/day.

PHARMACOKINETICS

Following the administration of 1 HeartBar, plasma arginine levels rise from 68±27 µM/L to a peak of 119±48 µM/L within one hour of ingestion. Arginine levels are maintained above those of individuals on an arginine-free diet for at least 8 hours after ingestion. A similar pattern of arginine levels is observed following the ingestion of a single HeartBar after a week of b.i.d. use. After 2 weeks, trough L-arginine levels are 42% higher than levels before HeartBar use. These arginine levels compare favorably with L-arginine administration by capsular form.

PRECAUTIONS

Diabetics

Each HeartBar is equal to 1 carbohydrate exchange. Although in a randomized study, there was no effect of regular use on daily fasting and post-prandial serum glucose or glycosylated hemoglobin measures, diabetics should monitor their blood glucose carefully while initiating regular use of the HeartBar. The effect of L-arginine on retinopathy is not known, therefore, those with diabetic retinopathy should not use HeartBar. The HeartBar® Orange Drink is especially designed for those on low sugar, low calorie diet. Contains no sugar, no carbohydrates and only 40 calories.

Renal Failure Patients

The HeartBar contains 10 g of protein. This amount of protein should be considered when determining total daily protein load.

Allergies

The base of the bar is of soy protein, which is generally considered hypoallergenic. The original flavor also contains a small amount of wheat flour, is low in gluten but not gluten-free. Therefore, individuals with allergies to wheat products or gluten intolerance should be cautious.

Sepsis

The hypotension associated with sepsis is, in part, mediated by excessive NO production. Such patients should not be given HeartBar.

ADVERSE REACTIONS

No serious adverse reactions have been demonstrated or reported in clinical trials or in the HeartBar Safety-In-Use study of over 2 years duration.

Minor adverse reactions are infrequent, generally related to gastrointestinal disturbances and appear unrelated to the L-arginine in the bar (Adverse events were just as common in the group given placebo bar). In a two-week study of the HeartBar, 4 of 41 individuals reported increased flatulence that resolved after several days of bar use. One of 41 individuals complained of increased frequency of bowel movements and soft stools. In a 10-week study of the HeartBar, 2 of 41 individuals reported dry mouth. A change in bowel habits was reported by 1 individual in each of the placebo and HeartBar groups. Use of HeartBar has not been associated with increased incidence of herpes cold sore formation.

The HeartBar is not indicated for individuals with co-existing conditions of diabetic retinopathy or neoplastic disease because the effect of L-arginine on the progression of these disorders is unknown.

ADMINISTRATION

Symptomatic or high-risk population

One HeartBar twice daily

At-risk population

One HeartBar daily

HOW SUPPLIED

Individually wrapped bars, cartons of 32 bars. Also available in 17g trial size.

Original Flavor                 NDC 63535-10102
Original/chocolate           NDC 63535-10112

Cranberry Flavor             NDC 63535-10202
Cranberry/yogurt            NDC 63535-10212

Peanut Butter Flavor        NDC 63535-10302
Peanut butter/chocolate   NDC 63535-10312

HeartBar Orange Drink
32 servings (individual)    NDC 63535-20202
32 serving Jar                 NDC 63535-20102

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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REFERENCES



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