IRCT | The effect of astaxanthin supplementation on inflammatory markers, oxidative stress indices, lipid profile, uric acid level, blood pressure, endothelial function, quality of life and disease symptoms in heart failure subjects.

Protocol summary

Study aim: To assess the impact of astaxanthin supplementation on inflammatory markers, oxidative stress indices, lipid profile, uric acid level, blood pressure, endothelial function, quality of life, and disease symptoms in individuals with heart failure.
Design: A clinical trial with a control group, with parallel groups, double-blind, randomized, on 80 patients, will be used for randomization by permutation block method with a block size of 4.
Settings and conduct: Samples will be taken from heart failure patients referred to Shahid Chamran Hospital of Isfahan. Blinding of participants and intervention providers will be conducted.
Participants/Inclusion and exclusion criteria: The inclusion criteria: age 18 years and above, known heart failure in stage C, D, willing to participate in the study and complete the consent form before starting the intervention. The exclusion criteria: pregnancy and breastfeeding, consumption of alcoholic beverages, drug addiction, suffering from uncontrolled diabetes, use of herbal and medicinal supplements three months before starting the study, Warfarin drug use, following a special diet or exercise program, suffering from chronic liver, kidney and lung diseases, suffering from chronic inflammatory diseases such as Crohn's and ulcerative colitis, suffering from cancer, suffering from acute coronary heart syndrome or heart surgery in the last 4 weeks.
Intervention groups: The intervention group will receive a daily 20mg Astaxanthin capsule from "Life Technology of Life", while the control group will receive a daily 20mg Maltodextrin placebo capsule from Foodchem, with similar characteristics to the Astaxanthin supplement, for 60 days.
Main outcome variables: Inflammatory markers; oxidative stress indices; lipid profile; blood pressure; uric acid; endothelial function; quality of life; fatigue intensity; shortness of breath intensity; appetite level

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200429047235N3

Registration date: 2024-03-26, 1403/01/07

Registration timing: prospective

Last update: 2024-03-26, 1403/01/07

Update count: 0
Registration date: 2024-03-26, 1403/01/07

Registrant information: Name

Marzieh Kafeshani

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 3792 3169

Email address

kafeshani_nut@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-07-21, 1403/04/31
Expected recruitment end date: 2024-10-20, 1403/07/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of astaxanthin supplementation on inflammatory markers, oxidative stress indices, lipid profile, uric acid level, blood pressure, endothelial function, quality of life and disease symptoms in heart failure subjects.

Public title: Investigating the effect of astaxanthin supplementation on heart failure
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Age 18 years and above known heart failure in stage C, D based on American Heart Association(AHA) criteria and cardiologist diagnosis Willingness to participate in the study and completion of the consent form

Exclusion criteria:

Pregnancy and breastfeeding Consumption of alcoholic beverages Drug addiction Suffering from uncontrolled diabetes Use of herbal and medicinal supplements especially antioxidant supplements three months before starting the study Warfarin drug use Following a special diet or exercise program Suffering from chronic liver, kidney and lung diseases Suffering from chronic inflammatory diseases such as Crohn's and ulcerative colitis Suffering from cancer Suffering from acute coronary heart syndrome or heart surgery in the last 4 weeks.
Age: From 18 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 80

Randomization (investigator's opinion)

Randomized

Randomization description

The participants will be randomly assigned to either the intervention or placebo groups using permuted block randomization with block size of 4 generated by statistical software or Sealed Envelope website. Both the astaxanthin supplement capsules and the placebo will be coded by someone outside the study as code A and B, respectively. The codes will remain undisclosed to the individuals involved in the study's implementation until the end of the study to ensure concealment

Blinding (investigator's opinion)

Double blinded

Blinding description

This study employs a double-blind approach, where patients and investigators are unaware of the type of product being administered. Patients receive either the intervention or placebo in indistinguishable packaging (same taste, smell, color and appearance)

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Isfahan University of Medical Sciences

Street address

Department of Medical Ethics, Ground floor, Building No. 3, Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib street, Isfahan city

City

Isfahan

Province

Isfehan

Postal code

8174673461
Approval date: 2024-03-19, 1402/12/29
Ethics committee reference number: IR.MUI.PHANUT.REC.1402.099

Health conditions studied

1

Description of health condition studied: Heart failure
ICD-10 code: I50
ICD-10 code description: Heart failure

Primary outcomes

1

Description: Oxidative stress indices (malondialdehyde, superoxide dismutase, total antioxidant capacity)
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Blood test

2

Description: Inflammatory markers (C-reactive protein, monocyte chemoattractant protein-1, tumor necrosis factor alpha)
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Blood test

3

Description: Lipid profile
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Blood test

4

Description: Uric acid level
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Blood test

5

Description: Blood pressure
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Mercury sphygmomanometer

6

Description: Endothelial function (nitric oxide level)
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Blood test

7

Description: Quality of Life
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: The Minnesota Living with Heart Failure Questionnaire (MLHFQ)

8

Description: Fatigue severity
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Fatigue Severity Scale (FSS)

9

Description: severity of shortness of breath
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Modified Medical Research Council (MMRC) dyspnea scale

10

Description: Appetite score
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention)
Method of measurement: Simplified Nutritional Appetite Questionnaire (SNAQ)

Secondary outcomes

1

Description: Weight
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after taking the supplement (the end of the intervention)
Method of measurement: Body weight is measured with an approximate of 0.1 kilograms in the morning while fasting, without shoes and with minimal clothing by a digital scale.

2

Description: Waist circumference
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after taking the supplement (the end of the intervention)
Method of measurement: Waist circumference is also measured with an approximate of 0.1 centimeters from the area of the smallest diameter between the last rib or the lower edge of the chest and the crest of the frontal superior iliac spine with a non-stretchable tape measure while the person is standing, measured and recorded.

3

Description: Body Mass Index (BMI)
Timepoint: The beginning of the study (before the start of the intervention) and 60 days after taking the supplement (the end of the intervention)
Method of measurement: BMI is calculated by dividing weight (kilograms) by the square of height (meters).

Intervention groups

1

Description: Intervention group: Patients will take one capsule of Astaxanthin daily (containing 20 milligrams of Astaxanthin) made by the company "Zist Fanavary Taravat Zendegi" located at Alzahra University, for 60 consecutive days
Category: Rehabilitation

2

Description: Control group: They will take a Foodchem-branded daily placebo capsule (containing 20 milligrams of maltodextrin), prepared by Osina Shimi, packaged and similar in color, smell, taste, and appearance to Astaxanthin supplement, continuously for 60 days.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Shahid Chamran hospital

Full name of responsible person

Shirin Ghotbbodin Mohammadi

Street address

No.55, Shahid Hamzeh alley, Bozorgmehr Ave, Isfahan

City

Isfahan

Province

Isfehan

Postal code

8157756184

Phone

+98 31 3267 9472

Email

mohammadi.shirin66@gmail.com

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Gholamreza Askari

Street address

Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences, Hazar Jarib St

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 3060

Email

askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Esfahan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Marzieh Kafeshani

Position

professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Hezarjerib Ave, Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 3169

Fax

Email

kafeshani_nut@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Marzieh Kafeshani

Position

professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Hezarjerib Ave, Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 3169

Fax

Email

kafeshani_nut@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Shirin Ghotbbodin Mohammdi

Position

University student

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

No.55, Shahid Hamzeh alley, Bozorgmehr Ave.

City

Isfahan

Province

Isfehan

Postal code

8157756184

Phone

+98 31 3267 9472

Email

mohammadi.shirin66@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Potential data on primary and secondary consequences is shareable after making individuals unidentifiable
When the data will become available and for how long: 3 months after printing the results
To whom data/document is available: Academic and scientific institutions
Under which criteria data/document could be used: If they have an official letter from the relevant university or scientific institute, they are allowed to use the data.
From where data/document is obtainable: Dr. Marzyeh Kafeshani kafeshani_nut@yahoo.com
What processes are involved for a request to access data/document: Their written request should be sent to the above email along with the confirmation of the relevant university. The data will be emailed as soon as possible.
Comments

The effect of astaxanthin supplementation on inflammatory markers, oxidative stress indices, lipid profile, uric acid level, blood pressure, endothelial function, quality of life and disease symptoms in heart failure subjects.