4. The Design of Research
There were 125 persons under supervision (85 persons in the basic group and 40 persons in the group of comparison), hospitalized into the Clinic of dietetic therapy of State University of Scientific Research Institute of Nutrition of Russian Academy of Medical Science with diagnoses: IIH and HLP with adiposity of I-ІІІ degree. Single-centered, open, randomized controllable research was carried out. According to GCP the informed consent of patients was received. The group of comparison included 40 persons (2 men and 38 women, average age 52,4 years). They received reduced hyposodic antiatherogenous diet Аr, which contained 75 g of protein, 60 g of fat (25 g of which was sunflower oil) and 190 g of carbohydrates with energetic value 1600 kcal. Patients of the first basic group - 25 persons (5 men and 20 women, average age 52,7 years) received a diet in which 20 g of sunflower oil was replaced with the same quantity of the mix of amaranth and corn oil (in the ratio 1:3). Thus the part of squalene was 100 mg per day (25 % of recommended daily need). The 2-nd, 3-rd and 4-th basic groups included 20 persons: in the 2-nd and 3-rd - 2 men and 18 women, in the 4-th - 3 men and 17 women. Average age of them was 59,4, 46,6 and 59,2 years accordingly. The diet in these groups included accordingly 6,12 g and 18 g of amaranth oil instead of the same quantity of sunflower oil. The daily content of squalene for patients of the 2-nd, 3-rd and 4-th basic groups made 200 mg, 400 mg and 600 mg accordingly, or 50 %, 100 % and 150 % of recommended daily need. The course of dietotherapy was carried out within 3 weeks. The chemical composition of developed diets is given in the table 1. Hyposodic antiatherogenous diet Аr, reduced on caloric content, is characterized by reduction of quantity of animal fats, refined carbohydrates, cholesterol contained products and extractive substances. The content of protein in the diet corresponds to physiological norm, products containing lipotropic substances, polyunsaturated fatty acids and food fibres are included.
| Table №1 |
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Chemical composition, power value and fatty-and-acid structure of diet Аr and rations with inclusion of amaranth oil
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| Parameter | Diet Аr | Mix of Oils | Amaranth oil 6g/day | Amaranth oil 12g/day | Amaranth oil 18g/day |
| Protein,g | 75 | 75 | 75 | 75 | 75 |
| Fat,g | 60 | 60 | 60 | 60 | 60 |
| Carbonhydrate,g | 190 | 190 | 190 | 190 | 190 |
| Caloricity,ккал | 1600 | 1600 | 1600 | 1600 | 1600 |
| Fatty acids: |
| SFA,g | 22,831 | 23,217 | 23,502 | 24,173 | 24,844 |
| С 14:0 (myristic) | 5,054 | 5,062 | 5,065 | 5,072 | 5,87 |
| С 15:0 (pentadecylic) | 0,164 | 0,164 | 0,172 | 0,180 | 0,188 |
| С 16:0 (palmitic) | 11,844 | 12,646 | 12,523 | 13,202 | 13,881 |
| С 17:0 (margaric) | 0,288 | 0,318 | 0,350 | 0,412 | 0,474 |
| С 18:0 (stearinic) | 5,062 | 4,682 | 5,007 | 4,952 | 4,897 |
| С 20:0 (arachic) | 0,231 | 0,297 | 0,222 | 0,213 | 0,204 |
| С 22:0 (behenic) | 0,188 | 0,048 | 0,163 | 0,138 | 0,113 |
| МНЖК,г | 21,423 | 22,515 | 21,285 | 21,147 | 21,009 |
| С 14:1 (myristoleic) | 0,455 | 0,455 | 0,455 | 0,455 | 0,455 |
| С 16:1 (palmitoleic ) | 1,852 | 1,879 | 1,860 | 1,868 | 1,876 |
| С 17:1 (heptadecenoic) | 0,008 | 0,008 | 0,008 | 0,008 | 0,008 |
| С 18:1 (oleinic) | 18,707 | 19,708 | 18,515 | 18,323 | 18,131 |
| С 20:1 (gadoleic) | 0,207 | 0,241 | 0,253 | 0,299 | 0,345 |
| С 22:1 (erucidic) | 0,194 | 0,224 | 0,194 | 0,194 | 0,194 |
| PUFA,g | 15,129 | 13,724 | 14,320 | 13,511 | 12,702 |
| С 18:2 (linolic) | 13,424 | 11,761 | 12,560 | 11,696 | 10,832 |
| С 18:3 (linolenic) | 0,275 | 0,533 | 0,330 | 0,385 | 0,440 |
| С 18:4 (octadecatetraenic) | 0,015 | 0,015 | 0,015 | 0,015 | 0,015 |
| С 20:4 (arachidonic) | 0,355 | 0,355 | 0,355 | 0,355 | 0,355 |
| С 20:5 (eicosapentaenic) | 0,042 | 0,042 | 0,042 | 0,042 | 0,42 |
| С 22:5 (docosapentaenic) | 0,902 | 0,902 | 0,902 | 0,902 | 0,902 |
| С 22:6 (docosahexaenic) | 0,116 | 0,116 | 0,116 | 0,116 | 0,116 |
| PUFA w-6/PUFA w-3 | 10,200 | 7,533 | 9,192 | 8,254 | 7,384 |
| PUFA w-3 | 1,575 | 1,608 | 1,405 | 1,460 | 1,515 |
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All patients received the traditional course of treatment including hyposodic antiatherogenous diet, physiotherapy exercises, hydro-and physioprocedures. The basic group and the group of comparison included patients with IIH. Full medical examination was carried out. The electrocardiogram and the echocardiography was made, biochemical parameters were defined for verification of diagnosis.
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