Ginger and Plasma Cholesterol Efflux Capacity

NCT06662695 | Completed

• 1 other identifier: 43008844
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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 high-density lipoprotein (HDL) function. The crossover and double-blind study will be conducted in two four-week periods, with a minimum of three weeks between these two phases. In one of the two study periods, participants will receive a ginger supplement, while in the other period, they will receive a placebo in the form of capsules. At the outset and end of each study period, venous blood samples will be obtained from the subjects. Plasma and buffy coat (containing white blood cells) will be separated and stored at -80. Cholesterol efflux capacity (CEC) will be determined by adding participants' plasma samples to the culture medium of THP-1 cells. Additionally, the gene expression of ATP-binding cassette transporters (ABCA1) and ABCG1 will be determined in the tissue lining obtained from the blood samples of the participants.

Conditions

Healthy

Keywords

Ginger; HDL; cholesterol efflux; ABCA1

Outcome Measures

Primary Outcomes (2)

• Ex-vivo plasma cholesterol efflux capacity

  The ex vivo plasma cholesterol efflux capacity of THP-1 cells labeled with fluorescent cholesterol

  up to 6 weeks

• Expression of ABCA1 and ABCG1

  The expression of genes encoding the ATP-binding cassette transporters ABCA1 and ABCG1 in peripheral white blood cells

  up to 6 weeks

Secondary Outcomes (2)

• Plasma lipid profile

  up to 6 weeks

• Plasma inflammatory biomarkers

  up to 6 weeks

Study Arms (2)

Ginger

EXPERIMENTAL

Ginger-based supplement

Dietary Supplement: Ginger-based supplement

Placebo

PLACEBO COMPARATOR

Capsules containing corn flour

Dietary Supplement: Placebo

Interventions

Ginger-based supplement DIETARY_SUPPLEMENT

Ginger-based supplement in a dosage of 1500 mg

Ginger

Placebo DIETARY_SUPPLEMENT

Capsules containing corn flour

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Nutrition Clinic located in the Faculty of Nutrition Sciences, Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: November 3, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 7, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

IR (1)