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IRCT20150201020891N2 IRCT 2019-06-23 Shiraz University of Medical Sciences Fortification of chocolate with microencapsulated garlic extract and consumption effects of the product on blood pressure, serum lipid profile, inflammatory and oxidative stress indices in patients with hypertension شکلات غنی شده با عصاره بوزدایی شده سیر و فشارخون Fortification of chocolate with microencapsulated garlic extract and consumption effects of the product on blood pressure, serum lipid profile, inflammatory and oxidative stress indices in patients with hypertension 2019-08-23 anticipated 44 Complete https://irct.ir/trial/40108 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: For blocked randomization, 4 blocks with 11 capacities will be created. These blocks, then, stratified in 2 strata based on gender. This block randomization with gender stratification matches two groups for total number of male and female participants, Blinding description: In order to blinding, Both types of chocolates are made in a Chocolate manufacturing factory under supervision of the technical assistant. Then, both intervention and placebo chocolates are packed in the same covers with different labeling: A or B. Technical assistant of the factory and thesis supervisor are the only individuals informed about the content of different labels. N/A Hypertension. Intervention 1: Intervention group: Daily consumption of 10 grams of bitter chocolate (60 percent) enriched with deodorized Garlic extract powder (equivalent to 4 grams of fresh garlic) for six weeks. Intervention 2: Control group: Daily consumption of 10 grams of bitter chocolate (60 percent) enriched with maltodextrin for six weeks. Yes - There is a plan to make this available What will be shared: In this study, only a fraction of the data, including information about the main outcome, can be shared and other personal information of patients whose publication does not have an impact on the interpretation of the results will not be shared. When: Starting the access period from the summer of 2020 To whom: Access to data from this study will only be possible for academic researchers. Conditions: To use the data from this study, a research proposal submission will be required. Where to obtain: Refer to the scientific accountability authorities for which the specifications were previously provided. How to obtain: To access to the present study's documentations, a research proposal is sufficient. Comments:
public Salman Mohammadi
Zand Street
Shiraz Iran (Islamic Republic of) 7135744488 +98 71 3212 2460 s.mohammadi.diet@gmail.com Shiraz University of Medical Sciences scientific Salman Mohammadi
Zand Street
Shiraz Iran (Islamic Republic of) 71357444488 +98 71 3212 2460 s.mohammadi.diet@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Systolic blood pressure >= 130 mmHg or Diastolic blood pressure >= 80 mmHg OR both Shiraz residence Participation willingness 24 years 65 years Both Being in pregnancy or lactation periods Affected with diabetes or thyroid disorders Anticoagulant drug consumption Dietary supplementation of any type I10 Essential (primary) hypertension Treatment - Other Placebo Intervention group: Daily consumption of 10 grams of bitter chocolate (60 percent) enriched with deodorized Garlic extract powder (equivalent to 4 grams of fresh garlic) for six weeks Control group: Daily consumption of 10 grams of bitter chocolate (60 percent) enriched with maltodextrin for six weeks Hypertension. Timepoint: The beginning of the study and the end of the sixth, ninth and fifth weeks. Method of measurement: Digital barometer. Serum lipid levels. Timepoint: The beginning of the study and the end of the sixth, ninth and fifth weeks. Method of measurement: ELISA kits. Serum hsCRP level. Timepoint: The beginning of the study and the end of the sixth, ninth and fifth weeks. Method of measurement: RIA kit. Serum malondealdehyde levels. Timepoint: The beginning of the study and the end of the sixth, ninth and fifth weeks. Method of measurement: Spectrophotometry. Shiraz University of Medical Sciences Approved 2019-06-12 Ethics Committee of Shiraz University of Medical Sciences Zand street Shiraz Fars Iran (Islamic Republic of)