Skip to main content
OpenTrials
Completed

NCT Number: NCT05290012

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kübra Küçükyılmaz

Samsun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dark Chocolate

Other

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Change in body weight from baseline with dark chocolate consumption at week 4.

    Time frame: Baseline and 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)

  2. Change in BMI from baseline with dark chocolate consumption at week 4.

    Time frame: Baseline and 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)

  3. Change in body fat percentage from baseline with dark chocolate consumption at week 4.

    Time frame: Baseline and 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)

  4. Change in waist circumference from baseline with dark chocolate consumption at week 4.

    Time frame: Baseline and 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)

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.