]>
IRCT20200404046940N1 IRCT 2020-06-07 Shiraz University of Medical Sciences Effects of Spirulina consumption on patients with hypertension Effects of food containing spirulina algae consumption on blood pressure, antropometric parameters, serum lipid profile and inflammation and oxidative stress indices on patients with hypertension 2019-10-07 anticipated 48 Complete https://irct.ir/trial/47011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization based on the method of reversible blocks In this scheme, randomization based on the method of reversible blocks is carried out In the way that 4 blocks of 12 people will be created. These blocks are then randomly placed in two rows, male and female. Through classifying blocks by the gender, at the end of sampling we will have an equal number of male and female participants in both groups (A and B), thereby modifying the effect of gender distortion, Blinding description: In this study, the first step is to allocate a specific pilot that will be used to produce products containing Spirulina and without Spirulina in a factory and will be monitored by the project scientific consultant (food industry specialist) and the researcher to ensure optimal production conditions. After that, the factory is asked to produce a sufficient number of products in the same packaging and different labels A or B. Consultant of the project and production manager are the only people who are aware of the type of packaged products. As a result, the researcher and participants will be blinded. The products are delivered from the factory after production and are given to the patients immediately. In order to concealment, all code predicted by random allocation software is placed in pockets respectively. Pockets related to a women's accidental block are placed in the first box and pockets related to a men's accidental block are placed in the second box. The lids of the boxes are designed so that only the top pocket can be removed each time. The first pocket taken from the women's box will be assigned to the first female client, who will determine which group (A or B) this person will be after opening. The same goes for men. By doing so, the researcher cannot predict which group the next clients will fall into and the interviewer's bias will be curbed. 3 Primary Hypertension. Intervention 1: Intervention group: The group receiving the food product containing spirulina algae would use the product containing 2 grams of Spirulina per day up to 2 months. The products were produced in Tiondasht Keshto Sanaat company. Intervention 2: Control group: The group receiving the food without Spirulina algae. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Zohreh Ghaem Far
Unit 10, Floor 4, Pakdaman Bldg, 17th Alley, Felestin St, Khajeh Ata Blvd
Bandar Abbas Iran (Islamic Republic of) 7916785418 +98 76 3334 8693 zohreh.ghaemfar@gmail.com Shiraz University of Medical Sciences scientific Zohreh Ghaem Far
Unit 10, Floor 4, Pakdaman Bldg, 17th Alley, Felestin St, Khajeh Ata Blvd
Bandar Abbas Iran (Islamic Republic of) 7916785418 +98 76 3334 8693 zohreh.ghaemfar@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Systolic blood pressure 130 mm Hg or more Diastolic blood pressure 80 mm Hg or more Both of the above Between the age of 24 and 65 years 24 years 65 years Both Suffering from cardiovascular, liver, kidney, inflammatory bowel disease, diabetes and thyroid disorders History of cardiac surgery Weight loss of more than 5% in the last 3 months Participate in other studies in the last 6 months Use any supplements or diets Pregnancy and lactation History of inflammation in the past two weeks (including infection, fracture, etc.) I10 Essential (primary) hypertension Treatment - Devices Placebo Intervention group: The group receiving the food product containing spirulina algae would use the product containing 2 grams of Spirulina per day up to 2 months. The products were produced in Tiondasht Keshto Sanaat company Control group: The group receiving the food without Spirulina algae Blood pressure. Timepoint: Measurement of blood pressure before and 60 days after the intervention. Method of measurement: Digital Arm Sphygmomanometer. Serum lipid profile. Timepoint: Before and 60 days after the intervention. Method of measurement: By the means of Pars Azmoon Company kit and auto analyzer BT 1500. Hs-CRP (high-sensitivity C-reactive protein). Timepoint: Before and 60 days after the intervention. Method of measurement: By Enzyme-linked immunosorbent assay (ELISA) kit. Malondialdehyde. Timepoint: Before and 60 days after the intervention. Method of measurement: Thiobarbituric acid method. Shiraz University of Medical Sciences Approved 2020-01-15 Shiraz University of Medical Science Central building of Shiraz University of Medical Sciences Zand St. Shiraz Fars Iran (Islamic Republic of)