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). Each 50g bar 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 13 g of protein (10g of soy protein), 27 g of carbohydrate (20 g of sugars, 3 g of fiber), 2.5 g of fat (no saturated fat, 0 mg of cholesterol), and 190 calories. HeartBar does not require a prescription but is to be used under the supervision of a health care professional.
High fructose corn syrup, soy protein isolate, fructose, toasted soy pieces, raisins, vanilla cookie pieces (including wheat flour), L-arginine HCl, natural and artificial flavors, oat fiber, D-alpha-tocopherol acetate, sodium ascorbate, dipotassium phosphate, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin.
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.
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.
Diabetics
Each HeartBar is equal to 2 carbohydrate exchanges. 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 contains 13 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.
The hypotension associated with sepsis is, in part, mediated by excessive NO production. Such patients should not be given HeartBar.
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.
Symptomatic or high-risk population
One HeartBar twice daily
At-risk population
One HeartBar daily
Individually wrapped bars, cartons of 16 and cases of 64. Also available in 20g trial size.
Original Flavor
Individual Bars NDC 63535-10102
By Carton NDC 63535-10103
By Case NDC 63535-10104
Cranberry Flavor
Individual Bars NDC 63535-10302
By Carton NDC 63535-10303
By Case NDC 63535-10304
Individual Bars NDC 63535-10502
By Carton NDC 63535-10503
By Case NDC 63535-10504
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A. J. Maxwell, Nutrition & MD 25 , 1-4 (1999).
A. J. Maxwell, M. P. Zapien, B. A. Anderson, P. H. Stone, J Am Coll Cardiol 35 , 408A (2000).