Effect of a Mixture of Allium Extracts on LDL Cholesterol... | NCT04646382

Studies
Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels

NCT04646382

Sponsor

DOMCA S.A.

Status

Completed

Last Update Posted

Feb 23, 2023Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Cardiovascular Health

Interventions

Garlic and onion concentrate
Control

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Dec 29, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Oct 22, 2020

First Submission Date that Met QC Criteria

Nov 27, 2020

First Posted Date

Nov 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune system will also be analyzed.

Detailed Description

It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.

64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups: control group and intervention group.

For 8 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.

Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and health-related data were also measured.

Parameters related to lipid metabolism, metabolic syndrome and the immune system will be analized.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Microcrystalline cellulose (9892- Capsules®) up to 400 mg.	Dietary Supplement: Garlic and onion concentrate Dietary Supplement: Control
Intervention	Experimental	Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.	Dietary Supplement: Garlic and onion concentrate Dietary Supplement: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Garlic and onion concentrate	Dietary Supplement	Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL	Serum LDL cholesterol	8 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Cholesterol	Serum total cholesterol	8 weeks
HDL	Serum HDL cholesterol	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

LDL-cholesterol levels between 100 and 190 mg/dL.
Freely agree to participate in the study and sign the informed consent document.

Exclusion Criteria:

Be pregnant.
Have planned to change lifestyle and / or dietary habits.
Having diabetes.
Having a cerebrovascular disease.
Having a serious illness.
Taking products or drugs to control cholesterol levels or with antioxidant activity.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel Quesada, MD	Endocrinology and Nutrition Clinic of Dr. Miguel Quesada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Domca Sau		Alhendín	Granada	18620	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D005079	Excipients

Ancestor Terms

ID	Term
D014677	Pharmaceutical Vehicles
D010592	Pharmaceutic Aids
D004364	Pharmaceutical Preparations
D020313	Specialty Uses of Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

Each volunteer is assigned a "participant number" that will be associated with a pot that will have all the product for the study.

The "pot number" is the same as the "participant number".

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor