Effect of Ginger Capsules on Inflammation, Oxidative Stress, and Endothelial Function

Ana Mª Garcia Munoz

Status: Enrolling

Conditions: Cardiometabolic Risk Factors; Inflammation Biomarkers; Oxidative Stress

Treatments: Dietary Supplement: Ginger supplement; Dietary Supplement: Placebo capsules without ginger

Study type: Interventional

Funder types: Other

Identifiers

NCT07437222

CE022406B

Details and patient eligibility

About

Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.

Full description

The duration of the study will be 60 days, during which the investigational product or placebo will be consumed daily according to the assigned intervention. Participants will be randomly allocated to the different study arms following a double-blind design.

Enrollment: 50 estimated patients

Sex: All

Ages: 23 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants.
• Age between 23 and 65 years.
• Body mass index (BMI) > 27.5 kg/m².
• Absence of diagnosed chronic diseases.
• Not receiving pharmacological treatment or dietary supplementation on a regular basis.
• Ability to understand the study procedures and willingness to comply with study requirements.

Exclusion criteria

• Presence of acute or chronic diseases not specified in the inclusion criteria.
• Ongoing chronic pharmacological treatment or active use of dietary supplements.
• Major surgery within the previous three months.
• Current smokers or recent former smokers (less than six months since cessation).
• History of clinically relevant food allergies or eating disorders.
• Concurrent participation in another clinical trial or research study.
• Pregnancy or breastfeeding.
• Following an active weight-loss diet.
• Investigator's judgment of unsuitability for study participation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Encapsulated ginger supplement

Experimental group

Description:

Daily consumption of ginger capsules for 60 days.

Treatment:

Dietary Supplement: Ginger supplement

Placebo capsules

Placebo Comparator group

Description:

Daily consumption of placebo capsules for 60 days.

Treatment:

Dietary Supplement: Placebo capsules without ginger