Medical Foods: Products for the Management of Chronic Diseases

Morgan, RD Sarah L.; Baggott, Joseph E.

doi:10.1111/j.1753-4887.2006.tb00182.x

Cited by 19 publications

(5 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Genistein is considered a class 2 compound with low solubility and high permeability by the FDA's Biopharmaceutics Classification System. Though there are no formal requirements for this type of analysis of medical foods or supplements, it is important that fasting and fed PK and bioequivalence studies be performed, especially since medical foods have a statutory requirement to be indicated for a specific disease and must be administered under the direction of a physician [21]. Indeed, a fasting and fed PK study of genistein has been performed on the medical food Fosteum indicated for osteopenia/osteoporosis suggesting a minor, nonstatistical effect of food on absorption [31].…”

Section: Discussionmentioning

confidence: 99%

“…The FDA-regulated, prescription medical food [21], Fosteum, for the clinical dietary management of osteopenia and osteoporosis under physician supervision was formulated in collaboration with Squadrito and coworkers as previously described [11, 12]. The OTC bone supplement, Citracal Plus Bone Density Builder, is based on a bone support formula already on the market (Citracal) and uses literature support to justify the addition of genistein [11, 12].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The Steady-State Serum Concentration of Genistein Aglycone Is Affected by Formulation: A Bioequivalence Study of Bone Products

Bitto

Burnett

Polito

et al. 2013

BioMed Research International

View full text Add to dashboard Cite

An FDA-regulated, prescription medical food (Fosteum; 27 mg natural genistein, 200 IU cholecalciferol, 20 mg citrated zinc bisglycinate (4 mg elemental zinc) per capsule) and an over-the-counter (OTC) supplement (Citracal Plus Bone Density Builder; 27 mg synthetic genistein, 600 mg elemental calcium (calcium citrate), 400 IU vitamin D3, 50 mg magnesium, 7.5 mg zinc, 1 mg copper, 75 μg molybdenum, 250 μg boron per two tablets) were compared to a clinically proven bone formulation (27 mg natural genistein, 400 IU cholecalciferol, 500 mg elemental calcium (calcium carbonate) per tablet; the Squadrito formulation) in an 8-day steady-state pharmacokinetic (PK) study of healthy postmenopausal women (n = 30) randomized to receive 54 mg of genistein per day. Trough serum samples were obtained before the final dose on the morning of the ninth day followed by sampling at 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hrs. Total serum genistein, after β-glucuronidase/sulfatase digestion, was measured by time-resolved fluorometric assay. Maximal time (T max), concentration (C max), half-life (T 1/2), and area under the curve (AUC) were determined for genistein in each formulation. Fosteum and the Squadrito study formulation were equivalent for genistein T max (2 hrs), C max (0.7 μM), T 1/2 (18 ± 6.9 versus 21 ± 4.9 hrs), and AUC (9221 ± 413 versus 9818 ± 1370 ng·hr/mL). The OTC supplement's synthetically derived genistein, however, showed altered T max (6 hrs), C max (0.57 μM), T 1/2 (8.3 ± 1.9 hrs), and AUC (6474 ± 287 ng·hr/mL). Differences in uptake may be due to multiple ingredients in the OTC supplement which interfere with genistein absorption.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Steady-State Serum Concentration of Genistein Aglycone Is Affected by Formulation: A Bioequivalence Study of Bone Products

Bitto

Burnett

Polito

et al. 2013

BioMed Research International

View full text Add to dashboard Cite

show abstract

“…467 Medical foods are not drugs and, thus are not subject to any regulatory requirements that apply to drugs. Thus, medical foods do not have to undergo premarket review or approval.…”

Section: Medical Foodsmentioning

confidence: 99%

Food and Dietary Supplement Package Labeling—Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations

Brody¹

2015

Comp Rev Food Sci Food Safe

View full text Add to dashboard Cite

Package labels for foods and dietary supplements must conform with Title 21 of the Code of Federal Regulations. This review provides guidance for the content and format of labels, including for the Nutrient Facts panel and Supplement Facts panel, and for drafting structure/function claims, health claims, and nutrient content claims. Also provided is guidance on how to refrain from drafting disease claims. Inappropriate disease claims on a food or dietary supplement compels FDA to review the product as a drug. Disease claims is the most common source of complaint in FDA's warning letters. This review makes use of all of FDA's warning letters that were published over a 14-y span (2002to 2015). This is the first comprehensive review on package labels to make use of FDA's warning letters as a source document.

show abstract

“…41 Through a 5-step process, AAB prevents deamination by the liver, promotes uptake into the appropriate neuron, conversion to the neurotransmitter, releases the adenosine brake, and prevents the attenuation of effect. Medical foods 42 are specially formulated products for the specific dietary management of a disease or condition that has distinctive nutritional requirements. Nutrient imbalances caused by pain leads to metabolic disequilibrium.…”

Section: Introductionmentioning

confidence: 99%

Reduction in Pain and Inflammation Associated With Chronic Low Back Pain With the Use of the Medical Food Theramine

Shell

Pavlik

Roth

et al. 2016

American Journal of Therapeutics

View full text Add to dashboard Cite

Management of chronic back pain is a challenge for physicians. Although standard treatments exert a modest effect, they are associated with narcotic addiction and serious side effects from nonsteroidal antiinflammatory agents. Moreover, neurotransmitter depletion from both the pain syndrome and therapy may contribute to a poor treatment outcome. Neurotransmitter deficiency may be related both to increased turnover rate and inadequate neurotransmitter precursors from the diet, particularly for essential and semi-essential amino acids. Theramine, an amino acid blend 68405-1 (AAB), is a physician-prescribed only medical food. It contains neurotransmitter precursors and systems for increasing production and preventing attenuation of neurotransmitters. A double-blind controlled study of AAB, low-dose ibuprofen, and the coadministration of the 2 agents were performed. The primary end points included the Roland Morris index and Oswestry disability scale. The cohort included 122 patients aged between 18 and 75 years. The patients were randomized to 1 of 3 groups: AAB alone, ibuprofen alone, and the coadministration of the 2 agents. In addition, C-reactive protein, interleukin 6, and plasma amino acid concentrations were measured at baseline and 28 days time points. After treatment, the Oswestry Disability Index worsened by 4.52% in the ibuprofen group, improved 41.91% in the AAB group, and improved 62.15% in the combination group. The Roland Morris Index worsened by 0.73% in the ibuprofen group, improved by 50.3% in the AAB group, and improved 63.1% in the combination group. C-reactive protein in the ibuprofen group increased by 60.1%, decreased by 47.1% in the AAB group, and decreased by 36% in the combination group. Similar changes were seen in interleukin 6. Arginine, serine, histidine, and tryptophan levels were substantially reduced before treatment in the chronic pain syndrome and increased toward normal during treatment. There was a direct correlation between improvement in amino acid concentration and treatment response. Treatment with amino acid precursors was associated with substantial improvement in chronic back pain, reduction in inflammation, and improvement in back pain correlated with increased amino acid precursors to neurotransmitters in blood.

show abstract

Medical Foods: Products for the Management of Chronic Diseases

Cited by 19 publications

References 17 publications

The Steady-State Serum Concentration of Genistein Aglycone Is Affected by Formulation: A Bioequivalence Study of Bone Products

The Steady-State Serum Concentration of Genistein Aglycone Is Affected by Formulation: A Bioequivalence Study of Bone Products

Food and Dietary Supplement Package Labeling—Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations

Reduction in Pain and Inflammation Associated With Chronic Low Back Pain With the Use of the Medical Food Theramine

Contact Info

Product

Resources

About