Summary of the invention
In order to improve the slimming result for the treatment of of very low calorie diet, reduce simultaneously in strict diet control process, very easily occur weak, the incidence of the uncomfortable reaction such as aversion to cold and lassitude, according to domestic and international latest Progress, the characteristics such as carnitine shortage easily appear under the diet structure in conjunction with compatriots' prepared food and higher proportions of carbohydrate simultaneously, we research and develop the preparation method of the combustion fat that contains l-cn full nutrition low in calories for the meal preparation, research is found, in the diet control process, weak, the uncomfortable reaction such as aversion to cold and lassitude significantly reduces, Body weight loss is obvious simultaneously, without obvious thin soma, lose.
L-cn, be called again levocarnitine, DL-carnitine chloride, and its chemical name is β hydroxyl-γ-trimethyl ammonium butyrate, and its structural formula is that molecular formula is C7H15NO3, and molecular weight is 161.20, and modern study finds that its concrete physiological action is as follows:
As carrier with the fatty acyl carnitine form, LCFA is transported to from mitochondrial membrane to mitochondrial inner membrane and carries out beta oxidation, produce acetyl coenzyme A, enter tricarboxylic acid cycle, produce power.
2. the toxic products of fatty acid oxidation is eliminated to (long-chain fat coacetylase) in mitochondria; regulate free coacetylase and acidylate coacetylase; can effectively promote the oxidation of acetoacetate; contribute to intracellular metabolism; reduce ketoplasia; simultaneously can effectively alleviate fatty acid metabolism intermediate product (long-chain acyl, ceramide) to the inhibitory action of Mitochondria, alleviate keep on a diet due to metabolic rate descend.
3. participate in the oxidation of aliphatic acid at peroxidating corpusculum (Peroxisomal), when taking blood lipid-lowering medicine, this effect becomes and is even more important, because aliphatic acid increases by 10 to 20 times in the oxidation meeting of Peroxisomal in this case.
4. participate in the transportation of branched-chain amino acid as metabolites such as leucine, isoleucines, thereby be conducive to these amino acid whose eubolisms.
According to domestic and international current research, find, the high protein low caloric diet has following benefit for body weight control: 1. hyperaminoacidemia stimulates glucagon secretion, promotes fat splitting.
2. protein obviously delays gastric emptying, produces strong satiety, alleviates hunger.
3. high protein diet, reduce thin body protein and lose, and improves thin soma ratio.
In sum, from l-cn physiological action and modern study progress, in conjunction with strictly keeping on a diet down, weak, the aversion to cold be prone in body metabolism aliphatic acid process and the under-supply performance of lassitude homenergic, studies have shown that in the high protein very low calorie diet and add l-cn, and a kind of combustion fat full nutrition low in calories of developing is for the meal preparation, can effectively reduce weak, aversion to cold and the uncomfortable reaction such as dizzy, simultaneously, more be conducive to body weight control, the bounce-back of prevention body weight.
The present invention is prepared from by the bulk drug of calculating by mass percentage following weight parts:
Maltodextrin 20~30%, rice meal 5~15%, buckwheat 5~15%, soyabean protein powder 15~30%, PURE WHEY 10%~20%, sunflower oil 5~10%, mineral mixture 1.5~2.0%, vitamin mixtures 0.2~0.5%, l-cn 1-6%.
The weight portion proportion optimization of above-mentioned raw materials medicine:
Maltodextrin 30%, rice meal 5%, buckwheat 15%, soyabean protein powder 25%, PURE WHEY 15%, sunflower oil 6%, mineral mixture 1.5%, vitamin mixtures 0.5%, l-cn 2%.
The weight portion proportioning of above-mentioned raw materials medicine is also preferred:
Maltodextrin 24%, rice meal 13%, buckwheat 10%, soyabean protein powder 24%, PURE WHEY 16%, sunflower oil 5%, mineral mixture 1.8%, vitamin mixtures 0.2%, l-cn 1%.
The weight portion proportioning of above-mentioned raw materials medicine is also preferred:
Maltodextrin 26%, rice meal 7%, buckwheat 12%, soyabean protein powder 18%, PURE WHEY 20%, sunflower oil 10%, mineral mixture 1.6%, vitamin mixtures 0.4%, l-cn 5%.
The weight portion proportioning of above-mentioned raw materials medicine is also preferred:
Maltodextrin 23%, rice meal 14%, buckwheat 8%, soyabean protein powder 30%, PURE WHEY 13%, sunflower oil 8.8%, mineral mixture 2.0%, vitamin mixtures 0.2%, l-cn 4%.
The weight portion proportioning of above-mentioned raw materials medicine is also preferred:
Maltodextrin 25%, rice meal 11%, buckwheat 14%, soyabean protein powder 15%, PURE WHEY 18%, sunflower oil 9.5%, mineral mixture 1.2%, vitamin mixtures 0.3%, l-cn 6%.
The weight portion proportioning of above-mentioned raw materials medicine is also preferred:
Maltodextrin 28%, rice meal 15%, buckwheat 7%, soyabean protein powder 27%, PURE WHEY 10%, sunflower oil 8%, mineral mixture 1.5%, vitamin mixtures 0.5%, l-cn 3%.
The specific embodiment
Below in conjunction with accompanying drawing, this novel invention is further illustrated.
As shown in the figure, pulvis preparation method of the present invention is maltodextrin, mineral mixture, vitamin mixtures, and two dimension mixes in advance for the first time; Add and use l-cn, row two dimension for the second time mixes in advance; Then add rice meal, buckwheat, soyabean protein powder, PURE WHEY, the capable efficient three-dimensional hybrid of sunflower oil.Sieve, packing, obtain pulvis of the present invention.
Experimental example: the clinical trial data of the medical food of the present invention
For the curative effect of fat full nutrition low in calories for the meal preparation fired in checking the present invention, we take random, single blind, the parallel control method by 1:1, complete the medical food associating of the present invention EA and use patient's 120 examples, combustion fat generation low in calories meal (l-cn group) 60 examples, conventional generation meal group low in calories (control group) 60 examples.L-cn group adverse reaction rate approximately 12%, and control group adverse reaction rate approximately 27%, Epidemiological Analysis by statistics, between two groups, clinical efficacy has significant difference, uncomfortable significant reaction occurs lower than control group in the l-cn group, and l-cn group bad reaction generation symptom is slight, end test without 1 example, control group occurs that the aobvious weak person of the 4 routine systems of Himdu logic ends test.
(1) inclusive criteria: 1, age 18-70 year; 2, body mass index>=28kg/m
2; 3, signature Informed Consent Form.
(2) exclusion standard: gestation, lactation or menstrual period women; The heart, liver, renal function are undesired; Malignant tumour and inpatient with haematological diseases; The active tuberculosis patient; The ulcer patient of serious gastrorrhagia; Diabetes; Take impact sugar, fat metabolic drug person; Can not partner treatment, the poor person of compliance; Do not sign Informed Consent Form.
(3) research approach
Research approach is followed the Ethical Demand of Declaration of Helsinki in 1975, and obtaining No.1 Hospital Affiliated to Zhongshan Univ.'s ethics can ratify.This programme enters altogether group 120 examples and suffers from the experimenter, and all experimenters all sign Informed Consent Form; Random according to 1:1, single blind, contrast principle is divided into l-cn group and control group, all experimenters take in heat about 600kcal/d altogether every day, comprise that the full nutrition low in calories of combustion fat is for meal preparation (200Kcal/ bag, 1 bag/time, every day three times) (carbohydrate: protein: fat=50:43:6) and vegetable juice low in calories, totally 6 weeks time.Keep during this time the daily exercise amount, do not carry out strong physical sport, can be taken a walk, climb the mountain, swim and wait by bike motion, taboo basketball, football, hurry up and the strong physical sport such as long-distance running, within 2 weeks, follow up a case by regular visits to 1 time.
(4) observation index
Ordinary circumstance: body weight, blood pressure, heart rate, waistline, hip circumference, waist-to-hipratio
Subjective index: observe experimenter's fatigue exponent, by Wessely and Powell mark standards of grading (seeing attached 1);
Blood testing: liver zymetology, blood sugar, four items of blood lipid tests, blood uric acid, insulin level and hs-CRP (Hs-CRP) and free fatty (Free fatty acid, FFA).The whole blood index is measured by clinical laboratory of No.1 Hospital Affiliated to Zhongshan Univ. bio-chemical detector.
Attached 1:
A. physical fatigue scoring
B. mental fatigue scoring
C. tired severity scale (The Fatigue Severity Scale, FSS):
* 1=disagrees with very much, and 7=agrees very much
Scoring<4 belongs to normal.
(4) statistical procedures and the summarization of data
After clinical testing finishes, all clinical datas carry out statistical analysis with SPSS software.Clinical total effects, clinical symptoms etc. after two groups of treatments are carried out to statistical analysis, comparison, and last objective evaluation the present invention coordinates curative effect and the security thereof of EA.
Statistical method: grouped data X
2check, relatively Wilcoxon rank test (correction) of two samples for ranked data, two sample means are relatively with t check or Wilcoxon rank test, before and after self relatively with paired t-test or Wilcoxon pairing rank test, all statistical checks all adopt two-sided test, and the P value is less than or equal to 0.05 and will be considered to checked difference statistical significance is arranged.
(5) result
1, physical data
This research has experimenter's 120 examples, according to the 1:1 principle, is divided at random combustion fat full nutrition low in calories for meal preparation (l-cn group) 60 examples and conventional generation low in calories preparation (control group) 60 examples of eating.
The 120 routine experimenters of this research, Epidemiological Analysis by statistics, the l-cn group mean age is 38 ± 15.3 (y), the control group mean age is 40 ± 16.4 (y), the age no difference of science of statistics; The l-cn group: the male/female ratio is 18/42, control group: the male/female ratio is 15/45; The equal no difference of science of statistics of body weight and BMI.
1 routine alopecia appears in the l-cn group, and 5 examples are slightly weak, 2 example diarrhoea, and 2 routine constipation, end test without 1 example; Control group 1 example diarrhoea, constipation 4 examples, 2 routine alopecias, 9 examples are obviously weak, and 4 examples are because of serious weak termination test.
2, ordinary circumstance relatively
As shown in table 1, after heat restriction in 6 weeks, 2 groups of body weight, body mass index, waistline, hip circumference, waist stern, blood pressures all significantly descend, with control group, compare, l-cn group experimenter body weight, body mass index and waist-to-hipratio all descend significantly, and the combustion fat full nutrition low in calories that l-cn is added in prompting has and significantly reduces the body weight effect for the meal preparation.
Table 1 liang group experimenter's ordinary circumstance
With the treatment before compare, * P value<0.05, * * P value<0.01, NS: no significant difference
3, combustion fat full nutrition low in calories for the meal preparation on glycometabolic impact
As shown in table 2, after heat restriction in 6 weeks, follow Body weight loss simultaneously, experimenter's blood sugar, insulin level all significantly reduce, insulin resistance improves obviously, with control group, compares, and l-cn group blood sugar, insulin level descend more remarkable, difference has statistical significance, points out novel high protein utmost point low-calorie nutrition powder have obvious reduction blood sugar and improve the insulin resistance texts.
4, combustion fat full nutrition low in calories for the meal preparation on lipometabolic impact
As shown in table 2, after heat restriction in 6 weeks, serum free fatty acid, cholesterol, triglycerides, LDL-C, glutamic-pyruvic transaminase and gamma-glutamyl amine transaminase level all significantly descend, and difference has significant difference, and hdl level all significantly raises; With control group, compare, l-cn group triglycerides, free fatty, glutamic-pyruvic transaminase and gamma-glutamyl amine transaminase level all significantly descend, difference has statistical significance, point out novel high protein utmost point low-calorie nutrition pulvis to there is the obvious fat metabolism that improves, promote fat splitting and alleviate the curative effect such as fatty liver.
5, combustion fat full nutrition low in calories impact on inflammation for the meal preparation
As shown in table 2, through heat restriction in 6 weeks, the hs-CRP level all significantly descended; With control group, compare, l-cn group hs-CRP level descends more remarkable, and difference has statistical significance.Point out novel high protein utmost point low-calorie nutrition pulvis to there is the reaction level of reducing inflammation, there is remarkable cardiovascular protection effect.
Table 2 blood parameters
With the treatment before compare, * * P value<0.01, NS: no significant difference
6, combustion fat full nutrition low in calories impact on fatigue exponent for the meal preparation
As shown in table 3, in 6 weeks heat limit procedure, l-cn group experimenter physical fatigue indexed performance is for first raising and descend afterwards, and control group experimenter physical fatigue indexed performance is for raising, with control group, compare, l-cn group experimenter physical fatigue index significantly reduces, and difference has statistical significance (P<0.001).
In 6 weeks heat limit procedure, along with time lengthening, the rear decline that first raises of l-cn group experimenter mental fatigue index, but still higher than level before treatment; With control group, compare, l-cn group experimenter mental fatigue index significantly reduces, and difference has statistical significance (P<0.001).
In 6 weeks heat limit procedure, the rear reduction that first raises of the tired order of severity of l-cn group experimenter, level difference not statistically significant (P=0.654) before treating after 6 weeks, the control group experimenter is along with the heat binding hours extends, the tired order of severity increases gradually, with level difference before treatment, statistical significance (P<0.001) is arranged.
The novel high protein utmost point low-calorie nutrition pulvis of this research prompting can effectively reduce the degree of fatigue occurred in the heat limit procedure, improves tolerance, alleviates uncomfortable reaction.
Table 3 fatigue exponent
7, therapeutic evaluation
Combustion fat full nutrition low in calories for meal preparation and conventional generation low in calories the preparation of eating compare, having the fat splitting of promotion loses weight, reduce blood sugar and insulin level, improve insulin resistance, reduce triglycerides, improve the significant curative effects such as fatty liver and reduction inflammatory reaction, meanwhile, can effectively prevent the weak symptom of fatigue occurred in the heat limit procedure, improve tolerance.
8, discuss
As everyone knows, heat restriction has antiatherosclerosis, improve immunologic function and the effect such as delay senility, but in the heat limit procedure, and that human body very easily occurs is weak, aversion to cold and the not enough performance of lassitude homenergic, greatly limits its clinical practice.
The present invention consists of high protein low-calorie nutrition powder and l-cn, it not only can reduce rapidly body weight in a short time, reduce blood pressure, improve blood sugar, blood fat, insulin sensitivity and liver function, reduce Analysis on Cardiovascular Risk Factors, diabetes, hypertension and coronary heart disease are had to good preventive and therapeutic action, and can improve the highest weak performance of incidence in the heat limit procedure, the raising crowd, to hungry tolerance, is conducive to clinical application.
Embodiment 1
Maltodextrin 30, mineral mixture 1.5, vitamin mixtures 0.5, two dimension mixes in advance for the first time; Add l-cn 2, row two dimension for the second time mixes in advance; Then add rice meal 5, buckwheat 15, soyabean protein powder 25, PURE WHEY 15, the efficient three-dimensional hybrid of sunflower oil 6 row.Sieve, packing, obtain pulvis of the present invention.
Embodiment 2
Maltodextrin 24, mineral mixture 1.8, vitamin mixtures 0.2, two dimension mixes in advance for the first time; Add l-cn 1, row two dimension for the second time mixes in advance; Then add rice meal 13, buckwheat 10, soyabean protein powder 24, PURE WHEY 16, the efficient three-dimensional hybrid of sunflower oil 5 row.Sieve, packing, obtain pulvis of the present invention.
Embodiment 3
Maltodextrin 26, mineral mixture 1.6, vitamin mixtures 0.4, two dimension mixes in advance for the first time; Add l-cn 5, row two dimension for the second time mixes in advance; Then add rice meal 7, buckwheat 12, soyabean protein powder 18, PURE WHEY 20, the efficient three-dimensional hybrid of sunflower oil 10 row.Sieve, packing, obtain pulvis of the present invention.
Embodiment 4
Maltodextrin 23, mineral mixture 2.0, vitamin mixtures 0.2, two dimension mixes in advance for the first time; Add l-cn 4, row two dimension for the second time mixes in advance; Then add rice meal 14, buckwheat 8, soyabean protein powder 30, PURE WHEY 13, the efficient three-dimensional hybrid of sunflower oil 8.8 row.Sieve, packing, obtain pulvis of the present invention.
Embodiment 5
Maltodextrin 25, mineral mixture 1.2, vitamin mixtures 0.3, two dimension mixes in advance for the first time; Add l-cn 6, row two dimension for the second time mixes in advance; Then add rice meal 11, buckwheat 14, soyabean protein powder 15, PURE WHEY 18, the efficient three-dimensional hybrid of sunflower oil 9.5 row.Sieve, packing, obtain pulvis of the present invention.