Ginger and Plasma Cholesterol Efflux Capacity
Effect of Oral Supplementation of Ginger on Plasma Cholesterol Efflux Capacity From THP-1 Macrophage
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The relationship between serum high-density lipoprotein cholesterol (HDL-C) and atherosclerosis was initially elucidated by the Framingham study. However, current evidence suggests that maintaining an optimal HDL-C level may not be sufficient to reduce the risk of cardiovascular disease (CVD). The majority of clinical trials have demonstrated that plasma HDL-C-raising drugs do not confer a reduction in the risk of developing CVD. Consequently, there has been a decline in interest in pursuing the elevation of HDL-C levels as a therapeutic objective. Mendelian randomization studies have called into question the causal relationship between plasma HDL-C levels and CVD. This may be due to factors related to HDL function and the reverse cholesterol transport pathway, including the effect of CEC. A number of studies involving large clinical populations have observed a robust inverse correlation between CEC and CVD after adjustment for plasma HDL-C levels. This suggests that CEC may serve as a more reliable biomarker for CVD than plasma HDL-C concentration. The efflux of cholesterol from macrophages may contribute to anti-inflammatory and anti-atherogenic effects, as well as reducing the accumulation of cholesterol esters in macrophages, which in turn leads to the production of foam cells. It is possible that ginger may affect this process. A limited number of in vitro studies have investigated the impact of ginger compounds on CEC, with all studies demonstrating a positive influence on the mediator of the reverse cholesterol transport pathway. These findings are in alignment with the results of an animal study in which hamsters fed a high-fat diet and ginger extract exhibited enhanced CEC. Moreover, it is conceivable that inflammatory processes may impede the efflux of cholesterol and the reverse cholesterol transport pathway. It can be reasonably deduced that the ginger, which exhibits antioxidant and anti-inflammatory properties, may prove beneficial in optimising this pathway. In light of the findings from experimental studies examining the effects of ginger-derived compounds on cholesterol efflux pathways, this study aims to investigate the impact of oral ginger supplementation on HDL function.
The crossover and double-blind study will be conducted in two four-week periods, with a washout period of at least three weeks between the two. The study population will be comprised of individuals who meet the following criteria: individuals between the ages of 18 and 75 years, with a body mass index less than 35 kg/m², who have not used serum lipid-lowering drugs in the previous month and have not regularly consumed ginger or ginger supplements (more than twice a week). In one of the two study periods, participants will ingest a ginger-based supplement in a dosage of 1500 mg, comprising three 500 mg capsules. In the other period, they will receive a placebo in the form of three capsules containing corn flour. A simple randomization method based on the RAS software is employed. To maintain the blind, the placebo and ginger capsules will be packed and coded in similar cans by an individual external to the study, and these capsules will remain sealed. At baseline and end of each study period, 6 cc of venous blood samples will be obtained from individuals after an overnight fast. The plasma and buffy coat (containing white blood cells) will be separated and stored at -80. Anthropometric measurements, including body weight, and blood pressure assessments will be conducted at baseline and end of each period. Additionally, a 24-hour food recall will be performed at both time points. The human monocyte cell line (THP-1) will be cultures in RPMI 1640 medium and subsequently differentiated into macrophage cells through the use of phorbol myristate acetate. Following differentiation, fluorescent cholesterol will be introduced to the culture medium in order to label the cells with this cholesterol. Subsequently, the plasma of the participants will be incorporated into the culture medium. Following the designated incubation period, the medium surrounding the cells will be removed and the cells will be lysed. The fluorescence of cholesterol in the medium and in the extract of THP-1 cells will be quantified using a fluorescence plate reader, allowing the calculation of CEC. The gene expression of ATP-binding cassette transporters A1 (ABCA1) and ATP-binding cassette transporters G1 (ABCG1) in the buffy coat obtained from blood samples of participants will be determined by quantitative polymerase chain reaction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tehran, Iran, Islamic Republic of
- Nutrition Clinic located in the Faculty of Nutrition Sciences, Shahid Beheshti University of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- a body mass index less than 35 kg/m², Exclusion Criteria:
Exclusion Criteria:
- Those with an allergy or sensitivity to ginger
- Those who have used serum lipid-lowering or antiinflammatory drugs in the previous month regularly
- Those who have regularly consumed ginger or ginger supplements (more than twice a week)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ginger
Ginger-based supplement
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Ginger-based supplement in a dosage of 1500 mg
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|
Placebo Comparator: Placebo
Capsules containing corn flour
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Capsules containing corn flour
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ex-vivo plasma cholesterol efflux capacity
Time Frame: up to 6 weeks
|
The ex vivo plasma cholesterol efflux capacity of THP-1 cells labeled with fluorescent cholesterol
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up to 6 weeks
|
|
Expression of ABCA1 and ABCG1
Time Frame: up to 6 weeks
|
The expression of genes encoding the ATP-binding cassette transporters ABCA1 and ABCG1 in peripheral white blood cells
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up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma lipid profile
Time Frame: up to 6 weeks
|
The plasma concentrations of triglycerides, cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
|
up to 6 weeks
|
|
Plasma inflammatory biomarkers
Time Frame: up to 6 weeks
|
The plasma concentrations of c-reactive protein, interleukin 6
|
up to 6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 43008844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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