Clinical trial NCT05290012: The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals
Official title: The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Chocolate
Cacao
Cholesterol
Blood Glucose
Blood Pressure
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* BMI \< 30 kg/m2
* Systolic blood pressure \<140 mmHg and/or diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change in serum lipid levels from baseline with dark chocolate consumption at 4 weeks.
timeFrame: Baseline and Week 4
measure: Change in glycemic parameters from baseline with dark chocolate consumption at 4 weeks.
timeFrame: Baseline and Week 4
measure: Change in CRP levels from baseline with dark chocolate consumption at 4 weeks.
timeFrame: Baseline and Week 4
measure: Change in blood pressure from baseline with dark chocolate consumption at week 4.
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change in body weight from baseline with dark chocolate consumption at week 4.
timeFrame: Baseline and Week 4
measure: Change in BMI from baseline with dark chocolate consumption at week 4.
timeFrame: Baseline and Week 4
measure: Change in body fat percentage from baseline with dark chocolate consumption at week 4.
timeFrame: Baseline and Week 4
measure: Change in waist circumference from baseline with dark chocolate consumption at week 4.
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Kübra Küçükyılmaz
Study officials:
affiliation: Eastern Medittanean University
name: Kübra Küçükyılmaz
role: PRINCIPAL_INVESTIGATOR
References: