METHODS OF REDUCING VISCERAL FAT AND RELATED COMPOSITIONS

• US 20190053529A1
• Filed: 08/16/2017
• Published: 02/21/2019
• Est. Priority Date: 08/16/2017
• Status: Active Grant

• Current Assignee: 20Lighter, LLC
• Original Assignee: 20Lighter Corporate Health & Wellness, LLC
• Inventors: Barnes, Jessica, Dembrowski, Gerald
• Granted Patent: US 10,638,786 B2
• Time in Patent Office: Days
• CPC Class Codes: A23L 33/10 using additives addition of substantially indigestible substances A23L33/21
• CPC Class Codes: A23L 33/30 Dietetic or nutritional methods, e.g. for losing weight A23L33/10 takes precedence
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: G09B 19/00 Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26
• CPC Class Codes: G09B 19/0092 Nutrition

Abstract

Methods and compositions are provided directed to decreasing visceral fat in subjects. Visceral fat is directly linked to cardiovascular and metabolic disease risk. The methods describe a calorie restricted diet of specific percentages of food elements to be consumed within a specific time period each day. Calorie restriction and nutrient percentages take into consideration average daily normal activity of subjects as well as baseline health metrics including estimated amount of visceral fat. Remarkable results are obtained since visceral fat is targeted for reduction, thereby markedly reducing the risk of cardiovascular and metabolic disease. Unlike previous conventional weight loss programs, the methods are applicable to the general population including subjects of all ages, genders, and those with past histories of disease, comorbidities, prescription medications, weight fluctuations, and the like, and since the methods do not require surgery, hospitalization, liquid-only diets, prescription medication, or purchase of pre-package meal replacements and the like.

Claims

1. A method for decreasing visceral fat in a subject, which comprises:

determining a first amount of visceral fat in the subject;

administering to the subject a calorie-restricted diet of 500 to 850 calories per day;

determining a second amount of visceral fat in the subject;

wherein the diet is administered until visceral fat is decreased by 5% to 56% based on a difference between the first amount and the second amount of visceral fat,

wherein the subject is human of between 12 and 90 years of age, and

wherein the diet is administered for 20 to 60 days.

2. The method of claim 1, wherein the amount of visceral fat in the subject is determined by one or more of bioelectric impedance, body mass index, measurement of waist and/or hip circumference, hip to waist ratio, sagittal abdominal diameter, ultrasound, dual image/dual energy x-ray absorptiometry, air displacement plethysmography, and computed tomography.

3. The method of claim 1, wherein the subject is not pregnant, is not breastfeeding, is not currently receiving cancer therapy, is not currently receiving immunosuppressants following organ transplant, is not a practicing vegetarian, has not been diagnosed with bipolar disorder, schizophrenia, or advanced Alzheimer'"'"'s disease.

4. The method of claim 1, wherein the subject ingests food only within a prescribed constant daily time period of 10 hours, and wherein the subject ingests food only 4 to 6 hours after waking to 3 to 5 hours before sleep.

5. The method of claim 2, wherein the subject:

a) has low visceral fat and is sedentary and the calorie-restricted diet is between 650 and 725 calories per day;

b) has low visceral fat and is acutely active and the calorie-restricted diet is between 650 and 800 calories per day;

c) has low visceral fat and is chronically active and the calorie-restricted diet is between 750 and 850 calories per day;

d) has high visceral fat and is sedentary and the calorie-restricted diet is between 500 and 550 calories per day;

e) has high visceral fat and is acutely active and the calorie-restricted diet is between 500 and 650 calories per day;

f) has high visceral fat and is chronically active and the calorie-restricted diet is between 650 and 750 calories per day;

wherein the sedentary subject has an increased heart rate above resting level for less than 45 minutes per day,

wherein the acutely active subject has an increased heart rate above resting level for 45 minutes or more, one to two times per week,

wherein the chronically active subject has an increased heart rate above resting level for 45 minutes or more, three times or more per week.

6. The method of claim 5,

wherein when the subject is male and the amount of visceral fat in the subject is determined by hip to waist ratio, then low visceral fat is a score of less than 0.85, and high visceral fat is a score greater than or equal to 0.85,

wherein when the subject is female and the amount of visceral fat in the subject is determined by hip to waist ratio, then low visceral fat is a score of less than 0.90, and high visceral fat is a score greater than or equal to 0.90,

wherein when the subject is male and the amount of visceral fat in the subject is determined by waist circumference, then low visceral fat is a score of less than 90 cm, and high visceral fat is a score greater than or equal to 90 cm,

wherein when the subject is female and the amount of visceral fat in the subject is determined by waist circumference, then low visceral fat is a score of less than 80 cm, and high visceral fat is a score greater than or equal to 80 cm,

wherein when the amount of visceral fat in the subject is determined by sagittal abdominal diameter, then low visceral fat is a score of less than 25 cm, and high visceral fat is a score greater than or equal to 25 cm,

wherein when the amount of visceral fat in the subject is determined by ultrasound, then low visceral fat as measured by intra-abdominal thickness is a score of less than 7 cm, and high visceral fat as measured by intra-abdominal thickness is a score greater than or equal to 7 cm,

wherein when the subject is male and the amount of visceral fat in the subject is determined by magnetic resonance imaging (MRI), computerized tomography (CT), or dual-energy x-ray absorptiometry (DEXA), then low visceral fat is a score of less than 90 cm², and high visceral fat is a score greater than or equal to 90 cm²,

wherein when the subject is female and the amount of visceral fat in the subject is determined by MRI, CT, or DEXA, then low visceral fat is a score of less than 70 cm², and high visceral fat is a score greater than or equal to 70 cm², and/or

wherein the amount of visceral fat in the subject is determined by a class 2 bioelectric impedance instrument, and wherein high visceral fat and low visceral fat is indicated by the bioelectric impedance instrument.

7. The method of claim 1, wherein:

the subject is between 40 and 65 years old,

the diet is administered for 20 days and the diet is administered until visceral fat is decreased by at least 5%, and/or

the diet is administered for 60 days and the diet is administered until visceral fat is decreased by at least about 17% to about 30%.

8. The method of claim 1, wherein the subject experiences a mean reduction in visceral fat of between 5% to about 30%.

9. The method of claim 1, wherein the calorie-restricted diet consists of:

(a) no more than 1 gallon of non-caffeinated beverages per day, (b) two to three daily portions each of meat, vegetables, and fruit, and optionally (c) flavorants,

wherein the flavorants are selected from the group consisting of;

spices, stevia, erythritol, monkfruit extract, pink Himalayan sea salt, and any combination thereof,

wherein the portion of meat is about 3 ounces, the portion of vegetables is about 1 cup, and the portion of fruit is about 1 cup,

wherein the non-caffeinated beverages are selected from the group consisting of;

unsweetened iced tea, club soda, coffee, seltzer water, and water, and

wherein the water optionally consists of one or more of stevia, lemon juice, lime juice, vitamin C, citric acid, monkfruit extract, erythritol, and xylitol.

10. The method of claim 9, wherein the meat is fresh or flash frozen, optionally from organically grown and/or free-range raised animals, is less than 7% fat, and is selected from the group consisting of:

chicken, turkey, fish, shellfish, beef, egg whites, and any combination thereof.

11. The method of claim 10, wherein beef is obtained only from cow, bison, elk, deer, or any combination thereof, and wherein beef consists of beef tenderloin, beef sirloin, beef London broil, beef fillet, or any combination thereof.

12. The method of claim 10, wherein fish and shellfish are selected from the group consisting of:

cod, flounder, haddock, halibut, tilapia, sea bass, red snapper, wahoo, grouper, marlin, pollock, trout, sole, red fish, tuna, squid, octopus, mussels, lobster, shrimp, crab, scallops, oysters, clams, mussels, and any combination thereof.

13. The method of claim 10, wherein the chicken and the turkey do not comprise skin, fat, and deli cuts, and wherein no calories are added to the chicken and the turkey other than the flavorants.

14. The method of claim 9, wherein the vegetables and the fruit are organically grown, are fresh or flash frozen, and are not dried, not canned, and not preserved.

15. The method of claim 9, wherein the vegetables are selected from the group consisting of:

artichokes, asparagus, bamboo shoots, bean sprouts, broccoli, Brussels sprouts, cabbage, cauliflower, celery, cucumber, fennel, leafy greens, garlic, green beans, green peas, leeks, mushrooms, okra, onion, radishes, shallots, tomatoes, peppers, bell peppers, hot peppers, zucchini, and any combination thereof, and

wherein the leafy greens are selected from the group consisting of;

arugula, spinach, kale, cabbage, bok choy, swiss chard, collard greens, dandelion greens, lettuce, and any combination thereof.

16. The method of claim 9, wherein the fruit is selected from the group consisting of:

citrus fruit, berries, cherries, apples, apricots, peaches, pears, plum, nectarines, and any combination thereof.

17. The method of claim 16, wherein the citrus fruit is selected from the group consisting of:

lemon, lime, grapefruit, tangerine, mandarin oranges, ugly fruit, clementine, tangelo, and any combination thereof, and wherein the berries consist of raspberries, blackberries, blueberries, strawberries, and any combination thereof.

18. The method of claim 9, wherein about 45% to about 60% of caloric intake is derived from meat, about 15% to about 25% of daily caloric intake is derived from vegetables, and about 20% to about 30% of daily caloric intake is derived from fruit.

19. The method of claim 9, wherein:

no oil is added to the food,

no salt is added to the food except optionally Himalayan pink salt,

no synthetic or natural sugars or artificial sweeteners are added to the food, and

wherein no monosodium glutamate (MSG) is added to the food.

20. The method of claim 9, wherein the spices are dried and crushed plant material selected from the group consisting of:

nutmeg, allspice, pepper, chive, oregano, cilantro, cinnamon, basil, bay leaves, cloves, coriander, cumin, fennel, garlic, ginger, juniper, mace, marjoram, mint, onion, paprika, parsley, rosemary, saffron, caraway seed, celery seed, parsley, tarragon, thyme, mustard seed, anise seed, poppy seed, lemongrass, star anise, turmeric, peppercorn, savory, achiote seed, epazote, sage, vanilla bean, and any combination thereof.

21. The method of claim 6, wherein the class 2 bioelectric impedance instrument manufactured by Tanita®

, Omron®

, InBody®

, Seca®

, or Boditrax®

, and

wherein the amount of visceral fat in the subject is determined by the Tanita®

class 2 bioelectric impedance instrument, and wherein low visceral fat is a score of less than 11, and high visceral fat is a score greater than or equal to 11,

wherein the amount of visceral fat in the subject is determined by the Omron®

class 2 bioelectric impedance instrument, and wherein low visceral fat is a score of less than 10, and high visceral fat is a score greater than or equal to 10,

wherein the amount of visceral fat in the subject is determined by the InBody®

class 2 bioelectric impedance instrument, and wherein low visceral fat is a score of less than 11 or 70 cm², and high visceral fat is a score greater than or equal to 11 or 70 cm²,

wherein the amount of visceral fat in the subject is determined by the Seca®

class 2 bioelectric impedance instrument, and wherein low visceral fat is a score of less than 2.0, and high visceral fat is a score greater than or equal to 2.0, and/or

wherein the amount of visceral fat in the subject is determined by the Boditrax®

class 2 bioelectric impedance instrument, and wherein low visceral fat is a score of less than 11, and high visceral fat is a score greater than or equal to 11.

22. The method of claim 1, wherein the subject never on any day consumes less than 500 calories, and wherein on average the subject never consumes less than 500 calories per day.

23. The method of claim 1, wherein visceral fat comprises:

fat surrounding the subject'"'"'s thoracic and abdominal organs and major vessels, intra-abdominal adipose tissue, and/or organ fat, and wherein visceral fat is not subcutaneous fat, and/or

mesenteric fat, omental fat, periaortic fat, epicardial fat, intramuscular fat, neck adipose tissue, gonadal fat, gluteal femoral fat, and perirenal fat.

24. The method of claim 23, wherein the thoracic and abdominal organs comprise stomach, liver, pancreas, kidneys, heart, lungs, and intestines, and

wherein the major vessels comprise the aorta, brachial arteries, carotid arteries, subclavian arteries, pulmonary arteries, celiac trunk artery, superior and inferior mesenteric arteries, suprarenal arteries, renal arteries, and gonadal arteries, pulmonary veins, superior vena cava, inferior vena cava, brachiocephalic veins, and hepatic portal vein.

25. The method of claim 1, wherein the subject has had, or was previously diagnosed with, or has a history of, or presents with symptoms of, type 2 diabetes, hypertension, dyslipidemia or triglyceridemia, hypocholesterolemia, cardiovascular conditions and diseases, depression, weight loss or gain six months prior to performing the method, surgery (including weight loss surgery), hypothyroidism, and/or abnormal glucose tolerance (pre-diabetes).

26. The method of claim 1, wherein the subject has taken or has been prescribed contraceptives, lipid and/or triglyceride lowering agents, agents for treating hypertension, antidepressants, thyroid hormone replacement agents, active agents for treating type 2 diabetes, and/or gout medications.

27. The method of claim 1, wherein the calorie-restricted diet comprises both liquid and solid food, does not comprise pre-packaged food or processed food, does not require hospitalization, and/or does not require that the subject undergo surgery either before or after the method.

28. A method for decreasing visceral fat in a subject, which comprises:

determining a first amount of visceral fat in the subject;

administering to the subject a calorie-restricted diet of 500 to 850 calories per day;

determining a second amount of visceral fat in the subject;

wherein the diet is administered until visceral fat is decreased by 5% to 56% based on a difference between the first amount and the second amount of visceral fat,

wherein the subject is human of between 12 and 90 years of age,

wherein the diet is administered for 19 to 60 days,

wherein the daily calorie-restricted diet consists of no more than 1 gallon of non-caffeinated beverages, two to three portions each of meat, vegetables, and fruit, and flavorants,

wherein the flavorants consist of spices, stevia, erythritol, monkfruit extract, pink Himalayan sea salt, and any combination thereof,

wherein the portion of meat is about 3 ounces, the portion of vegetables is about 1 cup, and the portion of fruit is about 1 cup,

wherein the meat is fresh or flash frozen, less than 7% fat, and is selected from the group consisting of chicken, turkey, fish, shellfish, beef, egg whites, and any combination thereof,

wherein no oil, no salt except pink Himalayan salt, no monosodium glutamate (MSG), no synthetic and natural sugars, and no artificial sweeteners are added to the food, and

wherein the subject never on any day consumes less than 500 calories, and wherein on average the subject never consumes less than 500 calories per day.