Methods of reducing visceral fat and related compositions

• US 10,638,786 B2
• Filed: 08/16/2017
• Issued: 05/05/2020
• Est. Priority Date: 08/16/2017
• Status: Active Grant

• Current Assignee: 20Lighter, LLC
• Original Assignee: Zolighter LLC
• Inventors: Barnes, Jessica, Dembrowski, Gerald
• Primary Examiner(s): Hull, James B
• Application Number:
  US15/679,043
• Publication Number:
  US 20190053529A1
• Time in Patent Office: 993 Days
• Field of Search: None
• 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 of treating overweight or obesity in a subject by decreasing visceral fat in the subject, which comprises:

(a) determining a first estimated amount of visceral fat in the subject;

(b) administering to the subject a calorie-restricted diet of 500 to 850 calories per day, wherein the subject consumes the diet daily;

(c) determining a second estimated amount of visceral fat in the subject at least once per week beginning after the first estimated amount of visceral fat in the subject is determined; and

(d) repeating steps (b) and (c) until the second estimated amount of visceral fat is decreased in the subject by about 5% to about 56% with respect to the first estimated amount of visceral fat determined in the subject, and for at most 60 days counted from when the subject first consumes the calorie-restricted daily diet, thereby treating overweight or obesity in the subject by decreasing visceral fat in the subject,

wherein determining the first and second estimated amount of visceral fat in the subject comprises obtaining one or more of the following measurements from the subject;

(i) measuring a hip to waist ratio of the subject,

(ii) measuring a waist or hip circumference of the subject,

(iii) measuring a sagittal abdominal diameter of the subject,

(iv) measuring an intra-abdominal thickness of the subject by ultrasound,

(v) measuring visceral fat in the subject by magnetic resonance imaging (MRI), computerized tomography (CT), or dual-energy x-ray absorptiometry (DEXA),

(vi) measuring visceral fat in the subject by a class 2 bioelectric impedance instrument, and

(vii) measuring a body mass index (BMI) of the subject,

and

wherein determining the first and second and all subsequent estimated amounts of visceral fat comprises correlating the one or more measurements to the estimated amount of visceral fat in the subject, and

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

2. 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.

3. 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.

4. The method of claim 1, wherein:

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

b) if the subject has low visceral fat and is acutely active, then the administered calorie-restricted diet consumed by the subject is between 650 and 800 calories per day;

c) if the subject has low visceral fat and is chronically active, then the administered calorie-restricted diet consumed by the subject is between 750 and 850 calories per day;

d) if the subject has high visceral fat and is sedentary, then the administered calorie-restricted diet consumed by the subject is between 500 and 550 calories per day;

e) if the subject has high visceral fat and is acutely active, then the administered calorie-restricted diet consumed by the subject is between 500 and 650 calories per day;

or

f) if the subject has high visceral fat and is chronically active, then the administered calorie-restricted diet consumed by the subject 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, and

wherein;

if 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,

if 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,

if 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,

if 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,

if 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,

if 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,

if 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,

if 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

if the amount of visceral fat in the subject is determined by a class 2 bioelectric impedance instrument, then high visceral fat and low visceral fat is indicated by a score determined by the class 2 bioelectric impedance instrument corresponding to high visceral fat and low visceral fat, respectively.

5. The method of claim 1, wherein:

the subject is between 40 and 65 years old,

the diet is administered for at most 20 days from beginning step (b) or the diet is administered until visceral fat is decreased by at least about 17% to about 30% with respect to the first estimated amount of visceral fat in the subject, whichever occurs first.

6. The method of claim 1, wherein the subject is administered the diet until the subject experiences a mean reduction in visceral fat of between about 5% to about 30% with respect to the first estimated amount of visceral fat in the subject.

7. 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.

8. The method of claim 7, 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 obtained from the group consisting of:

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

9. The method of claim 8, wherein the meat is obtained only from cow, bison, elk, deer, or any combination thereof, and wherein the meat is less than 5% fat.

10. The method of claim 8, wherein the meat is obtained from at least fish and shellfish, and wherein the fish and the 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.

11. The method of claim 8, wherein the meat is obtained from at least chicken and/or at least turkey, and 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.

12. The method of claim 7, wherein the vegetables and the fruit are organically grown, are fresh or flash frozen, and are not dried, not canned, and not preserved.

13. The method of claim 7, 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.

14. The method of claim 7, wherein the fruit is selected from the group consisting of:

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

15. The method of claim 14, 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.

16. The method of claim 7, 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.

17. The method of claim 7, wherein in step (b), the diet comprises:

no added oil other than oil naturally existing in the diet,

no added salt other than salt naturally existing in the diet except optionally Himalayan pink salt is added,

no synthetic or natural sugars or artificial sweeteners other than natural sugars naturally existing in the diet, and

no monosodium glutamate (MSG).

18. The method of claim 7, wherein the diet includes (c) flavorants and, wherein the flavorants are spices, and 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.

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

20. The method of claim 19, 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.

21. 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, hypothyroidism, and/or pre-diabetes abnormal glucose tolerance.

22. 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, anti-depressants, thyroid hormone replacement agents, active agents for treating type 2 diabetes, and/or gout medications.

23. The method of claim 1, wherein the calorie-restricted diet further comprises both liquid and solid food, does not comprise pre-packaged food or processed food, wherein at all times the method is conducted outside of a hospital, and/or wherein the method is conducted without surgery performed on the subject.

24. A method of treating nonalcoholic fatty liver disease, hypertension, coronary artery disease, cardiovascular disease, and/or type 2 diabetes in a subject in need thereof by decreasing visceral fat in the subject, which comprises:

(a) determining a first estimated amount of visceral fat in the subject;

(b) administering to the subject a calorie-restricted diet of 500 to 850 calories per, wherein the subject consumes the diet daily;

(c) determining a second estimated amount of visceral fat in the subject at least once per week beginning after the first estimated amount of visceral fat in the subject is determined; and

(d) repeating steps (b) and (c) until the second estimated amount of visceral fat is decreased in the subject by about 5% to about 56% with respect to the first estimated amount of visceral fat in the subject, or for at most 60 days counted from when the subject first consumes the calorie-restricted daily diet, thereby treating overweight or obesity in the subject by decreasing visceral fat in the subject,

wherein determining the first and second estimated amount of visceral fat in the subject comprises obtaining one or more of the following measurements from the subject;

(i) measuring a hip to waist ratio of the subject,

(ii) measuring a waist or hip circumference of the subject,

(iii) measuring a sagittal abdominal diameter of the subject,

(iv) measuring an intra-abdominal thickness of the subject by ultrasound,

(v) measuring visceral fat in the subject by magnetic resonance imaging (MRI), computerized tomography (CT), or dual-energy x-ray absorptiometry (DEXA),

(vi) measuring visceral fat in the subject by a class 2 bioelectric impedance instrument, and

(vii) measuring a body mass index (BMI) of the subject, and

wherein determining the first and second and all subsequent estimated amounts of visceral fat comprises correlating the one or more measurements to the estimated amount of visceral fat in the subject.