Cardiovascular DiseasesNCT05290012
The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals
A study testing Dark Chocolate in people with Cardiovascular Diseases, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
In healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood lipid parameters such as; total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels, in addition to fasting blood glucose, HbA1c, CRP levels and blood pressure was investigated. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Dark Chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 17 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 30 kg/m2
- Systolic blood pressure <140 mmHg and/or diastolic blood pressure <90 mmHg
Who cannot join
- Individuals with any diagnosed chronic or acute illness
- Individuals diagnosed or in contact with Covid-19
- Individuals with allergies to cocoa/chocolate products
- Individuals in the process of losing weight
- Individuals with smoking and alcohol consumption
- Individuals taking medication or vitamin/mineral supplements
Show all 9Show fewer
- Individuals doing heavy physical activity
- Individuals who regularly consume cocoa/chocolate products for the last 1 month (> 3 days a week)
- Pregnant or lactating women were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
In healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood lipid parameters such as; total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels, in addition to fasting blood glucose, HbA1c, CRP levels and blood pressure was investigated.
Read the detailed description
Recent studies have shown that dark chocolate consumption may have a positive effect on cardiovascular risk markers.The aim of this study is to investigate the effect of regular consumption of dark chocolate (36 g/day) on biochemical blood parameters in healthy individuals. A total of 37 healthy individuals completed the study conducted in this direction. Participants were randomly divided into two groups as dark chocolate group (n=17) and control group (n=20). While the dark chocolate group consumed 36 g/day (400 mg/day flavanol) dark chocolate for 4 weeks, the control group did not receive any intervention. At the end of the study, the anthropometric measurements of the individuals were evaluated. Blood lipid profile, fasting blood glucose, HbA1c, CRP levels, systolic blood pressure and diastolic blood pressure measurements were investigated.
- Conditions
- Cardiovascular Diseases
- Being tested
- Dark Chocolate
- Keywords
- Chocolate, Cacao, Cholesterol, Blood Glucose, Blood Pressure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark ChocolateOther
A daily consumption of 36 g dark chocolate (400 mg/day flavanol) was made. No Cocoa/chocolate product was consumed other than the intervention product.
| Study group | Role | What they receive |
|---|---|---|
| Dark Chocolate | Experimental | Participants consumed 18 grams of dark chocolate (36 g/day, 400 mg/day of flavanols) twice daily. Receives: Other: Dark Chocolate |
| Control | No intervention | No intervention was made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum lipid levels from baseline with dark chocolate consumption at 4 weeks.
Serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride) were measured by taking blood samples from individuals at the beginning and end of the study. Differences in blood lipid variables were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline serum lipid levels-Week 4 serum lipid levels)
Measured: Baseline and Week 4
Change in glycemic parameters from baseline with dark chocolate consumption at 4 weeks.
At the beginning and end of the study, blood samples were taken from the individuals and their HbA1c and fasting blood glucose levels were measured. Differences in glycemic variables were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline glycemic parameters-Week 4 glycemic parameters)
Measured: Baseline and Week 4
Change in CRP levels from baseline with dark chocolate consumption at 4 weeks.
At the beginning and end of the study, blood samples were taken from the individuals and their CRP (C-reactive protein) levels were measured. Differences in the CRP variable were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline CRP levels-Week 4 CRP levels)
Measured: Baseline and Week 4
Change in blood pressure from baseline with dark chocolate consumption at week 4.
At the beginning and end of the study, the blood pressure (systolic blood pressure and diastolic blood pressure) measurements of the individuals were measured with the Nimo LD-520 digital blood pressure device. Change = (Baseline blood pressure-Week 4 blood pressure)
Measured: Baseline and Week 4
Secondary outcomes (4)
Change in body weight from baseline with dark chocolate consumption at week 4.
The body weight (kg) of the subjects was measured at the beginning and end of the study. The measurement was made with Tanita-BC-601. Change = (Baseline body weight-Week 4 body weight)
Measured: Baseline and Week 4
Change in BMI from baseline with dark chocolate consumption at week 4.
The body mass index (BMI) of individuals at the beginning and end of the study was measured using mathematical calculation (weight/height squared; in kilograms per square metre).Change = (Baseline BMI-Week 4 BMI)
Measured: Baseline and Week 4
Change in body fat percentage from baseline with dark chocolate consumption at week 4.
Body fat percentage (%) of individuals was measured at the beginning and end of the study. The measurement was made with Tanita BC-601. Change = (Baseline body fat percentage-Week 4 body fat percentage)
Measured: Baseline and Week 4
Change in waist circumference from baseline with dark chocolate consumption at week 4.
At the beginning and end of the study, the waist circumference (cm) of the individuals (midway between the rib cage and the iliac crest) was measured using a flexible tape measure. Change = (Baseline waist circumference-Week 4 waist circumference)
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start20 Dec 2020
- Primary completion13 Feb 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kübra Küçükyılmaz, Principal investigator, Eastern Medittanean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290012
- Sponsor's protocol ID
- ETK00-2020-0283
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals
- ClinicalTrials.gov ID
- NCT05290012
- Acronym / sponsor ID
- ETK00-2020-0283
- Conditions
- Cardiovascular Diseases
- Keywords
- Chocolate, Cacao, Cholesterol, Blood Glucose, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 13 Feb 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood lipid parameters such as; total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels, in addition to fasting blood glucose, HbA1c, CRP levels and blood pressure was investigated.
Detailed description
Recent studies have shown that dark chocolate consumption may have a positive effect on cardiovascular risk markers.The aim of this study is to investigate the effect of regular consumption of dark chocolate (36 g/day) on biochemical blood parameters in healthy individuals. A total of 37 healthy individuals completed the study conducted in this direction. Participants were randomly divided into two groups as dark chocolate group (n=17) and control group (n=20). While the dark chocolate group consumed 36 g/day (400 mg/day flavanol) dark chocolate for 4 weeks, the control group did not receive any intervention. At the end of the study, the anthropometric measurements of the individuals were evaluated. Blood lipid profile, fasting blood glucose, HbA1c, CRP levels, systolic blood pressure and diastolic blood pressure measurements were investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark Chocolate | Experimental | Other: Dark ChocolateParticipants consumed 18 grams of dark chocolate (36 g/day, 400 mg/day of flavanols) twice daily. |
| Control | No intervention | –No intervention was made |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI < 30 kg/m2
- Systolic blood pressure <140 mmHg and/or diastolic blood pressure <90 mmHg
Key exclusion criteria (9 listed)
- Individuals with any diagnosed chronic or acute illness
- Individuals diagnosed or in contact with Covid-19
- Individuals with allergies to cocoa/chocolate products
- Individuals in the process of losing weight
- Individuals with smoking and alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark ChocolateA daily consumption of 36 g dark chocolate (400 mg/day flavanol) was made. No Cocoa/chocolate product was consumed other than the intervention product. | Other | Dark Chocolate |
Primary outcome
Change in serum lipid levels from baseline with dark chocolate consumption at 4 weeks.
Time frame: Baseline and Week 4
Serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride) were measured by taking blood samples from individuals at the beginning and end of the study. Differences in blood lipid variables were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline serum lipid levels-Week 4 serum lipid levels)
Change in glycemic parameters from baseline with dark chocolate consumption at 4 weeks.
Time frame: Baseline and Week 4
At the beginning and end of the study, blood samples were taken from the individuals and their HbA1c and fasting blood glucose levels were measured. Differences in glycemic variables were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline glycemic parameters-Week 4 glycemic parameters)
Change in CRP levels from baseline with dark chocolate consumption at 4 weeks.
Time frame: Baseline and Week 4
At the beginning and end of the study, blood samples were taken from the individuals and their CRP (C-reactive protein) levels were measured. Differences in the CRP variable were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline CRP levels-Week 4 CRP levels)
Change in blood pressure from baseline with dark chocolate consumption at week 4.
Time frame: Baseline and Week 4
At the beginning and end of the study, the blood pressure (systolic blood pressure and diastolic blood pressure) measurements of the individuals were measured with the Nimo LD-520 digital blood pressure device. Change = (Baseline blood pressure-Week 4 blood pressure)
4 secondary outcomes
Change in body weight from baseline with dark chocolate consumption at week 4.
Time frame: Baseline and Week 4
Change in BMI from baseline with dark chocolate consumption at week 4.
Time frame: Baseline and Week 4
Change in body fat percentage from baseline with dark chocolate consumption at week 4.
Time frame: Baseline and Week 4
Change in waist circumference from baseline with dark chocolate consumption at week 4.
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kübra Küçükyılmaz principal investigator
Eastern Medittanean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark Chocolate in people with Cardiovascular Diseases, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum lipid levels from baseline with dark chocolate consumption at 4 weeks. (time frame: Baseline and Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.