Long Term Care FAQs

1. What are Medical Foods?
2. Are Medical Foods the same as dietary supplements?
3. Are Medical Foods safe for the geriatric population?
4. What products might be appropriate for the geriatric population?
5. Is there clinical data?
6. What are the side effects?
7. How are Medical Foods regulated?
8. What makes Physician Therapeutics’ (PTL) Medical Foods different from amino acids and other Medical Foods?
9. Why are neurotransmitters important?
10. Can Medical Foods be prescribed as an adjunct to a pharmaceutical?
11. Is there a chart of recommended dosing for Sentra AM, Sentra PM and Theramine?
12. If the patient is taking multiple Medical Foods, can they be taken at the same time?
13. Can Physician Therapeutics’ Medical Foods be taken with food?
14. Are the Medical Foods gluten‐free?
15. Can nursing staff receive samples of the Medical Foods directly?

 

1: What are Medical Foods?

A Medical Food is defined by the FDA as a food product that is intended for the dietary management of a disease or condition associated with specific nutrient requirements.  In a Long Term Care setting they must be given under physician supervision and administered enterally by a qualified healthcare provider. 

2: Are Medical Foods the same as dietary supplements?

No. Medical Foods are not dietary supplements. Medical Foods must be administered under physician supervision just like any other prescription drug. Also, Medical Foods must make disease claims and dietary supplements cannot. The term Medical Food is a distinct category established by the FDA and must meet strict regulatory requirements.

3: Are Medical Foods safe for the geriatric population?

Yes.  Medical Foods are safe for the geriatric population. All of the ingredients in Medical Foods are taken from FDA’s Generally Recognized As Safe (GRAS) list. Medical Foods are not chemically synthesized nor metabolize like drugs. There have been no reports of gastrointestinal bleeding, damage to the liver or adverse cardiovascular events from the use of Physician Therapeutics’ Medical Foods.

4: What products might be appropriate for the geriatric population?

There are at least 3 products that may have particular clinical utility in this group: 1) Sentra AM© which is prescribed for patients to help improve cognition and fatigue associated with specific nutritional deficiencies, 2) Sentra PM© to help manage sleep disorders associated with specific nutritional deficiencies, and 3) Theramine© for the dietary management of pain syndromes and inflammation without significant gastrointestinal or other side effects.

5: Is there clinical data?

Each Medical Food has a product monograph based on extensive peer‐reviewed literature. Currently there are a number of double‐blind clinical trials that have been completed  for Physician Therapeutics’ Medical Food Products, and several more studies that are ongoing. All double‐blind trials have been submitted to www.clinicaltrials.gov. Several crossover trials have also been completed and there is also ample clinical outcomes data. You may request copies of the trials from Physician Therapeutics.  For more Information go to: www.ptlcentral.com

6: What are the side effects?

The side effects of Physician Therapeutics’ Medical Foods are minor and temporary, ranging from dry mouth and nausea to mild upset stomach. Because the ingredients in these products are part of a propietary blend consisting of milligram quantities of amino acids and other GRAS substances, the side effects are comparable to food intolerance.

7: How are Medical Foods regulated?

All Medical Foods are regulated by the FDA. Because all the ingredients are taken from the Generally Recognized As Safe (GRAS) list, the safety of Medical Foods is already established and does not need to go through premarket review or approval by FDA. Physician Therapeutics’ Medical Foods are held to the same efficacy standard of pharmaceuticals and undergo a rigorous, methodological, and peer reviewed clinical efficacy testing process. 

8: What makes Physician Therapeutics’ (PTL) Medical Foods different from amino acids and other Medical Foods?

Physician Therapeutics’ Medical Foods are obtained only by prescription and use a patented technology containing amino acids and other ingredients that not only produce neurotransmitters but utilize them in an efficient way.

9: Why are neurotransmitters important?

A: Neurotransmitters are responsible for all the cell communication throughout our body that affects heart rate, blood pressure, weight, inflammation, sleep, cognition, pain and mood. Any depletion of neurotransmitters can occur because of disease, age, diet, environmental toxins, genetics and excessive pharmaceutical drug use.

10: Can Medical Foods be prescribed as an adjunct to a pharmaceutical?

Yes. Medical Foods can be administered with pharmaceutical drugs under the supervision of a physician.  It is suggested that physicians monitor the dose of the pharmaceutical when co‐administering a medical food and a pharmaceutical. Clinical trials indicate that the lowest FDA approved dose of  a pharmaceutical  administered with a Medical Food can yield statistically relevant clinical results (Shell et al. Am. Journal Therapeutics, 2010).

11: Is there a chart of recommended dosing for Sentra AM, Sentra PM and Theramine?

Yes. See medical food product information at http://www.ptlcentral.com/medical-foods-products.php

12: If the patient is taking multiple Medical Foods, can they be taken at the same time?

Yes. The Medical Foods can be given at the same time, but if possible, it is recommended that each Medical Food is taken at least 15 minutes apart. For example, the patient could take 2 capsules of Sentra AM in the morning and about 15‐30 minutes later, take 2 capsules of Theramine to manage pain and inflammation.

13: Can Physician Therapeutics’ Medical Foods be taken with food?

It is recommended that the Medical Foods be taken 15‐30 minutes before or after eating food. Doing so helps to avoid competition for amino acids found in other food.

14: Are the Medical Foods gluten‐free?

Yes. All of the products are gluten‐free. Gluten is a protein usually found in wheat, barley, rye or oats. We can provide a Certificate of Analysis for each of our Medical Foods showing the complete list of ingredients.

15: Can nursing staff receive samples of the Medical Foods directly?

No. The products all require a prescription. Please speak with your physician if you are interested in the dietary management of disease.