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Assessment of The Effect of Dark Chocolate 78% on Depression among Menopuasal Women: A Randomized Controled Trial

Protocol summary

Study aim
Determining the effect of 78% dark chocolate on depression (primary outcome) and sleep quality and anthropometric indicators among postmenopausal women (secondary outcomes).
Design
A double-blind randomized controlled clinical trial, 60 postmenopausal women will be assigned to one of the intervention and control groups with a ratio of 1:1, using a computerized random number table and through blocks of six.
Settings and conduct
People will be selected from the health centers of Tabriz, Al-Zahra and Taleghani hospitals. The list of people will be extracted from the Sib system first. The chocolates of both groups will be presented in the same shape and size and similar packages. Due to the difference in the taste of dark and milk chocolate, the outcome evaluation will be blind and a person who was not involved in the sampling will be asked. to check the results at the end of the intervention.
Participants/Inclusion and exclusion criteria
Entry requirements: age 45-65, menopause, having depression, desire to consume chocolate and not allergic to cocoa and any of the components of chocolate. Conditions of non-entry: cardiovascular, digestive, liver or kidney diseases, diabetes mellitus, high blood pressure under treatment, fibrocystic breast problems, dyslipidemia, neurological or neuropsychological diseases, depression under treatment, hormone therapy, habit of daily consumption of cocoa or coffee products. Habitual use of invigorating teas.
Intervention groups
Participants in the intervention group will receive 12 grams of 78% dark chocolate and participants in the control group will receive 12 grams of milk chocolate daily for 8 weeks. The cocoa content of milk chocolates will be less than 2%.
Main outcome variables
Comparison of the average score of depression in the two groups receiving dark chocolate and the control group after the end of the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220926056046N1
Registration date: 2022-12-10, 1401/09/19
Registration timing: prospective

Last update: 2022-12-10, 1401/09/19
Update count: 0
Registration date
2022-12-10, 1401/09/19
Registrant information
Name
Solmaz Ghanbari Homaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3524 5181
Email address
homayisolmaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-15, 1401/09/24
Expected recruitment end date
2023-08-20, 1402/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of The Effect of Dark Chocolate 78% on Depression among Menopuasal Women: A Randomized Controled Trial
Public title
Effect of dark chocolate on depression in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-65 Being menopausal Desire to consume dark chocolate No allergy to cocoa or any of the chocolate components Having mild or moderate depression based on the Beck Depression Questionnaire and the diagnosis of a clinical psychologist
Exclusion criteria:
Cardiovascular disease diabetes mellitus Under traetment high blood pressure Digestive diseases Liver diseases Kidney Diseases Fibrocystic breast problems Under treatment dyslipidemia Under treatment neurological or neuropsychological diseases Under tratment depression Hormone therapy Habit of daily consumption of cocoa or coffee products Habitual use of invigorating drinks Severe depression based on the Beck's questionnaire
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Study participants will be assigned to one of the intervention and control groups with a 1:1 allocation ratio using the random block method with a block size of six using the website www.random.org. In order to hide the allocation (Allocation Concealment), the sequence of allocation will be specified by a person not involved in the study using a randomizer, and dark and milk chocolate will be placed inside the foil and in the same packages that are numbered consecutively.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, the researcher, the collector and the evaluator of the results will be blinded. The chocolates of both groups will be in the same shape and size and same packaging. a person who was not involved in the sampling will be asked to check the outcomes at the end of the intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz university of medical science, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.TBZMED.REC.1401.807

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate

2

Description of health condition studied
Sleep quality
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition

3

Description of health condition studied
Anthropometric indicators
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Depression score
Timepoint
The end of the 8th week after starting to consume chocolate
Method of measurement
Beck Depression Questionnaire

Secondary outcomes

1

Description
Score of sleep quality
Timepoint
The end of the 8th week after starting to consume chocolate
Method of measurement
Pittsburgh Sleep Quality Index

2

Description
Anthropometric indices
Timepoint
The end of the 8th week after starting to consume chocolate
Method of measurement
Seca height gauge and scale and tape measure

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive 12 grams of 78% dark chocolate daily for eight weeks. The nutritional content of dark chocolate per 6 grams will be: energy: 32 kcal, carbohydrates: 3.2 grams, fat: 2.03 grams, salt: 0.025 grams, trans fatty acids: 0 grams. The product will be prepared from Chichak Company in Tabriz.
Category
Treatment - Other

2

Description
Control group:12 grams of milk chocolate daily for eight weeks. The nutritional content of control group chocolate per 6 grams will be: energy: 32 kcal, carbohydrates: 3.2 grams, fat: 2.03 grams, salt: 0.025 grams, trans fatty acids: 0 grams. The cocoa content of milk chocolates will be less than 2%.The product will be prepared from Iran Chocolate (Chichak) Company in Tabriz.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Elham Abdoli
Street address
School of Nursing and Midwiferyو Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
abdolieelham@gmail.com

2

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Elham Abdoli
Street address
School of Nursing and Midwifery, shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
abdolieelham@gmail.com

3

Recruitment center
Name of recruitment center
Health care centers
Full name of responsible person
Elham Abdoli
Street address
School of Nursing and Midwifery, shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
abdolieelham@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Research department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
70312
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Elham Abdoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
abdolieelham@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery school, Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3524 5181
Email
homayisolmaz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homayi
Position
Assestant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3478 5229
Email
homayisolmaz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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