Therapeutic process for the treatment of obesity and associated metabolic disorders

Abstract

The present invention is directed to a method of treating a patient suffering from the metabolic syndrome and/or related disorders including Type 2 diabetes, comprising the steps of (a) providing to the patient a dietary regimen that decreases overactive sympathetic tone; followed by (b) providing to the patient a dietary regimen that increases dopaminergic tone while maintaining the above decreased overactive sympathetic tone. The present invention is also directed to prepackaged meals and recipes useful in implementing the dietary regimens.

What is claimed is:  
     
         1 . A method of treating a patient suffering from the metabolic syndrome and/or related disorders, comprising the steps of: 
 (a) providing to said patient a dietary regimen that decreases overactive sympathetic tone; followed by    (b) providing to said patient a dietary regimen that increases dopaminergic tone while maintaining said decreased overactive sympathetic tone.    
     
     
         2 . The method of  claim 1 , wherein said dietary regimen that decreases overactive sympathetic tone comprises: 
 1) protein intake of about 25%±5% of total daily caloric intake;    2) monounsaturated fat intake of about 25%±5% of total daily caloric intake;    3) saturated fat intake of about 5%±5% of total daily caloric intake;    4) polyunsaturated fat intake of about 3%±5% of total daily caloric intake;    5) complex carbohydrate intake of about 42%±7% of total daily caloric intake; and    6) total caloric intake set at 15-25% less than the said patient's daily energy expenditure.    
     
     
         3 . The method of  claim 1 , wherein said dietary regimen that decreases overactive sympathetic tone comprises: 
 1) protein intake of about 25%±3% of total daily caloric intake;    2) monounsaturated fat intake of about 25%±3% of total daily caloric intake;    3) saturated fat intake of about 5%±3% of total daily caloric intake;    4) polyunsaturated fat intake of about 3%±3% of total daily caloric intake;    5) complex carbohydrate intake of about 42%±5% of total daily caloric intake; and    6) total caloric intake set at 15-20% less than the patient's daily energy expenditure.    
     
     
         4 . The method of  claim 1 , wherein said dietary regimen that increases dopaminergic tone while maintaining said decreased overactive sympathetic tone comprises: 
 1) protein intake of about 24%±5% of total daily caloric intake;    2) monounsaturated fat intake of about 23%±5% of total daily caloric intake;    3) saturated fat intake of about 5%±5% of total daily caloric intake;    4) polyunsaturated fat intake of about 3%±5% of total daily caloric intake;    5) complex carbohydrate intake of about 45%±7% of total daily caloric intake;    6) total caloric intake set at 15-25% less than said patient's daily energy expenditure; and    7) L-DOPA-containing foods in an amount sufficient to ingest about 20-400 mg. of L-DOPA per day.    
     
     
         5 . The method of  claim 1 , wherein said dietary regimen that increases dopaminergic tone while maintaining said decreased overactive sympathetic tone comprises: 
 1) protein intake of about 24%±3% of total daily caloric intake;    2) monounsaturated fat intake of about 23%±3% of total daily caloric intake;    3) saturated fat intake of about 5%±3% of total daily caloric intake;    4) polyunsaturated fat intake of about 3%±3% of total daily caloric intake;    5) complex carbohydrate intake of about 45%±5% of total daily caloric intake;    6) total caloric intake set at 15-20% less than said patient's daily energy expenditure; and    7) L-DOPA-containing foods in an amount sufficient to ingest about 20-300 mg. of L-DOPA per day.    
     
     
         6 . The method of  claim 5 , wherein said L-DOPA-containing foods are present in an amount sufficient to ingest about 20-150 mg. of L-DOPA per day.  
     
     
         7 . The method of  claim 1 , wherein in each of said dietary regimen steps (a) and (b), simple sugars and/or high glycemic index carbohydrates are not provided concurrently with fats at a weight ratio greater than 1 carbohydrate to 4 saturated fat.  
     
     
         8 . The method of  claim 1 , further comprising the step of establishing a baseline of metabolic activity in said patient by measuring the amounts of neuroendocrine compounds in said patient's blood prior to said providing steps.  
     
     
         9 . The method of  claim 8 , wherein said neuroendocrine compounds are selected from the group consisting of plasma norepinephrine, norepinephrine metabolite, insulin, dopamine, doparnine metabolite, cortisol, morning urination melatonin metabolite, plasma norepinephrine, norepinephrine metabolite, plasma serotonin, plasma serotonin metabolite, and combinations thereof.  
     
     
         10 . The method of  claim 8 , wherein said providing step (b) is implemented when plasma norepinephrine, norepinephrine metabolite, and/or insulin levels are reduced by approximately 20% relative to the levels established in said establishing step.  
     
     
         11 . The method of  claim 8 , wherein said providing step (b) step is implemented when morning urinary norepinephrine metabolite levels are reduced by approximately 20% relative to the levels established in said establishing step.  
     
     
         12 . The method of  claim 8 , wherein said providing step (b) step is implemented when glucose tolerance norepinephrine levels are reduced by approximately 20% relative to the levels established in said establishing step.  
     
     
         13 . The method of  claim 8 , wherein said providing step (b) step is implemented when plasma norepinephrine to dopamine neurotransmitter or neurotransmitter metabolite ratio are reduced by approximately 20% relative to the levels established in said establishing step.  
     
     
         14 . The method of  claim 1 , wherein said providing step (a) continues for approximately 4 to 12 weeks.  
     
     
         15 . The method of  claim 1 , wherein said providing step (b) continues for approximately 4 to 6 months.  
     
     
         16 . The method of  claim 1 , further comprising the step of administering between 50 and 2000 mg of a serotonin precursor to said patient before bedtime.  
     
     
         17 . The method of  claim 16 , wherein said serotonin precursor is selected from the group consisting of L-tryptophan, L-5-hydroxytryptophan, and combinations thereof.  
     
     
         18 . An article of manufacture comprising packaging material and one or more food products contained within said packaging material, wherein said one or more food products are effective for decreasing overactive sympathetic tone and wherein said packaging material comprises a label which indicates that said one or more food products can be used for treating the metabolic syndrome and/or related disorders in a patient, and wherein said one or more food products are selected from the group consisting of: 
 1) protein of about 25%±5% of total daily caloric intake of said patient;    2) monounsaturated fat of about 25%±5% of total daily caloric intake of said patient;    3) saturated fat of about 5%±5% of total daily caloric intake of said patient;    4) polyunsaturated fat of about 3%±5% of total daily caloric intake of said patient; and    5) complex carbohydrate of about 42%±7% of total daily caloric intake of said patient; 
 and combinations thereof.  
   
     
     
         19 . The article of manufacture of  claim 18 , wherein the total caloric value of said one or more food products, in combination with regular food, is approximately 15-25% less than the said patient's daily energy expenditure.  
     
     
         20 . The article of manufacture of  claim 19 , wherein said total caloric value of said one or more food products, in combination withr regular food, is approximately 15-20% less than the said patient's daily energy expenditure  
     
     
         21 . The article of manufacture of  claim 18 , wherein said label comprises instructions on how to consume said one or more food products.  
     
     
         22 . An article of manufacture comprising packaging material and one or more food products contained within said packaging material, wherein said one or more food products are effective for increasing dopaminergic tone while maintaining decreased overactive sympathetic tone, and wherein said packaging material comprises a label which indicates that said one or more food products can be used for treating the metabolic syndrome and/or related disorders in a patient, and wherein said one or more food products are selected from the group consisting of: 
 1) protein of about 24%±5% of total daily caloric intake of said patient;    2) monounsaturated fat of about 23%±5% of total daily caloric intake of said patient;    3) saturated fat of about 5%±5% of total daily caloric intake of said patient;    4) polyunsaturated fat of about 3%±5% of total daily caloric intake of said patient;    5) complex carbohydrate of about 45%±5% of total daily caloric intake of said patient;    6) L-DOPA-containing food in an amount sufficient to ingest about 25-400 mg. of L-DOPA per day; 
 and combinations thereof.  
   
     
     
         23 . The article of manufacture of  claim 22 , wherein said L-DOPA-containing food is present in an amount sufficient to ingest 30-300 mg of L-DOPA per day.  
     
     
         24 . The article of manufacture of  claim 22 , wherein said L-DOPA-containing food is present in an amount sufficient to ingest 40-150 mg of L-DOPA per day.  
     
     
         25 . The article of manufacture of  claim 22 , wherein said protein rich, L-DOPA-containing food comprises 40-100 grams of Broad Beans (Vicia faba) or fava beans.  
     
     
         26 . The article of manufacture of  claim 22 , wherein the total caloric value of said food products, in combination with regular food, is approximately 15-25% less than the said patient's daily energy expenditure.  
     
     
         27 . The article of manufacture of  claim 22 , wherein said total caloric value of said one or more food products, in combination with regular food, is approximately 15-20% less than the said patient's daily energy expenditure  
     
     
         28 . The article of manufacture of  claim 22 , wherein said label comprises instructions on how to consume said one or more food products.