Nutritional Intervention With Black Garlic

NCT05082350 | Unknown

• 1 other identifier: CFE/IF/28-20
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypercholesterolemia; Hypertension; Hyperlipidemias; Inflammation; Endothelial Dysfunction

Keywords

black garlic; sulphur bioactive compounds; hypercholesterolemia; hyperlipemia; inflammation; endothelial dysfunction

Outcome Measures

Primary Outcomes (2)

• Impact on blood pressure

  Blood pressure (diastolic, systolic)

  changes observed from baseline at day 0 compared to 12 weeks.

• Impact on lipid profile

  Plasma levels of total cholesterol, HDL, LDL, VLDL (very low-density lipoprotein), triglycerides, apolipoproteins A1 and B.

  changes observed from baseline at day 0 compared to 12 weeks.

Secondary Outcomes (9)

• Impact on blood cells (Hematology)

  changes observed from baseline at day 0 compared to 12 weeks.

• evaluation of liver function to determine product safety

  changes observed from baseline at day 0 compared to 12 weeks.

• Changes in cytokine levels

  changes observed from baseline at day 0 compared to 12 weeks.

• Changes in chemokine MCP-1 (monocyte chemotactic protein)

  changes observed from baseline at day 0 compared to 12 weeks.

• Changes in C reactive protein

  changes observed from baseline at day 0 compared to 12 weeks.

Study Arms (2)

Healthy Group,

EXPERIMENTAL

Daily consumption of 4 cloves of black garlic, not cooked, during 12 weeks

Dietary Supplement: black garlic

Hypercholesterolemia

EXPERIMENTAL

Daily consumption of 4 cloves of black garlic, not cooked, during 12 weeks

Dietary Supplement: black garlic

Interventions

black garlic DIETARY_SUPPLEMENT

Daily consumption of 4 cloves of black garlic, not cooked, during 12 weeks

Healthy Group,; Hypercholesterolemia

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Group:
• Total blood cholesterol levels of less than 200 mg/dL
• LDL-cholesterol levels of less than 135 mg/dL
• Not suffer from any other pathology.
• No drugs, hormones or dietary supplements, no smoking, no pregnancy, no vegetarianism, etc.
• Cardiovascular Risk Group:
• Total cholesterol levels between 200-300 mg/dL
• LDL-cholesterol levels between 135-175 mg/dL.
• No acute or chronic pathology, except hypercholesterolemia
• No drugs, hormones or dietary supplements, no smoking, no pregnancy, no vegetarianism, etc.).

Sponsors & Collaborators

• Maria Pilar Zafrilla Rentero: lead
• Instituto de Investigación y formación agraria y pesquera (IFAPA): collaborator

Study Sites (1)

Universidad Católica de Murcia (UCAM)

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hypertension; Hyperlipidemias; Inflammation

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vicedean of Pharmacy Degree

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: October 18, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)