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The Effect of Dark Chocolate Consumption on Serum Levels of Lipoprotein(a), Apolipoprotein A-1, Apolipoprotein B, Inflammatory Markers, Oxidative Stress, lipid profile, health-related quality of life and symptoms of anxiety and depression in Hemodialysis Patients

Protocol summary

Study aim
Determining and comparing the mean Lp(a), Apo A-1,Apo B, MDA, IL-6, anthropometric indices (weight, body mass index, waist circumference), blood pressure, depression score, anxiety score, quality of life score, lipid profile, the correlation between changes in lipid profile indices and changes in mental health scores between the dark chocolate recipient group and the control group at the end of the study, and within each group between the beginning and end of the study.
Design
Allocation of participants to the intervention and control groups in this study will be performed using randomized block permutation method with the blockrand package in the R programming environment. The sample size was determined based on the ANCOVA model using G*Power software.
Settings and conduct
The intervention of this study involves the consumption of 50 grams of 83% dark chocolate produced by Farmand Food Industries Company. This product is offered in 25-gram packages, and patients will receive two packages (totaling 50 grams) in each hemodialysis session, to be consumed during the last hour of dialysis under the supervision of the researcher or the ward nurse to ensure full protocol compliance. Study location: Dialysis departments of Firouzgar Hospital and Hashemi Nejad Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Hemodialysis patients with at least three months of hemodialysis history, without any other acute diseases.
Intervention groups
Intervention group: The group receiving 50 grams of 83% dark chocolate for eight weeks on hemodialysis days (3 times a week), along with specialized nutritional counseling for dialysis patients. Control group: The control group that receives specialized nutritional counseling for dialysis patients and continues only their routine care.
Main outcome variables
Lipoprotein a; Apo A-1; Apo B; IL-6; MDA

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091114002709N68
Registration date: 2026-03-31, 1405/01/11
Registration timing: prospective

Last update: 2026-03-31, 1405/01/11
Update count: 0
Registration date
2026-03-31, 1405/01/11
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Dark Chocolate Consumption on Serum Levels of Lipoprotein(a), Apolipoprotein A-1, Apolipoprotein B, Inflammatory Markers, Oxidative Stress, lipid profile, health-related quality of life and symptoms of anxiety and depression in Hemodialysis Patients
Public title
The Effect of Dark Chocolate Consumption on Serum Levels of Lipoprotein(a), Apolipoprotein A-1, Apolipoprotein B, Inflammatory Markers, Oxidative Stress, lipid profile, health-related quality of life and symptoms of anxiety and depression in Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's consent to participate in the study and signify informed consent form The number of hemodialysis three times per week At least three months of history of hemodialysis BMI>30
Exclusion criteria:
Active infectious diseases including hepatitis and malignancies Allergy or intolerance to dark chocolate in the intervention group Regular consumption of dark chocolate in the daily diet Being on the threshold of kidney transplantation Consumption of antioxidant supplements or similar herbal products in the past 3 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to the intervention and control groups in this study using the randomized block method with the blockrand package in the R programming environment. The main goal of employing this method is to maintain balance in the number of individuals in each group during the data collection process and prevent imbalances resulting from the timing of participant recruitment. In the randomized block method, allocation occurs in consecutive blocks; such that in each block, an equal number of individuals are assigned to the intervention and control groups. In this study, a block size of 4 has been selected; meaning that in each block, two individuals are assigned to the intervention group (A) and two to the control group (B). The order of individuals within each block is determined randomly to reduce the predictability of the allocation pattern.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee School of Health, Iran University of Medical Sciences
Street address
Arjantin Square, Alvand Street, School of Health, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516846514
Approval date
2026-01-26, 1404/11/06
Ethics committee reference number
IR.IUMS.SPH.REC.1404.020

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis

Primary outcomes

1

Description
Lipoprotein (a)
Timepoint
The beginning of the study (before the start of the intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Immunoturbidometric method

Secondary outcomes

1

Description
Apolipoprotein A-1
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Immunoturbidometric method

2

Description
Apolipoprotein B
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Immunoturbidometric method

3

Description
Inflammatory factor IL-6
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA test

4

Description
MDA
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA test

5

Description
Lipid profile
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
TG, HDL-C and TC concentrations will be measured calorimetrically and LDL-C concentrations will be calculated using the Friedwald formula. .LDL-C (mg/dL) = TC (mg/dL) − HDL-C (mg/dL) – (TG (mg/dL)/5)

6

Description
Anxiety and depression score
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Hospital Anxiety and Depression Scale questionnaire

7

Description
health-related quality of life score
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Kidney Disease Quality of Life-36 questionnaire

8

Description
Blood pressure
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Digital blood pressure monitor

9

Description
Anthropometric indices
Timepoint
The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention)
Method of measurement
Standard meter and scale

Intervention groups

1

Description
Intervention group: Patients undergoing hemodialysis who will receive a specified amount of dark chocolate daily for a specified duration, in addition to their usual diet.
Category
Lifestyle

2

Description
Control group: Eligible hemodialysis patients who are randomly assigned to the control group and, throughout the study period, will follow only their usual diet without receiving dark chocolate.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminejad hospital
Full name of responsible person
Dr.Shahrzad Ossareh
Street address
Vali Asr Street (AJ), above Vanak Square, Shahid Valinejad Alley, Shahid Hashminejad Hospital
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
hkciums1403@gmail.com

2

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Farahnaz Dadras
Street address
Vali Asr Square, Behafarin Street, Firoozgar hospital
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1000
Email
firoozgarhospital1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Street address
Tehran Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
farzadshidfar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2755
Fax
+98 21 8862 2533
Email
shidfar.f@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad shidfar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8860 2218
Fax
+98 21 8860 2219
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2755
Fax
+98 21 8862 2533
Email
shidfar.f@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data related to study outcomes at the end of the study can be shared.
When the data will become available and for how long
The access period will be 6 months after publication.
To whom data/document is available
Researchers employed in academic and scientific institutions.
Under which criteria data/document could be used
For the purpose of using the data to conduct another study and apply it to patients.
From where data/document is obtainable
Name and surname: Dr. Farzad Shidfar Email address: shidfar.f@iums.ac.ir
What processes are involved for a request to access data/document
Request via email along with providing complete explanations regarding the reason for needing the data.
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