The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals

Cardiovascular Diseases Clinical Trial

Official title:

The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290012
• Other study ID #: ETK00-2020-0283
• Status: Completed
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: March 17, 2021

Study information

• Verified date: January 2022
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 17, 2021
• Est. primary completion date: February 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Dark Chocolate
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.

Locations

Country	Name	City	State
Turkey	Kübra Küçükyilmaz	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and Week 4
Primary	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)	Baseline and Week 4
Primary	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)	Baseline and Week 4
Primary	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)	Baseline and Week 4
Secondary	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)	Baseline and Week 4
Secondary	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)	Baseline and Week 4
Secondary	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)	Baseline and Week 4
Secondary	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)	Baseline and Week 4