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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Functional drink enriched with ginger
Control beverage without ginger
UCAM
Murcia, Spain
RECRUITINGChange in serum interleukin-1 beta (IL-1β) levels
Evaluation on differences in serum IL-1β levels
Time frame: Day 1 and Day 60
Change in serum interleukin-6 (IL-6) levels
Evaluation on differences in serum IL-6 levels
Time frame: Day 1 and Day 60
Change in plasma homocysteine levels
Evaluation on differences in homocysteine levels
Time frame: Day 1 and Day 60
Change in plasma fibrinogen concentrations
Evaluation on differences in fibrinogen concentrations
Time frame: Day 1 and Day 60
Atherogenic index
Evaluation on differences in atherogenic index. Differences in the Atherogenic Index of Plasma (AIP), calculated as log (triglycerides/HDL-cholesterol), will be evaluated between the intervention and control groups. Additionally, pre-post changes in AIP will be assessed within each group.
Time frame: Day 1 and Day 60
Change in total cholesterol
Evaluation on differences in total cholesterol leveles (mg/dL)
Time frame: Day 1 and Day 60
Change in LDL-cholesterol
Evaluation on differences in LDL-cholesterol (mg/dL) levels
Time frame: Day 1 and Day 60
Change in HDL-cholesterol
Evaluation on differences in HDL-cholesterol (mg/dL) levels
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Time frame: Day 1 and Day 60
Change in triglycerides
Evaluation on differences in triglycerides (mg/dL) levels
Time frame: Day 1 and Day 60
Change in fasting plasma glucose
Evaluation on differences in fasting plasma glucosa (mg/dL) levels
Time frame: Day 1 and Day 60
Change in body weight
Evaluation of differences in body weight (kg)
Time frame: Day 1 and Day 60
Change in body mass index
BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²).
Time frame: Day 1 and Day 60
Change in fat mass
Evaluation of differences in fat mass (%)
Time frame: Day 1 and Day 60
Change in lean mass
Evaluation of differences in lean mass (%)
Time frame: Day 1 and Day 60
Change in blood pressure
Measured as changes in systolic and diastolic blood pressure (mmHg)
Time frame: Day 1 and Day 60