MEDICAL FOODS FAQ

What is a medical food?  

The Orphan Drug Act of 1988 defines a medical food as “a food which is formulated to be consumed or administered enterally (or orally) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical foods are specially formulated and intended for the dietary management of patients with medical conditions with distinctive nutritional requirements, which cannot be managed solely by altering a normal diet. Medical foods must be used under the supervision of a licensed health care practitioner.

How are medical foods different from other foods, dietary supplements, and drugs?  

Medical foods differ from traditional foods in that medical foods are formulations, not “whole” foods.  The ingredients in medical foods are classified by the FDA as generally recognized as safe (GRAS), dietary ingredients, or food additives. A medical food is specially formulated to meet distinctive nutritional requirements for the specific dietary management of a patient.  

Medical foods are also different from dietary supplements. Medical foods are intended for patient nutrition, while dietary supplements are intended for healthy individuals ages 18 and up. Medical foods may include specific claims for a patient suffering from a medical condition, while dietary supplements may only include general health and wellness claims. Therefore, the labeling and use of the products are significantly different. Traditional foods, dietary supplements and medical foods may all contain similar ingredients, but the product formula, labeling, and intended use are very different.  

Medical foods are not drugs. Medical foods are intended to improve the nutrition of a patient with distinct nutritional requirements. Drugs are the only products that can be labeled as a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Why do I need my doctor to complete a form before I can order trumacro™ ketogenic medical foods? 

Medical foods are intended to be consumed or administered enterally (or orally) under the supervision of a physician or other licensed health care practitioner (HCP). Your HCP will decide how much of the medical food you should take each day and how often. Without the HCP’s involvement, a patient may inadvertently take too much or too little of the formula. Improved nutrition can have many positive benefits on a patient’s response to their underlying illness, disease, or disorder. The HCP will take into consideration:

  • Age
  • Body weight
  • Activity level
  • Diet
  • Diagnosis and medical conditions (genetics, metabolic disorders, seizures, etc.)
  • Medications
  • Other health concerns

Who should use trumacro™ ketogenic medical foods? Are they used for weight loss, diabetes, cancer, or other conditions?  

trumacro™ Ketogenic BHB is a medical food for the dietary management of a patient requiring a source of ketone bodies, such as certain inborn errors of metabolism and genetic disorders (fatty acid oxidation disorders; glycogen storage disease type III; 3-hydroxy-3-methylglutaryl-coenzyme A lyase deficiency; congenital hyperinsulinism). trumacro™ Ketogenic BHB + MCT is a medical food for the dietary management of a patient requiring a source of ketone bodies where medium-chain triglycerides are tolerated, and other medical conditions for which the ketogenic diet is indicated.  trumacro™ ketogenic medical foods are not intended to be used as a sole source of nutrition and must be used under the supervision of a licensed health care practitioner. trumacro™ Ketogenic BHB + MCT is currently in clinical trials as a nutritional intervention for pediatric patients with Angelman syndrome (NCT03644693) and drug-resistant epilepsy (IRB#2020-3267).

Will trumacro™ ketogenic medical foods work for me or my child? 

trumacro™ ketogenic medical foods are intended to be used under medical supervision. Your doctor will evaluate your condition and the available clinical evidence in order to decide whether beta-hydroxybutyrate-containing medical foods should be part of your nutrition plan. There is emerging evidence that patients with certain metabolic disorders, genetic conditions, and drug-resistant seizures may benefit from nutritional ketosis and fuel from beta-hydroxybutyrate. Not all patients will benefit from improved nutrition using beta-hydroxybutyrate.

What will trumacro™ ketogenic medical foods do for my nutrition? 

trumacro™ ketogenic medical foods contain beta-hydroxybutyrate. Upon ingestion, blood ketone levels will rise, and the patient will be in “ketosis.” Consuming beta-hydroxybutyrate-containing medical foods can be an adjunct to the ketogenic diet in order to boost ketone levels quickly. Ketones provide an alternate source of fuel for the body, which can be critical for good nutrition for patients with certain metabolic disorders, genetic conditions, and seizures. Your physician will determine what outcomes are most likely from this shift in nutrition. The goal of improved nutrition is to better equip the patient to respond to their disease which can lead to better outcomes.

How long after consuming trumacro™ ketogenic medical foods will I see or feel an effect? 

Within 60-90 minutes of consuming trumacro™ ketogenic medical foods, blood ketone levels will increase, and soon thereafter, urine ketone levels will also go up. The level of ketones circulating in the body will depend on many factors including the patient’s underlying medical conditions, basal diet, amount and type of formula consumed, fasted or fed state, activity level, concurrent medications, etc. Other long-term effects of improving nutrition through ketosis will vary depending on these same factors, so it is important to work with your medical team to evaluate the effectiveness of this type of dietary approach. In patients with drug-resistant seizures, families are encouraged to give the ketogenic diet a try for at least three months in order to determine whether there will be any benefits.

Which trumacro™ ketogenic medical food product should I use? What’s the difference?  

trumacro™ ketogenic medical foods are intended to be used under medical supervision. Your doctor will evaluate your condition and the available clinical evidence in order to decide which beta-hydroxybutyrate-containing medical food should be part of your nutrition plan. We offer products that solely contain beta-hydroxybutyrate and others that are a combination of beta-hydroxybutyrate and medium-chain triglycerides (MCT). Not all patients can tolerate fats or MCTs and your doctor will decide whether a combination is suitable or not. We offer unflavored and flavored formulas. trumacro™ Ketogenic BHB Unflavored is not suitable for eating or drinking by mouth. The unflavored formula is very bitter and unpalatable so it is recommended for tube feeding.

Can trumacro™ ketogenic medical foods be used in tube-fed patients? 

trumacro™ ketogenic medical foods can be used in tube-fed patients. Your medical team will work with you to determine the best dilution for tube feeding of the chosen formula.

What are the side effects of consuming trumacro™ ketogenic medical foods?  

There are no known incremental adverse reactions for the use of Ketogenic BHB + MCT as a part of dietary intervention. Consumption of MCT and D,L-Beta-Hydroxybutyrate mineral salts are well tolerated. Reported side effects include gastrointestinal discomfort, dehydration, metabolic alkalosis, and renal stone formation. Close medical supervision is required. The trumacro™ medical food formulations contain significant amounts of the electrolytes sodium, calcium, magnesium, and potassium and, therefore, should only be used under medical supervision. These formulations may not be suitable for individuals that are sodium sensitive. Not all patients that could benefit from nutritional ketosis are able to digest/metabolize fats, so trumacro™ Ketogenic BHB + MCT is only suitable for patients that can tolerate MCT. There are certain conditions in which a ketogenic diet may be contraindicated, and, therefore, the use of ketone-containing formulations may also be contraindicated such as: 

  • Beta-oxidation defects
  • Long-chain 3-hydroxyacyl-CoA deficiency 
  • Medium-chain 3-hydroxyacyl-CoA deficiency 
  • Carnitine deficiency (primary)
  • Carnitine palmitoyltransferase I or II deficiency
  • Carnitine translocase deficiency
  • Short-chain acyl dehydrogenase deficiency 
  • Medium-chain acyl dehydrogenase deficiency 
  • Long-chain acyl dehydrogenase deficiency 
  • Porphyria
  • Pyruvate carboxylase deficiency

Will trumacro™ ketogenic medical foods affect how my medications work?  

When used as a medical food for supplemental nutrition, ketogenic medical foods may impact how some drugs are metabolized. All medications should be discussed with a physician or pharmacist.  Medical supervision by a physician is required.

Does it matter what diet I am currently eating when using trumacro™ medical foods ? 

trumacro™ ketogenic medical foods may be used in conjunction with a variety of diets (standard, low glycemic, ketogenic). Your health care professional will take into account your medical conditions and dietary regimen when deciding whether ketogenic medical foods should be part of your nutrition.  

Should I get unflavored trumacro™ ketogenic medical foods? 

trumacro™ ketogenic medical foods are intended to be used under medical supervision. Your doctor will evaluate your condition and the available clinical evidence in order to decide which beta-hydroxybutyrate-containing medical foods should be part of your nutrition plan. We offer unflavored and flavored formulas of trumacro™ Ketogenic BHB. The unflavored formula is not suitable for eating or drinking by mouth because it is very bitter and, therefore, unpalatable. However, it is suitable for tube feeding.

Why is the nutrition label for trumacro™ ketogenic medical foods different from other foods and dietary supplements?  

Medical food labels are intended to convey nutrition information needed for a health care practitioner to determine how much of that formula should be incorporated into a patient’s diet. Medical food regulations for labels are different than those for other foods and dietary supplements; therefore, the labels are not provided in the same format.

What is a typical serving size for trumacro™ ketogenic medical foods?  

Your health care practitioner will determine the appropriate serving size for you. That is why there is no “serving size” listed on the product label. Your HCP will consider many details that are unique for each patient when calculating a serving, including:

  • Age
  • Body weight
  • Activity level
  • Diet
  • Diagnosis and medical conditions (genetics, metabolic disorders, seizures, etc.)
  • Medications
  • Other health concerns

Health care providers may find these calculators helpful in determining the serving size for a patient based on body weight and target BHB daily intake.

  • BHB+MCT Lemon Flavor Servings Calculator
  • BHB Orange Flavor Servings Calculator
  • BHB Unflavored Servings Calculator

How often should I take trumacro™ ketogenic medical foods?

Your health care practitioner will determine the frequency (how often) and duration (how long) you should consume the formulation. Your HCP will consider many details that are unique for each patient when calculating dosage duration and frequency, including:

  • Age
  • Body weight
  • Activity level
  • Diet
  • Diagnosis and medical conditions (genetics, metabolic disorders, seizures, etc.)
  • Medications
  • Other health concerns

Can a household measure be used instead of weighing the formula?  

If appropriate, your health care practitioner may suggest a household measurement conversion instead of weighing each serving. You should always consult with your HCP before changing the amount of formula you are consuming. Do not change from weighing your formula in grams to using a household measure without your HCP’s input. Some patients must weigh their formula. If household measures are appropriate, the following conversions can be used. All measures are “leveled” i.e. “one level teaspoon.”

Formula in grams Household Measure
0.35 1/8 teaspoon
0.7 1/4 teaspoon
1.4 1/2 teaspoon
2.8 1 teaspoon
5.6 2 teaspoons
9 1 tablespoon
35 1/4 cup
70 1/2 cup
140 1 cup

Why is there a scoop in the trumacro™ ketogenic medical foods container?  

The scoop included with each container of trumacro™ ketogenic medical foods should be used to weigh product using a gram scale if your health care practitioner has determined your serving based on grams of formula. THE SCOOP SHOULD NOT BE USED TO DELIVER A “SERVING SIZE” OF FORMULA.  Your health care practitioner will determine the appropriate serving size for you. That is why there is no “serving size” listed on the product label. Your HCP will consider many details that are unique for each patient when calculating a serving. If appropriate, your HCP may suggest a household measurement conversion instead of weighing each serving. You should always consult with your HCP before changing the amount of formula you are consuming. Do not change from weighing your formula in grams to using a household measure without your HCP’s input. Some patients must weigh their formula.

How many grams of carbs/fat/proteins are in each serving of trumacro™ ketogenic medical foods? 

Your health care practitioner will determine the appropriate serving size for you. That is why there is no “serving size” listed on the product label. Your HCP will consider many details that are unique for each patient when calculating a serving. The nutrition information on the label of trumacro™ ketogenic medical foods containers are based on 100 grams of formula. The formula is listed at the Charlie Foundation’s Keto Diet Calculator to calculate the macro- and micronutrients for a specific amount of ketogenic medical food formula. If appropriate, your HCP may suggest a household measurement conversion instead of weighing each serving.  

Why should I use a BHB-containing medical food? Can’t I just use a BHB-containing supplement from a local grocery or supplement store?  

Your health care practitioner will determine whether you should use a dietary supplement or a medical food. Medical foods are different from dietary supplements. Medical foods are intended for patient nutrition, while dietary supplements are intended for healthy individuals ages 18 and up. A medical food is specially formulated to meet distinctive nutritional requirements for the specific dietary management of a patient. Medical food labeling can include specific claims for a patient suffering from a medical condition, while dietary supplements may only include general health and wellness claims. Traditional foods, dietary supplements, and medical foods may all contain similar ingredients, but the product formula, labeling, and intended use are very different. All trumacro™ ketogenic medical foods are tested for purity and potency of every labeled macro- and micronutrient– every lot, every test, every time. A certificate of analysis is available upon request.

Why do trumacro™ ketogenic medical foods contain silicon dioxide?  

Silicon dioxide is a safe, widely used food ingredient that is included in small amounts in trumacro™ ketogenic medical foods in order to prevent clumping due to the humid conditions that can occur during home use.

Why do some trumacro™ ketogenic medical foods contain flavors?  

The primary ingredients in trumacro™ ketogenic medical foods, if left unflavored, are not suitable for eating or drinking by mouth because they are very bitter and unpalatable. The flavored formulas contain naturally sourced and derived non-nutritive sweeteners, bitter blockers, and flavors.  

Why do the flavored trumacro™ ketogenic medical foods contain sweeteners?  

Flavored versions of trumacro™ ketogenic medical foods contain the sugar alternative, stevia extract, and are recommended for oral feeding. The primary ingredients in trumacro™ ketogenic medical foods, if left unflavored, are not suitable for eating or drinking by mouth because they are very bitter and unpalatable. The flavored formulas contain naturally sourced and derived non-nutritive sweeteners, bitter blockers, and flavors. Many patients will have dietary restrictions which limit carbohydrate intake; thus, sugar is not used in the formulas.

Do the flavored trumacro™ ketogenic medical foods contain artificial sweeteners?

No artificial sweeteners or flavors are used in any trumacro medical foods. The flavored formulas contain naturally sourced and derived non-nutritive sweeteners (stevia extract), bitter blockers, and flavors.

Why does trumacro™ Ketogenic BHB+MCT contain dairy?  

trumacro™ Ketogenic BHB + MCT contains milk. Trace amounts of milk proteins are present in the formula from the non-fat dry milk in MCT powder.

Will the MCT in trumacro™ Ketogenic BHB+MCT cause gastrointestinal issues?  

MCT may cause stomach discomfort to those who are new to MCT. It is possible that patients may experience some stomach discomfort or diarrhea after consuming trumacro™ Ketogenic BHB+MCT. It will be important to talk with your HCP if you experience any side effects after consuming the formula. A typical strategy to avoid any GI upset is to start at a smaller serving size, then gradually increase the amount consumed at each serving as your body gets used to digesting MCT.

May I try a sample of trumacro™ ketogenic medical foods before purchasing?  

Currently, samples are not available for trumacro™ ketogenic medical foods. Please contact your local patient advocacy group for upcoming events where trumacro™ will be having taste tests of the formulations. Typically, your physician or HCP will want to evaluate your response to trumacro™ ketogenic medical foods for 1-3 months before deciding whether ongoing nutritional therapy is appropriate. Thus, a sample would only provide an idea of taste, but not the patient’s response.

May I try a trumacro™ product for free?  

Patients that are enrolled in our clinical trials will have trumacro™ ketogenic medical foods for free as part of their participation in a trial. Typically, your physician or HCP will want to evaluate your response to trumacro™ ketogenic medical foods for 1-3 months before deciding if ongoing nutritional therapy is appropriate. Thus, a sample would only give an idea of taste, but not the patient’s response.

What is your return policy for trumacro™ medical foods?

We want all of our customers to be satisfied with their experience. If the product is not meeting your expectations, please email your concerns to support@trumacro.com and our customer service team will walk you through the return process.

Are trumacro™ medical foods available outside the US?  

trumacro™ medical foods are not available outside the U.S. at this time.