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IRCT20221022056263N1 IRCT 2023-01-14 Shiraz University of Medical Sciences Effects of whey protein isolate consumption on patients undergoing cardiac surgery Evaluating the effects of whey protein isolate on cardiovascular risk factors and quality of life in patients undergoing coronary artery bypass grafting 2021-11-15 anticipated 42 Complete https://irct.ir/trial/66610 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is used to assign each participant to the intervention or control group. The participants are randomized with block sizes of 4, so that an equal number of individuals will be assigned to the whey protein or the placebo group. Six possible sequences (including AABB, ABAB, ABBA, BAAB, BABA, BBAA) can be made by this method. Each of the sequences will be randomly selected by numbering them from 1 to 6 and using dice, Blinding description: The study participants are blinded. In fact, whey protein isolate and starch powders are packaged similarly and it is not clear to which of the study groups they belong. The researchers do not also provide any information regarding this issue with the participants. 3 patients undergoing coronary artery bypass grafting. Intervention 1: Intervention group: Ten grams of whey protein isolate (once a day) for a period of 14 days will be consumed orally after dissolving in water. Intervention 2: Control group: Three grams of wheat starch powder (once a day) for a period of 14 days will be consumed orally after dissolving in water. Yes - There is a plan to make this available What will be shared: Unidentifiable data of primary outcomes will be shared. When: one month following publication of the article To whom: university researchers Conditions: In case of requesting the data for performing secondary studies Where to obtain: Mahsa Moazen, School of Nutrition and Food Sciences, Shiraz, Iran +987137251001 How to obtain: Approximately two weeks after the request, data will be provided. Comments:
public Maryam Mohammad-Hosseini
Al-Zahra heart hospital, Sibooye Blvd.
Shiraz Iran (Islamic Republic of) 7164954937 +98 71 3735 5041 maryammh63@yahoo.com Shiraz University of Medical Sciences scientific Mahsa Moazen
School of Nutrition and Food Sciences, Razi Blvd.
Shiraz Iran (Islamic Republic of) 7554171536 009837258099 mahsa_moazen@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) patients who are undergoing coronary artery bypass grafting age 30-75 years 30 years 75 years Both heart surgery for the second time simultaneous surgeries (such as heart valve surgery) ejection fraction lower than 30 patients with renal failure patients with liver cirrhosis patients with cancer having metabolic amino acid disorders (such as phenylketonuria) patients with malabsorptive syndrome having celiac disease allergy to milk and dairy products patients with Alzheimer's disease patients with active infection pregnant women lactating women receiving levodopa or albendazole medications I25.709 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris Treatment - Drugs Placebo Intervention group: Ten grams of whey protein isolate (once a day) for a period of 14 days will be consumed orally after dissolving in water. Control group: Three grams of wheat starch powder (once a day) for a period of 14 days will be consumed orally after dissolving in water. Fasting blood glucose. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: colorimetric method. Serum triglyceride. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: colorimetric method. Serum total cholesterol. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: colorimetric method. Low-density lipoprotein cholesterol (LDL-C). Timepoint: Before the start of intervention and 14 days after it. Method of measurement: colorimetric method. High-density lipoprotein cholesterol (HDL-C). Timepoint: Before the start of intervention and 14 days after it. Method of measurement: colorimetric method. Serum albumin. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: colorimetric method. Quality of life determined by MacNew questionnaire. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: MacNew Heart Disease health-related quality of life questionnaire. Atherogenic Index of plasma. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: logarithm of triglyceride (mmol/l) to high-density lipoprotein cholesterol (mmol/l) ratio. Total cholesterol to high-density lipoprotein cholesterol (HDL-C) ratio. Timepoint: Before the start of intervention and 14 days after it. Method of measurement: total cholesterol divided by high-density lipoprotein cholesterol. Low-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio (LDL-C/HDL-C). Timepoint: Before the start of intervention and 14 days after it. Method of measurement: low-density lipoprotein cholesterol divided by high-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio (non-HDL-C/HDL-C). Timepoint: Before the start of intervention and 14 days after it. Method of measurement: First of all, high-density lipoprotein cholesterol (HDL-C) is subtracted from total cholesterol to determine non-high-density lipoprotein cholesterol (non-HDL-C). Then, non-HDL-C is divided by HDL-C. Shiraz University of Medical Sciences Approved 2021-08-15 Ethics committee of Shiraz University of Medical Sciences School of Nutrition and Food Sciences, Razi Blvd. Shiraz Fars Iran (Islamic Republic of)