Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05082350 |
| Other study ID # |
CFE/IF/28-20 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Catholic University of Murcia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A controlled clinical intervention study is proposed to determine the effect of black garlic
consumption on biomarkers of cardiovascular function and associated pathologies in a healthy
population at risk for cardiovascular disease. Black garlic is the result of a fermentation
process of common white garlic in which the temperature and humidity are kept constant over a
long period of time. Black garlic is particularly rich in phenolic compounds such as
S-allylcysteine or S-allyl-mercaptocysteine, with antioxidant action. It also provides
vitamin C and other valuable antioxidant substances such as flavonoids.
Description:
A parallel, controlled clinical trial will be performed to assess the effect of garlic on
mild hypercholesterolemia.
The study will conducted in two groups of volunteer: healthy and at cardiovascular risk
(hypercholesterolemic subjects), consuming black garlic, with each individual acting as its
own control. The study will have a total duration of 18 weeks, divided in two stages:
- Stage 1: basal or washout stage of 2 weeks, in which volunteer follow their usual diet
with restrictions
- Stage 2: intervention stage of 16 weeks, in which volunteer consume black garlic Sixty
healthy volunteers (men and women) between 40-65 years old and BMI between 24.9-29.9
kg/m2 will be recruited. From the total of volunteer, 30 will correspond to the Healthy
Group, which should have total blood cholesterol levels less than 200 mg/dL and
LDL-cholesterol less than 135 mg/dL.
The other 30 volunteers correspond to the Cardiovascular Risk Group, which should have total
cholesterol levels between 200-300 mg/dL and LDL-cholesterol levels between 135-175 mg/dL.
Other inclusion criteria established for all volunteers are: no acute or chronic pathology,
(except hypercholesterolemia for the risk group), no taking drugs, hormones or dietary
supplements, no smoking, no pregnancy, no vegetarianism.
The study has been approved by the Ethical Committee of Catholic University of Murcia (UCAM)
and will be carried out in accordance with the Helsinki Declaration of Human Studies.
Recruitment will take place at various Health Centers and at UCAM. All participants will be
informed on the characteristics of the study and, after signing the informed consent, a
routine analysis will be requested to classify the volunteer in the healthy or cardiovascular
risk group.
To avoid bias due to gender, the number of women and men recruited in both groups will be
balanced. The size of the study population has been estimated taking total blood cholesterol
level as the main variable and taking into account that the study design is randomized and
parallel. Considering a statistical power of 80%, a statistical significance level of 5% (one
tail), a standard deviation of 6.5, aiming to estimate a difference of 2.5, the number of
volunteers required is 25 for each group, rising to 30 in anticipation of dropouts. This
number, being two study groups, will allow obtaining results with statistical significance in
other biochemical parameters that would be determined as secondary variables of the study and
that would inform on the effect of black garlic consumption on cardiovascular function and
associated dysfunctions (inflammation, hypertension, endothelial function, diabetes, etc.).
After an initial washout (basal) stage common to all groups, in which the volunteers will
consume their usual diet with restriction in the consumption of fresh garlic and garlic
products, the intervention will start, with the consumption of black garlic for 12 weeks.
Volunteers will be provided with black garlic and they will ensure that no other type of
garlic or culinary seasoning is used.
Dietary and physical activity questionnaire according to the "Global Physical Activity
Questionnarie (GPAQ)" will be compiled in order to collect information on habits and
lifestyle, as well as to ensure the compliance of food restrictions.
During the study, visits will be scheduled on the first day and last day of each stage. The
subjects will come to the Unit on fasting conditions and will provide the first morning
urine. Blood sample will be taken, plasma aliquoted and stored at -80°C until analysis.
