NCT05290012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
Last Updated

March 22, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 21, 2022

Last Update Submit

March 11, 2022

Conditions

Cardiovascular Diseases

Keywords

ChocolateCacaoCholesterolBlood GlucoseBlood Pressure

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

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

    Baseline and Week 4

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

    Baseline and Week 4

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

    Baseline and Week 4

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

    Baseline and Week 4

Study Arms (2)

Dark Chocolate

EXPERIMENTAL

Participants consumed 18 grams of dark chocolate (36 g/day, 400 mg/day of flavanols) twice daily.

Other: Dark Chocolate

Control

NO INTERVENTION

No intervention was made

Interventions

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.

Dark Chocolate

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kübra Küçükyılmaz

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Kübra Küçükyılmaz

    Eastern Medittanean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

March 22, 2022

Study Start

December 20, 2020

Primary Completion

February 13, 2021

Study Completion

March 17, 2021

Last Updated

March 22, 2022

Record last verified: 2022-01

Locations

TU(1)