Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia
Ключови думи
Резюме
Описание
The protocol will be carried out in the Hospital Regional de Alta Especialidad de la Península de Yucatán (HRAEPY). It is quasi-experimental and it was proposed before and after study, the study will be consisting in 6 subsequent visits and a last visit to deliver results to the participant.
In the pre-visit, the subjects will be evaluated to determine if they meet the inclusion criteria. They will be explained what the study consists of, the characteristics, the risks and the expected benefits after the intervention, they will be asked to read the consent letter, doubts will be clarified about it and if the participant agrees to be in the study the signature will be made of the consent letter.
At the beginning and end will be taken two blood samples of 5 mL to each participant. One will be to obtain the serum and measure cholesterol-HDL, cholesterol-LDL, triglycerides, total cholesterol, glucose, antioxidant activity, malondialdehyde (MDA) and C-reactive protein. The second sample will be to the extraction of peripheral leukocyte blood mononuclear cells and determine the gene expression of antioxidants enzymes superoxide dismutase (SOD) and catalase (CAT). Blood pressure will be measured with a digital baumanometer while the participant will remain seated with the right arm uncovered. The measurement will be carried out 6 times, in intervals of 3 minutes. The first measurement will be discarded and the average of the remaining measurements will be reported. In the visits will bring to each participant an attachment to reported intake of the beverage. During the following ones it will always be questioned if there is any problem with the drinking the beverage of Chaya.
At the end of the study, participants will be given the document with their results and will be given recommendations for weight control, dietary recommendations to improve lipid concentrations. They will refer to their doctor for follow-up with their laboratory results for their control.
Description of the intervention
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
Дати
| Последна проверка: | 01/31/2020 |
| Първо изпратено: | 09/25/2019 |
| Очаквано записване подадено: | 09/26/2019 |
| Първо публикувано: | 09/30/2019 |
| Изпратена последна актуализация: | 02/09/2020 |
| Последна актуализация публикувана: | 02/10/2020 |
| Действителна начална дата на проучването: | 05/31/2019 |
| Приблизителна дата на първично завършване: | 09/22/2019 |
| Очаквана дата на завършване на проучването: | 12/06/2020 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Chaya (Cnidoscolus chayamansa)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Chaya (Cnidoscolus chayamansa) Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed. | Dietary Supplement: Chaya (Cnidoscolus chayamansa) Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 20 Years Да се 20 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Male and female. - Adults between 20 and 60 years. - BMI ≥ 20 and ≤ 39.9 kg / m². - Mestizo Mexicans: parents and grandparents born in Mexico. - Patients diagnosed with dyslipidemia. - Dyslipidemia will be defined by any? alteration in the concentrations of the following lipoproteins: LDL cholesterol> 130mg/dL or total cholesterol> 200 mg/dL or triglycerides> 150 mg/dL - Patients should know how to read and write. - Signature of informed consent. Exclusion Criteria: - Patients with any type of diabetes previously diagnosed - Patients with acquired diseases that produce secondary obesity and diabetes. - Patients who have suffered a cardiovascular event. - Weight loss> 3 kg in the last 3 months. - Catabolic diseases such as cancer and acquired immunodeficiency syndrome. - Positive smoking. - Drug treatment: - Antihypertensive drugs (thiacyclic, loop or potassium-sparing diuretics, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers). |
Резултат
Първични изходни мерки
1. Change from baseline triglycerides concentration at 6 weeks of intervention [At the beginning of the study and after 6 weeks of intervention]
2. Change from baseline Lipoproteins concentration at 6 weeks of intervention [At the beginning of the study and after 6 weeks of intervention]
Вторични изходни мерки
1. Change from baseline blood gene expression of superoxide dismutase at 6 weeks of intervention [At the beginning of the study and after 6 weeks of intervention]
2. Change from baseline blood gene expression of catalase at 6 weeks of intervention [At the beginning of the study and after 6 weeks of intervention]
3. Change from baseline serum antioxidant activity at 6 weeks of intervention [At the beginning of the study and after 6 weeks of intervention]
4. Change from baseline serum C-Reactive Protein at 6 weeks of intervention [At the beginning of the study and after 6 weeks of intervention]
