Effect of Astaxanthin intake on expression of miR-146a and miR-126 in plasma, oxidative stress and inflammation markers and glycemic profile, compared with placebo in patients with type 2 diabetes mellitus
Objectives: The aim of this study is to determine the effects of Astaxanthin on some of the oxidative stress and inflammation markers, and blood sugar in patients with type 2 diabetes. Design: This is a triple-blind clinical trial including 48 patients with type 2 diabetes, who are referred to endocrinology clinic at Golestan hospital and have been receiving oral treatments for glycemic control more than six months. Subjects will be followed for a period of 8 weeks on a voluntary manner. Blinding will be done for subjects and researchers and data monitoring committee. Setting, conduct and participants : 48 patients with type 2 diabetes, age 30 to 60 years, BMI 19 to 35 kg per square meter, and do not have a specific disease will be enrolled in this study. Patients will be randomly divided into two groups using random numbers table. Those patients who do not meet study requirements during the study will be excluded. Interventions: The case group (included 24 patients)will receive 8 milligrams of Astaxanthin tablet daily and the control group (included 24 patients) will use placebo tablets with the same color and shape compared with Astaxanthin tablets for 8 weeks. To assess the dietary factors affecting the inflammatory condition in diabetic patients, the total amount of energy, macronutrients and micronutrients will be determined at the beginning and the end of the study. For this purpose three-day food questionnaire will be completed by the patients and will be evaluated .Finally data will be analyzed by N4 software. Patients’ weight will be measured with minimal clothes, without shoes by a digital scale. Main outcome measures: The main variables (consist of body fat percentage; blood pressure and biochemical parameters) will be measured and reported at the beginning and the end of the study, and will be compared with each other with appropriate statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081623645N1
Registration date:2015-12-13, 1394/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-13, 1394/09/22
Registrant information
Name
Nafiseh Shokri Mashhadi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 616135715751
Email address
shokri.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Astaxanthin intake on expression of miR-146a and miR-126 in plasma, oxidative stress and inflammation markers and glycemic profile, compared with placebo in patients with type 2 diabetes mellitus
Public title
Effect of astaxanthin intake in patients affected by type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study, age range between 30-60 years old, Body Mass Index range between 19 and 35 kg per m2, HbA1C more than seven, not to be affected by renal, liver, lung and autoimmune disease, normal thyroid status, patients who have received standard oral treatments for at least six months.
Exclusion criteria:Failure to follow the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Khuozestan, Ahvaz, Ahvaz Jundishapur University of Medical Sciences, Ethics Committee